VRTX

Vertex Pharmaceuticals stock has delivered strong multi year gains, and current valuation checks suggest the shares now look closer to fairly priced than clearly cheap or clearly expensive. Vertex Pharmaceuticals has returned 184.9% over the past 5 years, which puts extra focus on whether the current price still offers an appealing entry point for new money. Expectations for continued revenue and cash flow growth from its existing treatment portfolio can support today’s valuation, while any setback in clinical execution or pricing pressure may weigh on how durable those cash flows look. The broader valuation checks are mixed rather than decisive, with a value score of 3 that does not flag Vertex Pharmaceuticals as either a clear bargain or an obvious outlier on price. The issue now is whether the current share price of Vertex Pharmaceuticals offers enough potential upside to justify the risks after such a strong 5 year run. Compare Vertex Pharmaceuticals’ strong 5 year run with other stocks that pair solid balance sheets and fundamentals by scanning the hand picked solid balance sheet and fundamentals stocks screener (53 results). The P/E ratio is a useful check for a profitable company like Vertex Pharmaceuticals because it ties the share price directly to current earnings. Vertex Pharmaceuticals trades on a P/E of about 31.5x, which is higher than the broader biotechs industry average of roughly 16.8x but below the peer group average around 39.4x. That suggests investors are already paying a premium relative to the overall sector, while still not assigning the highest multiples seen among closer peers. A fair P/E level that takes account of Vertex Pharmaceuticals’ size, margins, industry and risk profile is estimated at about 31.3x. The current 31.5x multiple is very close to this mark, so the shares are not screening as clearly cheap or clearly expensive on earnings alone. For you as an investor, this points to a market view that current earnings power is largely reflected in the price. On the P/E multiple, Vertex Pharmaceuticals stock currently appears roughly fairly valued. See what the numbers say about this price — find out in our valuation breakdown. This is where Simply Wall St Narratives come in for Vertex Pharmaceuticals, since they spell out which views on future growth, margins and earnings would need to prove accurate for the stock to be worth materially more or materially less than today's price on the Community page. Each one links its number to a clear view of how Vertex Pharmaceuticals' growth, profitability and risk profile might evolve, which you can revisit as new information comes through. The community is split on Vertex Pharmaceuticals, with one camp seeing meaningful upside and the other worried that expectations already run too hot. Bull case: 19% undervalued Read the full Bull Case to see why Vertex Pharmaceuticals could be undervalued Bear case: 29% overvalued Read the full Bear Case to see why Vertex Pharmaceuticals could be overvalued Do you think there's more to the story for Vertex Pharmaceuticals? Head over to our Community to see what others are saying! Vertex Pharmaceuticals now looks priced roughly in line with what its current earnings power and peer comparisons imply, rather than clearly cheap or clearly expensive. That leaves less room for valuation alone to drive returns, so the debate shifts to how durable its cash flows prove and how well the late stage pipeline performs. For you as an investor, the key question is whether Vertex Pharmaceuticals can sustain the kind of growth and profitability the market is already paying for, without unexpected setbacks on execution, regulation or pricing. This article by Simply Wall St is general in nature. We provide commentary based on historical data and analyst forecasts only using an unbiased methodology and our articles are not intended to be financial advice. It does not constitute a recommendation to buy or sell any stock, and does not take account of your objectives, or your financial situation. We aim to bring you long-term focused analysis driven by fundamental data. Note that our analysis may not factor in the latest price-sensitive company announcements or qualitative material. Simply Wall St has no position in any stocks mentioned. Companies discussed in this article include VRTX. Have feedback on this article? Concerned about the content? Get in touch with us directly. Alternatively, email [email protected]

It has been about a month since the last earnings report for Vertex Pharmaceuticals (VRTX). Shares have added about 14.4% in that time frame, outperforming the S&P 500. Will the recent positive trend continue leading up to its next earnings release, or is Vertex due for a pullback? Before we dive into how investors and analysts have reacted as of late, let's take a quick look at its latest earnings report in order to get a better handle on the important catalysts. Vertex reported adjusted earnings of $4.73 per share for the second quarter of 2026, missing the Zacks Consensus Estimate of $4.79. Earnings, however, rose around 4.6% year over year on higher product revenues, partially offset by higher operating expenses.Second-quarter total revenues of $3.33 billion beat the Zacks Consensus Estimate of $3.23 billion. Total revenues rose 12% year over year, primarily driven by higher sales of CF drugs Trikafta/Kaftrio and Alyftrek, as well as meaningful contributions from other new products, Journavx and Casgevy. Its total revenues rose 11% year over year in the United States to $2.06 billion, driven by strong demand for CF drugs, higher realized net prices in CF and Casgevy and Journavx sales. Outside the U.S. market, sales increased 14% to $1.28 billion, driven by strong CF growth, contribution from Casgevy and a favorable impact from foreign exchange. Trikafta generated sales worth $2.50 billion, down around 2% year over year. The product’s sales slightly beat the Zacks Consensus Estimate of $2.45 billion.Alyftrek generated sales worth $573.6 million in the second quarter, up 35% on a sequential basis. The drug surpassed $1 billion in global revenues in the first half of 2026. Growth was driven primarily by patients switching from Trikafta, along with new-to-therapy patients and strong uptake in Europe. Expansion into rare mutations and younger patients should support further growth.Revenues from other CF products (including Kalydeco, Orkambi, and Symdeko/Symkevi) decreased 29.2% year over year to $137.1 million. Vertex expects incremental patients from the label expansions for Alyftrek and Trikafta, along with launches of Alyftrek in additional geographies and for treating younger patients, to drive CF growth through the rest of the year.Casgevy’s sales were $76.4 million in the second quarter, up 78% on a sequential basis and 151% on a year-over-year basis due to an increase in patient infusions. Casgevy recorded more than 100 patient initiations in the second quarter as the launch continues to progress. First-half 2026 infusions already exceeded the total for 2025, supported by improved reimbursement and growing patient uptake across key markets.In 2026, Vertex expects continued quarter-to-quarter variability in Casgevy infusions.Journavx (suzetrigine) generated $49.6 million in sales in the second quarter, up 71% on a sequential basis. Journavx sales in the second quarter benefited from both strong underlying prescription growth and inventory restocking by distributors, following a reduction in channel inventory during the first quarter.More than 535,000 prescriptions were written for Journavx across both hospital and retail settings in the quarter, compared with approximately 350,000 in the first quarter, showing that uptake is accelerating. In 2026, Vertex expects Journavx prescriptions to triple compared to 550,000 written in 2025, supported by a larger commercial field force, wider payer coverage and improving gross-to-net economics. Vertex is reasonably confident of exceeding the goal.Journavx’s reimbursement trends are also improving, with coverage now reaching approximately 260 million lives. Vertex expanded access further by securing agreements with two additional Medicare Part D plans effective July 1. Journavx is now covered by three out of four of the major Medicare Part D PBMs. In addition, 23 states now cover Journavx through Medicaid. Adjusted research and development (R&D) expenses increased 1.2% year over year to $888.7 million.Adjusted selling, general and administrative (SG&A) expenses rose 44.7% to $520.2 million in the reported quarter, primarily to support the launch of Journavx and the upcoming launches in renal.During the quarter, Vertex recorded acquired in-process research and development (AIPR&D) costs of $21.4 million compared with $2.2 million in the year-ago quarter.Adjusted operating income rose 7.5% year over year to $1.42 billion in the quarter. Vertex increased its full-year 2026 revenue guidance backed by a strong first-half performance.The company now expects total revenues to be in the range of $13.10-$13.20 billion for 2026 compared with the previous expectation of $12.95-$13.10 billion. Global CF revenues grew 8% in the first half of 2026, helped by prior-year U.S. price increases and favorable foreign exchange. However, Vertex expects these benefits to fade in the second half.Vertex expects its non-CF product revenues to be more than $500 million in 2026, representing more than 185% year-over-year growth from 2025, reflecting higher patient infusions for Casgevy and a ramp-up in Journavx prescriptions.The revenue guidance also includes an expected 150 basis point benefit from foreign exchange.Combined adjusted R&D, AIPR&D and SG&A expense guidance for 2026 was maintained in the range of $5.65-$5.75 billion. However, the company now expects to be at the high end of that range. Adjusted gross margin is expected to be under 86%. The adjusted tax rate is expected to be in the range of 19.5%-20.5%. Both remain unchanged from the previous expectation.The guidance does not reflect the impact of the pending Crinetics acquisition, which is expected to be closed in the third quarter. It turns out, estimates revision have trended downward during the past month. At this time, Vertex has a average Growth Score of C, though it is lagging a lot on the Momentum Score front with an F. Charting a somewhat similar path, the stock has a grade of D on the value side, putting it in the bottom 40% for this investment strategy. Overall, the stock has an aggregate VGM Score of D. If you aren't focused on one strategy, this score is the one you should be interested in. Estimates have been broadly trending downward for the stock, and the magnitude of these revisions indicates a downward shift. Notably, Vertex has a Zacks Rank #3 (Hold). We expect an in-line return from the stock in the next few months. Vertex is part of the Zacks Medical - Biomedical and Genetics industry. Over the past month, Biogen Inc. (BIIB), a stock from the same industry, has gained 3.6%. The company reported its results for the quarter ended June 2026 more than a month ago. Biogen reported revenues of $2.74 billion in the last reported quarter, representing a year-over-year change of +3.4%. EPS of $3.60 for the same period compares with $5.47 a year ago. Biogen is expected to post earnings of $2.31 per share for the current quarter, representing a year-over-year change of -52%. Over the last 30 days, the Zacks Consensus Estimate has changed -19.4%. Biogen has a Zacks Rank #3 (Hold) based on the overall direction and magnitude of estimate revisions. Additionally, the stock has a VGM Score of C. Want the latest recommendations from Zacks Investment Research? Today, you can download 7 Best Stocks for the Next 30 Days. Click to get this free report Vertex Pharmaceuticals Incorporated (VRTX) : Free Stock Analysis Report Biogen Inc. (BIIB) : Free Stock Analysis Report This article originally published on Zacks Investment Research (zacks.com). Zacks Investment Research

ANT survey delivers a 3D subsurface view that reinforces the Robinsons River geological model and de-risks the next stage of technical work VANCOUVER, British Columbia, Aug. 18, 2026 (GLOBE NEWSWIRE) -- Vortex Energy Corp. (CSE: VRTX) (OTC: VTECF) (FSE: AA3) (“Vortex” or the “Company”) is pleased to announce the final results of the Ambient Noise Tomography (“ANT”) survey completed at the Company's 100%-owned Robinsons River Salt Project (the “Project”), located approximately 35 kilometres south of Stephenville, Newfoundland and Labrador. Further to the Company's September 16, 2025 announcement that field acquisition had been completed, the final ANT results add a 3D shear-wave velocity dataset to the geological, geophysical and drilling information being considered within the Company's ongoing staged technical review of the Project. The ANT survey successfully mapped broad subsurface velocity domains and lateral velocity changes that may reflect structural or lithological variation across the survey area. The computational model extends to approximately 3.8 kilometres and is considered to image the subsurface to at least 2.5 kilometres depth. The resulting model provides regional and structural context for the existing drilling, seismic and gravity information and is being considered as part of the Company's ongoing integrated review. However, it does not sharply or uniquely resolve the boundaries of the interpreted salt structures, likely because of overlap between the shear-wave velocities of halite and the consolidated clastic sedimentary rocks that comprise much of the local stratigraphic sequence. Accordingly, the ANT results are being used as one component of the integrated interpretation and not as a standalone method for delineating salt. 3D Shear-Wave Velocity Model The resulting shear-wave velocity model covers an area approximately 17.5 kilometres east-west by 9.24 kilometres north-south. It extends to a maximum depth of approximately 3.8 kilometres and is considered to image the subsurface to at least 2.5 kilometres depth. Modelled shear-wave velocities range from approximately 1,100 metres per second near surface to approximately 4,450 metres per second at depth. Three broad velocity domains were identified. The upper few hundred metres are generally characterized by velocities below approximately 1,500 metres per second. An intermediate, laterally variable domain extends to approximately 2.0 to 2.5 kilometres depth and generally ranges from approximately 2,000 to 4,000 metres per second. A deeper, more homogeneous domain is generally characterized by velocities above approximately 4,000 metres per second. A depth-normalized velocity-contrast model further highlights lateral velocity variation within the survey area. One of the most persistent features is a northeast-trending velocity discontinuity along the eastern part of the model that may represent a major structural or lithological boundary. Persistent higher-velocity zones along the eastern survey margin and below approximately two kilometres depth may reflect metasedimentary and granitic rocks similar to those exposed southeast of the survey area. These features remain geological interpretations of velocity variations and have not been confirmed as specific contacts or rock types. Figure 1. 3D shear-wave velocity model generated from the Robinsons River ANT survey, viewed looking north. Cool colours represent lower shear-wave velocities and warm colours represent higher shear-wave velocities. The model identifies three broad velocity domains and extends computationally to approximately 3.8 kilometres depth; CAUR concludes that the model images the subsurface to at least 2.5 kilometres depth. Source: CAUR Technologies Inc., Vortex Energy - Robinsons River Salt, CAU-25-023 - Ambient Noise Tomography Survey, Final Report. Integration with Existing Technical Information Comparison of the previously interpreted salt outlines derived from active seismic modelling with the ANT model shows that those interpretations coincide approximately with areas of lower shear-wave velocity. However, lower shear-wave velocity is not unique to salt, and the ANT results alone cannot determine the boundaries, thickness, composition or continuity of the interpreted salt structures. Because the prior outlines were used in the comparison itself, this spatial association should not be considered independent confirmation of those structures. The ANT results were also compared with the FALCON airborne gravity gradiometry data and the 3D density inversion available at the time of the analysis. This comparison showed moderate to low density variation and subtle density contrasts spatially associated with the previously interpreted salt structures. The Company is also considering the ANT velocity model alongside legacy seismic data and recent drilling information and core data within its ongoing staged technical review. Figure 2. Plan-view slices from the 3D ANT shear-wave velocity model at approximately 500, 900, 1,500 and 1,900 metres below surface. Black contours show the previously interpreted salt isopachs derived from active-seismic modelling, while solid and dashed black lines show mapped and inferred faults, respectively. The spatial association between the pre-existing salt interpretations and lower-velocity zones is approximate, and the ANT model did not independently resolve the boundaries of the interpreted salt structures. Source: CAUR Technologies Inc., Vortex Energy - Robinsons River Salt, CAU-25-023 - Ambient Noise Tomography Survey, Final Report. Ongoing Technical Review The ANT velocity and contrast models are being considered as an additional dataset within the Company's ongoing geological, geophysical and commercial review. The current stage remains focused on review and analysis of existing core and technical information, including detailed review and analysis of the VTX-24-W-02 core, representative density measurements, determination of salt percentage by volume, desktop evaluation of available information concerning source-water and disposal requirements, refinement of the integrated geological and geophysical model, and land-package optimization. "Completing the ANT survey is another meaningful step forward for Robinsons River, adding a property-scale 3D view of the subsurface to our growing body of technical data," said Paul Sparkes, Chief Executive Officer of Vortex. "By mapping broad velocity changes and highlighting potential structural and lithological boundaries, this dataset sharpens the geological framework and adds real value to our integrated interpretation. Layered together with our drilling, seismic, gravity and core data, these results give us growing confidence in the model as we advance the project through its staged technical review and work toward unlocking the full potential of this district-scale salt opportunity." Collaboration and Acknowledgements The ANT program was conducted in collaboration with the University of Alberta. Specialized survey design, instrumentation and data processing were provided by CAUR Technologies. The research collaboration was supported in part by a Mitacs grant. The Company also acknowledges the financial support of the Junior Exploration Assistance (JEA) Program, administered by the Department of Industry, Energy and Technology, Government of Newfoundland and Labrador. Qualified Person The scientific and technical content of this news release has been reviewed and approved by Jared Suchan, Ph.D., P.Geo., Vice President of Exploration of the Company and a “Qualified Person” as defined by National Instrument 43-101. The Qualified Person verified the ANT information disclosed in this news release through review of the survey documentation provided by CAUR Technologies, including the acquisition and instrument-recovery summaries, data-quality assessments, processing methodology, model outputs and interpretations. Quality-control measures included checks of instrument operating duration and recovery, assessment of cross-correlation signal-to-noise behaviour and stability, and evaluation of the dominant directional noise source from the Gulf of St. Lawrence, which was accounted for during processing and inversion. The Qualified Person did not independently reprocess the raw passive-seismic dataset or recreate the 3D inversion and has relied on CAUR for those specialist technical components. No sampling or laboratory analytical work was involved in the ANT survey. For additional information concerning the Project and the Company’s data-verification and quality-assurance procedures, readers are referred to the Company’s technical report entitled Independent Technical Report on the Robinsons River Salt Property, dated July 31, 2023, available under the Company’s profile on SEDAR+. About Vortex Energy Corp. Vortex Energy Corp. is an exploration stage company engaged principally in the acquisition, exploration, and development of mineral properties in North America. The Company is currently advancing its Robinson River Salt Project comprised of a total of 942 claims covering 23,500 hectares located approximately 35 kilometres south of the town of Stephenville in the Province of Newfoundland & Labrador. The Robinson River Salt Project is prospective for both salt and hydrogen salt cavern storage. The Company is also currently advancing its Fire Eye Uranium Property in the Athabasca Basin, a region renowned for its uranium deposits. On Behalf of the Board of Directors Paul Sparkes Chief Executive Officer, Director +1 (778) 819-0164 [email protected] Cautionary Note Regarding Forward-Looking Statements Certain statements contained in this press release constitute forward-looking information. These statements relate to future events or future performance. The use of any of the words “could”, “intend”, “expect”, “believe”, “will”, “projected”, “estimated” and similar expressions and statements relating to matters that are not historical facts are intended to identify forward-looking information and are based on the Company’s current beliefs or assumptions as to the outcome and timing of such future events. In particular, this press release contains forward-looking information relating to, among other things, the Company’s exploration plans at the Project. Various assumptions or factors are typically applied in drawing conclusions or making the forecasts or projections set out in forward-looking information, including, in respect of the forward-looking information included in this press release, assumptions regarding the Company’s ability to execute on its exploration plans, including that it will be successful in carrying out the planned drilling and that such drilling will yield the expected information and the desired outcomes. Although forward-looking information is based on the reasonable assumptions of the Company’s management, there can be no assurance that any forward-looking information will prove to be accurate. Forward-looking information involves known and unknown risks, uncertainties and other factors which may cause the actual results, performance or achievements to be materially different from any future results, performance or achievements expressed or implied by the forward-looking information. Such factors include, among other things, the risk that exploration at the Project does not proceed in the manner and on the timeline currently contemplated, or at all; risks inherent in the exploration and development of mineral deposits, including risks relating to receiving requisite permits and approvals, changes in project parameters or delays as plans continue to be redefined, that mineral exploration is inherently uncertain and that the results of mineral exploration may not be indicative of the actual geology or mineralization of a project; and that mineral exploration may be unsuccessful or fail to achieve the results anticipated by the Company, including as a result of factors beyond the Company’s control, such as geological conditions. The forward-looking information contained in this release is made as of the date hereof, and the Company not obligated to update or revise any forward-looking information, whether as a result of new information, future events or otherwise, except as required by applicable securities laws. Because of the risks, uncertainties and assumptions contained herein, investors should not place undue reliance on forward-looking information. The foregoing statements expressly qualify any forward-looking information contained herein. The Canadian Securities Exchange has not reviewed, approved, or disapproved the contents of this press release. Photos accompanying this announcement are available at: https://www.globenewswire.com/NewsRoom/AttachmentNg/fab8ba50-09f2-4a22-bfbd-5e2e1eae3663 https://www.globenewswire.com/NewsRoom/AttachmentNg/484fe765-4ea9-4930-a6b4-352edcbfec4d

Vertex Pharmaceuticals’ second quarter reflected strong commercial momentum, with management highlighting the performance of its cystic fibrosis (CF) portfolio and accelerating uptake of newer products like CASGEVY and JOURNAVX. CEO Reshma Kewalramani attributed revenue growth to “the strength of our cystic fibrosis portfolio and the growing contributions from our newer products,” while also emphasizing progress in regulatory and clinical milestones. Management specifically noted that ALYFTREK and TRIKAFTA continued to drive CF revenue, and that European launches benefitted from fewer monitoring requirements. Is now the time to buy VRTX? Find out in our full research report (it’s free). Revenue: $3.33 billion vs analyst estimates of $3.19 billion (12.5% year-on-year growth, 4.6% beat) Adjusted EPS: $4.73 vs analyst expectations of $4.75 (in line) Adjusted Operating Income: $1.42 billion vs analyst estimates of $1.37 billion (42.7% margin, 3.9% beat) The company slightly lifted its revenue guidance for the full year to $13.15 billion at the midpoint from $13.03 billion Operating Margin: 37.4%, down from 38.8% in the same quarter last year Market Capitalization: $125.7 billion While we enjoy listening to the management’s commentary, our favorite part of earnings calls is the analyst questions. Those are unscripted and can often highlight topics that management teams would rather avoid or topics where the answer is complicated. Here is what has caught our attention. Salveen Richter (Goldman Sachs): Asked about the Phase II/III OLYMPUS study dose selection for Pove in membranous nephropathy and bottlenecks in JOURNAVX’s payer dynamics. CEO Reshma Kewalramani clarified the Data Safety Monitoring Board’s role in dose selection and Duncan McKechnie highlighted ongoing efforts to secure broader access for JOURNAVX. Geoffrey Meacham (Citibank): Inquired about desired clinical outcomes for next-generation CF therapies and payer feedback on JOURNAVX in diabetic peripheral neuropathy. Kewalramani said efficacy and safety are the main goals, with further data and payer perspectives expected in coming quarters. Jessica Fye (JPMorgan): Asked about expected differentiation on eGFR endpoints for new IgAN treatments. Kewalramani explained that long-term benefits will depend on time to end-stage renal disease and the ability to achieve deeper reductions in proteinuria and hematuria. Cory Kasimov (Evercore ISI): Sought clarity on interim analysis criteria for inaxaplin in AMPLITUDE and accelerated approval. Kewalramani said the FDA agreement focuses on 1-year GFR as the primary endpoint for the interim analysis. Mohit Bansal (Wells Fargo): Queried prescription duration trends for JOURNAVX. McKechnie noted average durations have remained stable at around 10–11 days per prescription, split between hospital and retail settings. In coming quarters, the StockStory team will be watching (1) the pace of ALYFTREK adoption and label expansions in CF, (2) launch execution and patient uptake for CASGEVY and JOURNAVX, and (3) regulatory progress and launch timing for Pove in IgAN and the integration of Crinetics’ assets. Progress in clinical data readouts for next-generation CF and renal assets will also be key signposts. Vertex Pharmaceuticals currently trades at $496.00, up from $470.72 just before the earnings. At this price, is it a buy or sell? Find out in our full research report (it’s free for active Edge members). ONE MORE THING: Top 5 Growth Stocks. The biggest stock winners almost always had one thing in common before they ran. Revenue growing like crazy. Meta. CrowdStrike. Broadcom. Our AI flagged all three. They returned 315%, 314%, and 455%, respectively. Find out which 5 stocks it’s flagging this month — FREE. Get Our Top 5 Growth Stocks for Free HERE. Stocks that have made our list include now familiar names such as Nvidia (+1,460% between June 2020 and June 2025) as well as under-the-radar businesses like the once-micro-cap company Kadant (+214% between June 2020 and June 2025). Find your next big winner with StockStory today.

Image source: The Motley Fool. Monday, Aug. 3, 2026 at 4:30 p.m. ET Chief Executive Officer and President - Dr. Reshma Kewalramani Chief Operating Officer and Chief Financial Officer - Charles Wagner Chief Commercial Officer - Duncan J. McKechnie Senior Vice President of Investor Relations - Susie Lisa Operator: Good day, and welcome to the Vertex Pharmaceuticals Second Quarter 2026 Earnings Call. [Operator Instructions] Please note this event is being recorded. I would now like to turn the conference over to Ms. Susie Lisa. Please go ahead. Susie Lisa: Good evening, all. My name is Susie Lisa, and as the Senior Vice President of Investor Relations, it is my pleasure to welcome you to our Second Quarter 2026 Financial Results Conference Call. On tonight's call, making prepared remarks, we have Dr. Reshma Kewalramani, Vertex's CEO and President; Charlie Wagner, Chief Operating Officer and Chief Financial Officer; and Duncan McKechnie, Chief Commercial Officer. We recommend that you access the webcast slides as you listen to this call. The call is being recorded, and a replay will be available on our website. We will make forward-looking statements on this call that are subject to the risks and uncertainties discussed in detail in today's press release and in our filings with the Securities and Exchange Commission. These statements, including, without limitation, those regarding Vertex's marketed medicines for cystic fibrosis, sickle cell disease, beta-thalassemia and moderate-to-severe acute pain, our pipeline, the proposed acquisition of Crinetics Pharmaceuticals and the expected benefits of that transaction and Vertex's future financial performance, are based on management's current assumptions. Actual outcomes and events could differ materially. I would also note that select financial results and guidance that we will review on the call this evening are presented on a non-GAAP basis. I'll now turn the call over to Reshma. Reshma Kewalramani: Thanks, Susie. Good evening, all, and thank you for joining us on the call today. Vertex's second quarter performance was excellent, with strong momentum in the commercial portfolio, rapid progress across our R&D pipeline, and the announcement of the definitive agreement to acquire Crinetics Pharmaceuticals, which brings rare endocrine diseases as a fifth pillar to Vertex. Second quarter total revenue grew 12% year-on-year, driven by the strength of our cystic fibrosis portfolio and the growing contributions from our newer products, CASGEVY and JOURNAVX. As I've previously highlighted, this is a year of execution for Vertex across commercial, clinical and regulatory. And on each of those fronts, we advanced significantly in the second quarter. Commercially, we delivered strong revenue growth across all diseases, made meaningful progress in reimbursed access and continue to execute on near-term launch planning to drive the next phase of growth. Clinically, we continue to make significant progress in advancing our pipeline, including completing enrollment in the AGLOW Phase II study of VX-407 in ADPKD, tracking to complete enrollment in the AMPLITUDE Phase III study in AMKD by the end of this year and reporting results from the interim analysis cohort of AMPLITUDE in the beginning of 2027. We also remain on track to release results later this year from a proof-of-concept study in DM1 and an expanded population for AMKD in the AMPLIFIED trial as well as the initial patient data from VX-828 in CF. On the regulatory front, the BLA for Pove in IgAN was accepted in the U.S. with a November 30 PDUFA date. We achieved expanded labeling in record time for CASGEVY in patients ages 2 to 11 in the U.S. And I'm very pleased to share that as we continue to dose the Phase I/II/III study of zimislecel in type 1 diabetes, the IND was cleared for the blood type O islet cells in our T1D program, VX-017. We expect initiation of the VX-017 Phase I/II study in the near term. Finally, with the announced acquisition of Crinetics Pharmaceuticals, we look forward to multiple benefits of the deal, establishing a fifth pillar in rare endocrine diseases, adding to our innovative R&D pipeline, accelerating revenue growth and enhancing long-term earnings. Tonight, I'll limit my R&D comments to new news in CF, renal and type 1 diabetes and close with some additional remarks regarding the Crinetics acquisition. Let me start with CF, where we continue to extend our market leadership. Data we presented at ECFS reinforced that ALYFTREK best restores CFTR function amongst the available CFTR modulators. In particular, among children with CF under 12 years of age, the majority across all eligible genotypes achieve a sweat chloride less than 30 millimoles, which is the median among CF carriers. This is remarkable because at these sweat chloride levels, CF carriers do not exhibit manifestations of disease. In addition, we have initiated global regulatory submissions for ALYFTREK in children, ages 2 to 5. Global regulatory submissions for TRIKAFTA in patients ages 1 to 2 are also in progress. Turning to our next wave in CF and VX-828, our next-generation 3.0 CFTR modulator recently completed dosing in the patient cohort and data are expected in the second half of this year. Behind VX-828, we continue to advance additional correctors in the NextGen 3.0 family and both VX-581 and VX-272 are in healthy volunteer studies. Let me close on CF with this. Our ultimate goal has been consistent for 2-plus decades to bring patients to carrier levels of sweat chloride. Frankly, ALYFTREK's remarkable results, where nearly 2/3 of younger patients achieved sweat chloride levels less than 30 millimole per liter and for patients ages 12 plus more than 75% achieved sweat chloride levels within the carrier range of CFTR function means we are very close to that goal. Given the improvements in sweat chloride, ppFEV1, pulmonary exacerbations, hospitalizations, lung transplant and survival that we have seen in patients in clinical trials and/or the real world, we recognize that the unmet need is far lower today and the bar for any medicine to beat ALYFTREK is very, very high. Thus, as we develop our next-gen 3.0 and Beyond programs, we will evaluate multiple regimens in Phase I in cohorts of patients with CF. However, we will only advance assets into Phase II in Beyond that show promise to beat ALYFTREK. In other words, to bring even more patients to sweat chloride levels less than 30 millimoles across all genotypes with once-daily dosing and excellent drug-like properties, including drug-drug interactions. Anything less would not be competitive. Moving now to our renal franchise, where we have 4 programs in mid- and late-stage development, povetacicept in IgAN and primary membranous nephropathy, inaxaplin in APOL1-mediated kidney disease and VX-407 in ADPKD, or autosomal dominant polycystic kidney disease. Let me start with the most advanced program and significant milestone. In late May, the FDA accepted our BLA for Pove in IgAN and assigned a PDUFA date of November 30 of this year. As a reminder, the RAINIER Phase III interim analysis was a home run, delivering statistically significant and clinically meaningful results across the primary and all secondary endpoints with a favorable safety profile and consistency in the primary endpoint of change from baseline in proteinuria across all groups. We are in the final stages of launch readiness. Duncan will provide more details regarding our approach and excitement to go to market with Pove's differentiated profile of potentially best-in-class efficacy, a well-tolerated safety profile and patient-centric administration through small volume once-monthly dosing via an auto-injector at home. We are also advancing Pove internationally. We have completed the regulatory submission for accelerated approval of Pove in IgAN in Saudi Arabia, where Pove has received breakthrough designation. Turning to Pove in membranous nephropathy, our OLYMPUS Phase II/III pivotal trial is well underway. The Phase II portion is complete and the Phase III portion initiated last quarter. I'm pleased to share that the IDMC has completed its review and selected the Phase III dose, 80 milligrams subcutaneously every 4 weeks. We hold fast track, orphan drug designation and EMA PRIME designations for Pove in membranous. Stepping briefly outside of renal, on Pove in myasthenia gravis, I'm also pleased to share that the 30-patient Phase II proof-of-concept study is on track to complete enrollment by the end of this year. Recall this study evaluates 80 milligrams and 240-milligram doses of Pove versus placebo for 12 weeks. Turning now to inaxaplin in AMKD. On AMPLITUDE, our pivotal Phase II/III study in AMKD, we completed enrollment of the interim analysis cohort in September of last year and are on track to complete full enrollment by the end of this year. The interim analysis will be conducted following 48 weeks of treatment, and we remain on track to share these IA results in early 2027. If positive, we would be positioned to file for potential accelerated approval in the U.S. thereafter. AMPLIFIED is our Phase IIb basket study of inaxaplin in AMKD patients with either lower proteinuria or AMKD patients with diabetes, expanded patient populations not studied in AMPLITUDE. The AMPLIFIED study has completed enrollment and dosing and we expect to share results this fall. Lastly, in the renal portfolio is VX-407 in ADPKD, or autosomal dominant polycystic kidney disease. Our AGLOW Phase II study has completed enrollment. This is a proof-of-concept study with up to 52 weeks of treatment. We are excited about the potential for VX-407 in ADPKD and look forward to sharing more information as dosing continues and the data matures. Let me now touch on type 1 diabetes. We had very constructive meetings with the FDA following our voluntary pause in order to conduct a manufacturing analysis of zimislecel. As we shared on our Q1 call, we have resumed dosing patients in the zimislecel Phase I/II/III study. The new news today is that the FDA has cleared the IND for VX-017, our Type O or universal donor cell product. VX-017 has a similar target product profile to zimislecel, but is designed for people of all blood types and we expect the VX-017 Phase I/II study to initiate in the near term. By designing and bringing to market VX-017, another allogeneic, off-the-shelf, glucose responsive insulin producing, fully differentiated islet cell therapy, in this case, for any blood type, we anticipate doubling our market opportunity from about 60,000 to about 120,000 patients. A silver lining to the pause we took in the zimislecel Type A program is that the Type O program time differential versus zimislecel has shortened. Type O is making rapid progress. And thus, we are considering options to further streamline our regulatory strategy and commercialization approach. We expect to provide updated T1D plans, including time lines later this year. We also continue to progress our serial innovation work focused on improved immunosuppression and hypoimmune programs to make our potentially one-and-done curative therapy available to even more patients with type 1 diabetes. Let me close with a few words on our announced acquisition of Crinetics Pharmaceuticals, which we detailed in a separate call last month. Crinetics is an excellent strategic fit for Vertex with its focus on serious endocrine diseases, high unmet need, validated targets and well-understood causal biology as well as a strong people and culture fit. We believe the 2 lead assets, PALSONIFY and Atumelnant, together represent a peak sales opportunity of about $5 billion. Both are small molecules that address serious diseases for patients treated by a concentrated group of specialized endocrinologists. This fits directly within Vertex's proven, efficient, specialty commercial model. We enter this transaction from a position of strength. We view CF as a long-duration franchise with sustained growth. We continue to expect both CASGEVY and JOURNAVX to be multibillion-dollar assets and we anticipate our emerging renal franchise could one day rival CF in revenue. In addition, we have a broad and deep pipeline in earlier stages of development. The Crinetics acquisition will add to this innovation pipeline and enhance our revenue growth and long-term earnings profile by adding a fifth commercial pillar in rare endocrine diseases. The transaction is expected to close in the third quarter, and we really look forward to welcoming the talented Crinetics team to Vertex. With that, I'll turn the call over to Duncan for a commercial update. Duncan J. McKechnie: Thanks very much, Reshma. Our commercial story this quarter is one of building momentum across each of our franchises, supported by the appropriate investments to drive growth. We are very excited for the close of the Crinetics acquisition and for Vertex to establish a new pillar in specialty endocrine diseases like acromegaly, CAH and Cushing's syndrome. Crinetics Q2 results were excellent, with strong growth in PALSONIFY revenue and patients treated, but I will hold any further comments until after the deal closes. So tonight, let me start with CF. CF continues to perform very well. Global CF revenue grew 11% year-over-year in the second quarter with balanced growth across the U.S. and internationally and continued strength from both ALYFTREK and TRIKAFTA. ALYFTREK performance has been excellent and crossed another significant milestone, exceeding $1 billion in revenue in the first half of 2026. In the U.S., we continue to see patients initiating ALYFTREK who are new to therapy, returning to therapy and patients switching from TRIKAFTA. The majority of ALYFTREK revenue continues to come from these TRIKAFTA switch patients, which reflects the benefits of ALYFTREK and our success establishing ALYFTREK as the new standard of care. We're pleased with the pace at which physicians and patients are embracing ALYFTREK given its improved sweat chloride profile and once daily dosing. We've seen accelerated uptake of ALYFTREK from the recent approvals in rare mutations as well as patients rolling off our open-label extension studies. Outside the U.S., the ALYFTREK European launches remain very strong with no requirement for augmented liver monitoring in the EU, we are seeing rapid uptake by patients in Europe, transitioning from TRIKAFTA or one of our other CFTR modulators. In fact, in Germany and the U.K., more than 1 in 3 eligible CF patients are now benefiting from ALYFTREK. Globally, the CF growth drivers for the remainder of 2026 are clear: continued ALYFTREK uptake, the label expansion into rare mutations, younger patients and additional geographies. Shifting to heme and CASGEVY, where the momentum continues to build. During the second quarter, we delivered $76 million in CASGEVY revenue, reflecting approximately 75% sequential growth versus quarter 1, 2026 and over 150% year-over-year growth. This was in line with our expectations based on our visibility into patient scheduling patterns. The strength of the CASGEVY franchise continues to build. New data on CASGEVY at EHA with simultaneous publication in the New England Journal of Medicine demonstrated its transformative potential in pediatric patients as well as durable benefits, reinforcing the importance of early intervention to prevent the complications of sickle cell disease and beta thalassemia in children. Stemming from this compelling data, last month CASGEVY became the first and only gene therapy FDA approved to treat children as young as 2 years old in both sickle cell disease and beta thalassemia. CASGEVY received supplemental approval in the U.S. in a record 53 days post-filing, and our first pediatric patient has already initiated therapy and conducted cell collection. Outside the U.S., CASGEVY regulatory submissions in the 5 to 11 age group are now complete in Saudi Arabia and the United Kingdom. On the reimbursement front, we are seeing strong trends in initiations in Germany after reaching a historic reimbursement agreement there as well as continued strong uptake in the U.K., Italy and the Middle East following the negotiations of sustainable access agreements. The CASGEVY story continues to be one of an increasingly robust pipeline of patients initiating the treatment journey. There were more CASGEVY infusions in the first half of 2026 than in all of 2025. Second quarter 2026 was also the third sequential quarter with more than 100 patient initiations, which enhances our visibility to continued growth for the rest of this year and early 2027 as patients continue to move through cell collection, editing and infusion. Quarter-to-quarter variability in CASGEVY revenue will continue and reflects the timing of patient infusions as people choose to receive their infusions when it best suits them. As we look forward, we expect continued CASGEVY momentum with the pipeline of patients at every stage continuing to build. CASGEVY is well positioned to contribute meaningfully to our $500 million non-CF revenue goal this year and to achieve its stand-alone multibillion-dollar potential. Turning to JOURNAVX in moderate-to-severe acute pain, where our launch continues to gain traction. In the second quarter, JOURNAVX generated $50 million in revenue, reflecting sequential revenue growth of approximately 70% and sequential prescription growth of approximately 45% versus quarter 1, 2026. Unpacking Q2 performance, revenue was positively impacted by channel build after we've seen a drawdown in quarter 1. At this stage in an acute product launch, we continue to expect some quarterly volatility in inventory build and drawdown as full-line wholesalers and retail channel buying patterns normalize to reflect formulary adoption, physician awareness and seasonality in elective surgeries. We are building a pain franchise for the long term and are focused on the following 4 critical markers of success: prescription growth, breadth and depth of prescribers, the addition of JOURNAVX to hospital and IDN pathways and broad payer coverage. These are the building blocks of a sustainable, long-term, multibillion-dollar business. We are extremely pleased with the prescription growth we continue to build, which is ahead of our forecast for 2026. The breadth and depth of prescriptions across a wide range of settings of care as well as the clinical impact of JOURNAVX continue to be very strong and all bode well for the long-term growth of JOURNAVX in acute pain. The consequence of this rapid prescription growth is that we are seeing greater use of the PSP program than we forecast as securing unrestricted payer access and physician education catches up with prescription growth. Let me break down what I mean by that. At this point, we have a total of 260 million lives covered out of a total possible of approximately 320 million. Of the 260 million covered lives, 180 million of them have unrestricted coverage. This means that there are 60 million lives yet to be covered and about 80 million lives who have coverage, but with some form of restriction, making some of them eligible for the PSP program. These restrictions are usually very minor in nature, such as a 14-day quantity limit or a prior authorization to indication. As we continue to educate physicians and their office staff about the quantity limits and prior authorizations, we expect the PSP to be triggered less frequently and therefore, more revenue to be recognized. Let me now provide you with some more details on prescriptions, prescribers and access before concluding our thinking on the PSP program and gross-to-net. In terms of prescriptions, quarter 2, 2026 JOURNAVX prescriptions totaled approximately 535,000 and just over 900,000 for the first half of 2026. The prescriptions continue to be split roughly 50-50 between the hospital and retail channels. In both channels, monthly prescriptions were approximately 50,000 in January and doubled to approximately 100,000 in each channel in June. In terms of prescribers, we added approximately 18,000 new HCP prescribers to JOURNAVX in Q2 '26 and are pleased that JOURNAVX is now on 1,400 hospital and 130 IDN pathways in terms of formulary, protocol or order sets. These are important metrics as we seek to convert practices and continue to embed the use of JOURNAVX among our target physicians. We've also made further progress with respect to access. We recently signed agreements to expand reimbursed access to JOURNAVX with 2 additional Medicare Part D plans, effective from July 1. With these additions, 3 of the big 4 Medicare Part D plans now provide covered access alongside the 3 large commercial PBMs. As mentioned, this brings the total covered lives for JOURNAVX to approximately 260 million out of a total possible of 320 million and within that, approximately 180 million lives with unrestricted access. Our goal continues to be to ensure the prescribing experience for physicians and patients is as seamless as possible in a market where the delivery of the medicine is highly time-sensitive. We will continue to work to educate physicians to navigate the minimal quantity limits and prior authorizations that exist and secure ever broader coverage. In the meantime, we will maintain the PSP program so that patients who are prescribed JOURNAVX can get it. We continue to see this as a strategic choice as we seek to convert physician practices away from decades of reliance on opioids to ongoing and sustained use of JOURNAVX for many years to come. As a result, we continue to expect gross to net to normalize in line with other branded oral medicines, but now in the first half of 2027. To conclude on pain, we also continue to be on track to exceed our goal of more than tripling the 550,000 prescriptions and more than tripling revenue from 2025 into 2026 as well as delivering more than $500 million in revenue from CASGEVY and JOURNAVX combined in 2026. Let me conclude with an update on our commercial readiness in renal and specifically Pove in IgAN. With the FDA's acceptance of our BLA and the November 30 PDUFA date, we are in the final stages of commercial launch preparation. We're investing in our renal franchise and the nephrology community for the long term, given our innovative pipeline of multiple potentially transformative kidney disease medications that address the underlying causes of serious renal conditions. Our goal is for Pove to be physicians' first choice among disease-modifying therapies for IgAN and we know from our market research and from nephrologist feedback that physicians are looking for treatments that meaningfully and rapidly reduce proteinuria, have a favorable tolerability profile and offer a seamless treatment experience from access through patient support to convenient dosing. We believe Pove has the winning trifecta of efficacy, tolerability and ease of use for patients and physicians alike. With dual BAFF + APRIL inhibition, Pove has clear best-in-class potential and delivers effectively on all the needs we've heard from the community in research and advisory boards making it the ideal first choice after baseline therapy with ACEi, ARBs and SGLT2s. We have completed the hiring of our renal field force of whom about 90% have nephrology experience and was built with the breadth of our renal pipeline in mind. We anticipate that we will have the largest field force among the novel APRIL or APRIL + BAFF therapies for IgAN. Our payer conversations are also proceeding well. In the U.S., approximately 70% of patients with IgAN have commercial coverage. From our engagements with payers, their awareness of IgAN and the new BAFF + APRIL inhibitors is high. Payers understand the unmet need, have a good understanding of the KDIGO guidelines and how the new therapies fit into treatment pathways. Payers are also very aware of the strength of the Pove Phase III interim analysis data and Pove's November 30 PDUFA date. Our market access teams continue to actively engage with payers to prepare for the upcoming launch of Pove. Additionally, we will provide robust patient support programs drawing on our decades of experience in CF. Pove in IgAN is the first component of our emerging renal franchise, and we're excited to bring it to nephrologists and to their patients. We believe Pove's trifecta of efficacy, tolerability and ease of use delivers exactly what nephrologists are seeking. And just as we've done for over a decade in CF, Pove's success will be driven by a field force delivering a high-science sell, fueled by a potentially best-in-class product, broad reimbursement and robust high-quality patient programs. We are very excited to commercialize Pove in IgAN and begin building a multibillion-dollar renal franchise at Vertex. I'll now turn the call over to Charlie to review the financials. Charles Wagner: Thanks, Duncan. As Reshma noted, Vertex's second quarter results demonstrate our consistent strong performance and attractive growth profile. Second quarter 2026 total revenue of $3.3 billion increased 12% year-over-year with growth balanced between the U.S. and international markets. As expected, Q2 2026 revenue growth reflects an approximate 170 basis point benefit from foreign exchange rates. Q2 '26 Global CF revenue grew 11% year-over-year, and new disease areas also contributed with CASGEVY delivering $76 million compared to $30 million in Q2 of 2025 and JOURNAVX revenue of $50 million compared to $12 million in Q2 of 2025. As a reminder, Q2 '25 results also included $21 million of collaboration revenue. Q2 '26 U.S. CF revenue grew 9% year-over-year, led by strong volume growth from ALYFTREK uptake, continued performance from TRIKAFTA and higher realized net price. Outside the U.S., CF revenue grew 12% year-over-year, driven by strong ALYFTREK launches, timing of orders in certain geographies as well as the benefit from FX. Note that global CF revenue growth for the first half of 2026 was 8%, including the benefit of prior year U.S. price increases and foreign exchange. We expect both of these factors to contribute less to growth in the second half of the year. Our second quarter 2026 gross margin was 85.6%, an expected sequential step-down from Q1 of '26. This step down reflects the impact of product mix as well as manufacturing network investments in various products. As our new products, particularly CASGEVY, increase in revenue contribution with higher cost of goods sold than our small-molecule CF products, we continue to expect full year gross margin of just under 86%, roughly in line with this quarter's result. The impact from product mix and manufacturing network investment costs will be more pronounced in the second half than they were in the first half of 2026. Turning to operating expenses. We continue to invest appropriately given the attractive opportunity presented by our ongoing and near-term launches as well as our attractive mid- and late-stage pipeline. Second quarter non-GAAP R&D expense of $889 million increased 1% year-over-year with steady progress across multiple Phase III studies and the earlier-stage pipeline. Non-GAAP SG&A expense of $520 million increased 45% year-over-year, driven primarily by commercial investment split roughly evenly between pain and renal. We also recorded $21 million in acquired IPR&D expense in the quarter. Note that while R&D continues to account for nearly 2/3 of our operating expenses, the modest growth rate reflects that we are in a period where we can redeploy dollars from programs that wind down to fund programs that are new or scaling up. In contrast, much of our commercial spending is to build new businesses and thus is incremental, as reflected in the higher year-over-year growth rates when compared to R&D spending. Our second quarter 2026 non-GAAP effective tax rate was 21.1%, including some one-time expenses. Year-to-date, our non-GAAP effective tax rate was 20.4%, within our guidance range of 19.5% to 20.5%. Our second quarter 2026 non-GAAP earnings per share of $4.73 represents 5% growth versus prior year, reflecting strong revenue growth as well as investments in our pipeline and commercial capabilities. Turning to the balance sheet. We ended the quarter with approximately $13.6 billion in cash and investments. During the second quarter, we deployed approximately $455 million to repurchase roughly 1 million shares. This activity reflects our ongoing commitment to returning value to shareholders while maintaining the flexibility to act on strategic growth opportunities. Of course, our top priority for capital deployment remains investing in innovation as evidenced by our recent announcement to acquire Crinetics for approximately $8.8 billion net of cash acquired. Now turning to guidance. Given our strong first half performance and the momentum across the business, we are raising our full year 2026 total revenue guidance to a range of $13.1 billion to $13.2 billion, 2026 revenue guidance reflects continued strong performance from the CF franchise, including ALYFTREK and TRIKAFTA as well as growing year-over-year contributions from CASGEVY and JOURNAVX. We continue to expect revenue of $500 million or greater from our non-CF products, and our outlook also continues to include an expected 150 basis point benefit from foreign exchange net of our hedging program. As I previously mentioned, we continue to expect full year gross margin of just under 86%. On operating expenses, we are reiterating our combined non-GAAP operating expense guidance of $5.65 billion to $5.75 billion, though we now expect to be at the high end of that range. This reflects continued investment in our late-stage clinical pipeline and the commercial infrastructure and activities that support our new launches and revenue diversification. We continue to expect our non-GAAP effective tax rate to be in the range of 19.5% to 20.5% for the full year 2026. I would note that today's guidance does not yet reflect the pending Crinetics acquisition, which is expected to close in the third quarter. Given the anticipated timing, we expect the impact to 2026 revenue and non-GAAP operating expenses to be relatively modest, and we will provide updated guidance for 2026 around the time of closing. As a reminder, we expect to fund the transaction through a combination of cash on hand and proceeds from a $4.5 billion term loan, and we expect the transaction to become accretive to non-GAAP operating income in 2029. In summary, Vertex delivered strong second quarter results. Our commercial launches and diversification are gaining momentum, and we continue to invest with discipline in both innovation and commercialization. Overall, our financial performance and outlook remain compelling, with expanding CF leadership, heme and pain scaling, renal on the doorstep of launch and the addition of a fifth pillar in specialty endocrine through the pending Crinetics acquisition, Vertex is exceptionally well positioned for continued growth. Our high success rate in R&D and our disciplined specialty commercial model allow us to maintain industry-leading margins even as we step up investments to support our launches and pipeline. With this unique profile, we are well positioned to continue expanding our impact for patients, investors and all stakeholders. We look forward to updating you on our continued progress across multiple disease areas with key upcoming milestones detailed on Slide 19. I'll now ask Susie to begin the Q&A period. Operator: [Operator Instructions] And our first question for today will come from Salveen Richter with Goldman Sachs. Salveen Richter: Two for me. One is you announced that the Phase II/III OLYMPUS study for Pove in pMN is going to move to Phase III with an 80-milligram dose every 4 weeks. Can you frame what signal this was based on and whether you or the DSMB or what you or the DSMB saw on the Phase IIb portion to move forward? And then on the pain front, it was really nice to see the progress here. Maybe help us understand where the bottlenecks lie now or what needs to be worked on with regard to formulary as well as the payer dynamics as you look at co-pay, et cetera. Reshma Kewalramani: Sure thing, Salveen. Let me kick us off with the first question, which is about Pove in membranous. The Phase II is complete, the Phase III was already initiated, you might recall, a couple of months ago as we designed it as a seamless Phase II/III. The DSMB was asked to base their decision and it was their decision because we do not have access to the unblinded data to look at on efficacy PLA2R, which is the biomarker equivalent in membranous as Gd-IgA1 is to IgAN. Of course, they had full access to the safety results as they made their decision. I suppose in many ways, it's not surprising that they picked the 80-milligram dose given the RUBY-3 results, where you could see that the 80 milligrams had a very nice reduction in PLA2R, but that's how the decision was made. Study is well on its Phase III portion, and we look forward to getting that study enrolled and completed. Duncan, I'm going to turn it over to you for a little commentary on JOURNAVX scripts and what more we're working on. Duncan J. McKechnie: Salveen, so as you know, our goal with JOURNAVX is to fundamentally transform how pain is treated and to move physician practices away from decades of reliance on opioids. In terms of our progress, we're very pleased with the prescription numbers that we're seeing. We are also very pleased with the increased number of hospitals that have adopted JOURNAVX, now 1,400 or so with 130 IDNs, having it on formularies and we have also now secured 2 additional Medicare Part D plans to cover JOURNAVX starting from July 1. So overall, our progress is very well and going very well. And I would add that those prescriptions are coming from a broad range of physician types and being used in a broad range of pain types consistent with our label. In terms of the payer side and access, we're very pleased with the coverage that we've secured to date, 200 -- 260 million lives, and that's ahead of those 2 Medicare Part D plans coming in. And I would say we have obviously more work to do to secure the final elements of access for JOURNAVX. And we also have to make sure that those patients whose physicians might have, say, a quantity limit are able to navigate that in order to ensure the patient can secure access. In the meantime, we have the PSP program in place and anticipate that we'll continue to see prescriptions transition to increasing growth in revenue in the second half of 2026. And indeed, as we've communicated before that our gross to net will ultimately normalize at the same level as our oral branded medicines in the pharmaceutical arena. So we're very happy with the progress. We have a little bit more work to do, but we are very happy with where we're at right now in terms of physician adoption, payer coverage and hospital usage. Operator: The next question will come from Geoff Meacham with Citibank. Geoffrey Meacham: Have 2 quick ones. The first one is CF on 828 or the other assets in Phase I, what are some of the clinical attributes you're looking for? I wasn't sure if you're looking for perhaps a not only better treatment effect or if there is a potential to not need liver monitoring, for example, in future combos. Second question on JOURNAVX. You guys have had substantial discussions with payers, hospital systems, physicians on acute pain. But in these conversations, have you gotten any perspectives or context on DPN like what the clinical profile needs to show as we look to the data end of the year, beginning of next year, what the access and reimbursement could look like in this setting? Reshma Kewalramani: Sure thing, Geoff. Let me take the second question first. On JOURNAVX, we have been hyper-focused on JOURNAVX in acute pain to make sure that we get all of those reimbursement contracts done and get access. So I think it would be just very fair to say, we've spent all of our time hyper focused on acute pain. We'll have more to say on where we are with DPN, the data, what payers are looking for, what doctors are looking for, et cetera, in the coming months. But for here and now, it's acute pain. On VX-828 and the next-gen molecule, so just to give you all of the numbers, VX-828 is the first of the next-gen. The second and third are 581, VX-581 and VX-272. We are looking for potential improvement in efficacy, i.e., more people who can get down to less than 30 millimoles. And of course, we're looking for safety as well. So the monitoring will depend on what the results in the clinical trial are. So sure, there's opportunity for monitoring to be different with this VX-828 program. It just depends on what the actual results are through the clinical trial program. Last thing to say, once daily dosing, really good-looking DDIs as well as other drug-like properties remain really important as I mentioned in my prepared remarks. Operator: The next question will come from Jessica Fye with JPMorgan. Jessica Fye: Maybe for Reshma. I'm curious if you expect to see material differentiation on eGFR across the new IgAN products like Pove and its competitors? And if so, over what time horizon do you think any differentiation on that endpoint would become apparent? Reshma Kewalramani: Sure thing, Jess. As we've discussed before, in IgAN in particular, but you could say this for homogeneous proteinuric kidney diseases in general. Good reductions in proteinuria should, based on everything we know, result in stabilization of GFR. I expect that to be the case with APRIL-BAFF inhibitors as well. I think so that your question is asking a very important second point. And to me, the most important point. What is the differentiation we can expect between various molecules if you have more reduction in proteinuria or hematuria or in the case of IgA nephropathy, Gd-IgA1, these inciting antibodies. And I think for that, the answer is it's really about time to ESRD. That's to say time to dialysis, transplantation or death. And I do expect that the medicine that has the stronger reductions in proteinuria, the medicine that gets more patients to less than 0.5 or 0.3, better improvements in hematuria and Gd-IgA1 are more likely to have an improved profile when it comes to that ultimate endpoint. Proteinuria, 1-year GFR, 2-year GFR, these are all endpoints on the way to the ultimate endpoint. And I think that's where you'll see the real differentiation. Operator: The next question will come from Cory Kasimov with Evercore ISI. Cory Kasimov: Wanted to ask about inaxaplin in the AMPLITUDE study? And what kind of data would be necessary in that interim analysis to file for accelerated approval? Basically, like what constitutes the win with this first data look. Reshma Kewalramani: Sure thing. Cory, I think you're asking about AMPLITUDE. So the core study that's now in Phase III in patients with 2 APOL1 alleles, moderate-to-heavy proteinuria and depressed GFR. We were really pleased and remain very pleased that the agency has provided and we have an agreement with the agency for a potential accelerated approval based on the primary endpoint at the time of the IA, which is 1 year GFR. So that's what our agreement is based on. Obviously, we're also going to look at the proteinuria, but the agreement with the agency for the potential to file for accelerated approval based on the interim analysis is 1-year GFR. Operator: Next question will come from Brian Abrahams with RBC Capital Markets. Brian Abrahams: Congrats on the quarter. On pain, we've seen some data published recently from another NaV1.8. And I'm just curious how you see the acute pain dynamics playing out with additional entrants into the market potentially? And then secondarily, just on zimi. Just wondering if you could talk about the potential impact to launch timing if you do end up syncing the filing with VX-017. Reshma Kewalramani: Yes. Thanks for the kind words, Brian. Maybe I'll do the pain one first and then come on to type 1 diabetes. I did see the publication. And maybe, Brian, what I'd say is that ever since Vertex published VX-150, which you'll remember was the molecule circa 2017 or so. We saw a spike in others following our footsteps and pursuing NaV1.8 as a target. And what I'll say is that we decided not to advance 150 -- VX-150 because we didn't think it had, as I described at the time, the perfect drug-like molecule, properties that we were looking for and we bypassed 150 in favor of what is now suzetrigine or VX-548. So we know the space very well. We know the molecule well, and we know that every time we publish a patent, there is a slew of followers. Maybe if you say, well, what's the takeaway from that, I think that there is a high appetite in the biopharma industry to make nonopioids. There is high unmet need for non-opioid effective pain medicines that have not only the right efficacy, but the right safety tolerability, drug-like properties profile. And I really like where we are well on the market with JOURNAVX, and I'm very much looking forward to the possibility of NaV1.7/NaV1.8 combination. And I've never felt better in Vertex history for the fact that may come to pass for us to be able to bring that to the clinic. Switching then to the type 1 diabetes program. So let me just say what I said in my prepared remarks. I may have gotten a little quick there. The zimislecel program is in Phase I/II/III, back up in dosing. And because it's a type A program, it serves about 60,000 people in the U.S. and Europe. The 017 program because it is Type O, has the potential to serve 120,000 people because it's the universal donor type O. And now what we're trying to do is see if we can get the type O program to go even faster and bring that program out either first or very close behind. That's what we're working on in terms of both the regulatory approach and the commercial approach. I don't have a time line for you today, but we should be able to tell you our exact plans with time lines in the back half of this year. But I am very excited about the opportunity to perhaps bring type O out first or very, very close behind. Operator: Your next question will come from Evan Seigerman with BMO. Evan Seigerman: Congrats on the progress, so you've maintained the expectation for at least $500 million of non-CF revenue this year, while CASGEVY and JOURNAVX delivered roughly $125 million this quarter. So as you think about the path to this target, should we expect that the majority of the upside comes from accelerating patient starts with CASGEVY, continued growth with JOURNAVX or kind of a relatively balanced contribution from both franchises. Reshma Kewalramani: Evan, I'll ask Charlie, if he wants to make any additional comments on our guidance on the $500 million. Charles Wagner: Yes, Evan, thanks. As you pointed out, so far in the first half of the year, CASGEVY and JOURNAVX combined delivered about $200 million in revenue. So we're well on our way to achieving our target of $500 million-plus in that first half. CASGEVY has been a bigger contributor than JOURNAVX, but I'm not willing to give further color on the balance of the year other than to say we're very confident in getting to that $500 million plus. Operator: The next question will come from Michael Yee with UBS. Michael Yee: I guess the IgAN competitor data to your eGFR data is hot off the press, and it's out there on the tape, and you can see that the approved product has essentially a stabilization of eGFR, if not slightly above the baseline. So to what extent Reshma, given that you have an approval coming up soon, should we think about comparing the 2, either from a launch perspective or perhaps given the strong numbers that they're putting up, it speaks to the significant market opportunity and you can get equivalent share? Maybe just talk a little bit about the data that the competitor is putting up and how you think about your launch? Reshma Kewalramani: Sure thing. Mike, the -- I did just see the eGFR data, but I've just seen the top-line number. And as you say, it shows a stabilization right around 0. That is what we should expect given the proteinuria reduction. So that seems very much in line. With regard to what it means for the povetacicept IgAN program, I would say all the more reason if anybody needed a little bit more conviction, you can certainly look at these data that were presented today, look at the proteinuria reduction, look at the GFR and reconfirm for yourself that significant reductions in proteinuria should and have resulted in GFR stabilization. So it makes a lot of sense to me. For what I see for Pove, I see us putting up very strong numbers on proteinuria, numerically, the best out there, 52% change from baseline in terms of proteinuria reduction, 70-plus percent reductions in hematuria and 70-plus percent reductions in Gd-IgA1. That bodes very well for Pove. And then I'll emphasize, Mike, the patient-centric attributes of delivery once-monthly, small-volume, 0.46 ml via an auto-injector. And I think when you put all of that together, real excitement for me for what Pove may bring to patients once the PDUFA date comes and goes, and we have the opportunity to launch. Operator: The next question will come from Tazeen Ahmad with Bank of America. Tazeen Ahmad: Are you still planning on presenting additional data from the RAINIER study this year? And if so, what level of data? And where could that be? And then secondly, for Pove in gMG, it's becoming an increasingly competitive space. So how are you thinking about what additional benefit your drug could provide into this space either with efficacy, safety or dosing frequency? Reshma Kewalramani: Yes, on RAINIER. We are planning to present data. The conferences don't like it when we suggest the name when submissions have been made, but acceptances haven't come through yet. So maybe I'll just leave it at, yes, we plan to present the full RAINIER IA data set. We're looking forward to do so. I'll say at a fall conference, and I'll leave it to your imagination for which one. On gMG and Pove, this one is really exciting. And you gave me 3 options for why we're excited about Pove in gMG: efficacy, safety or patient benefits administration, all 3. This is another one of those trifectas that Duncan has talked about. On efficacy, there is another molecule, a wild-type TACI, so not engineered for optimal potency, binding affinity or tissue distribution. That has already shown substantial efficacy benefit. And remember, that's a wild-type TACI compared to Pove, which is an engineered TACI. So that's on efficacy. On safety, Pove does not need to have a cycle on and a cycle off. That gives real benefit on safety, but that also has the secondary benefit on efficacy because you don't have that off period where the autoantibodies are allowed to return. And the third is same thing, auto-injector. We have to figure out whether it's the 80 milligrams or 240 milligrams, but in either case, it will be auto-injector, once-monthly at-home low-volume dosing. So of your options, I expect Pove to be better across the board on all 3 dimensions. Operator: The next question will come from Philip Nadeau with TD Cowen. Philip Nadeau: There's a lot of focus on the upcoming data from one of your competitors where we're going to get incremental sweat chloride reductions above TRIKAFTA. We're curious to hear Vertex's opinion on how you're going to interpret that data? Is there a level of sweat chloride reduction that would get your attention or Reshma, as you've suggested in the prepared remarks, is it more about simply the proportion of patients who get to less than 30 millimoles per liter and the exact reduction maybe isn't as meaningful because it can be influenced by things like baseline characteristics? Reshma Kewalramani: Yes. Phil, I think you have it right on our perspective. Where we sit today with ALYFTREK. We already know we can get 2/3 of patients to less than 30 millimoles. That's that normal or carrier threshold. And furthermore, if you think about as all physiologic parameters do, there is a Gaussian distribution around that median sweat chloride 30 millimoles. If you superimpose across all age groups, the ALYFTREK data on the carrier data, more than 75% of people across age groups overlap that distribution. So with those kind of data, I think that the bar is exceptionally high and rests on getting more patients to less than 30 millimoles. That is the mark and that's the mark that we or anyone else has to hit in order to have a competitive medicine. And of course, it goes without saying it has to be safe, it has to be well tolerated. It has to have good DDIs, it has to be once daily. But on pure efficacy, it has to be a molecule that gets more patients to less than 30 millimoles in terms of sweat chloride. Operator: The next question will come from Terence Flynn with Morgan Stanley. Terence Flynn: I have another one on inaxaplin. I was just wondering if you can help set expectations for the upcoming AMPLIFIED Phase II trial? And then how to think about any read-through to AMPLITUDE? Reshma Kewalramani: Yes. So AMPLIFIED is the study that's Phase II. It's the expanded AMKD population. By that, I mean, it's the population with 2 APOL1 alleles. And in one arm of the basket study, it's 2 APOL1 alleles diabetes and in the other arm, it's 2 APOL1 alleles, and let's call it, modest proteinuria, so low-grade proteinuria. The way I would frame it up is the study is completed. We are on track for us to be able to share results this fall. And what I'd be looking for and looking to understand is can we derive benefit on proteinuria when you have very modest proteinuria to start with. So this is 0.2 grams to 0.7 grams of protein as opposed to 0.7 grams and above. And of course, it all comes down to what the mean entry baseline level of protein is. Or in the case of diabetes, can we alter the proteinuria when you have second kidney disease involved. These are questions worth studying, but there are clearly different populations than AMPLITUDE, which is why we specifically did not include them in the Phase II original study of inaxaplin and equally why we didn't include them in the Phase III study called AMPLITUDE. So we're super excited to look at these results. We're going to learn a lot and I'm very, very, very happy, and I think you'll see the wisdom of our approach, given what has happened in the field for others to keep these populations, which are expanded populations separate and look at each one individually in this basket AMPLIFIED study. Operator: The next question will come from Mohit Bansal with Wells Fargo. Mohit Bansal: Just maybe a question for Duncan, if you want to help with the prescription trends here for JOURNAVX, so obviously, prescription growth is very strong. But how should we think about the prescribing behavior in terms of how many days of therapy physicians are writing? Has it changed at all in last few quarters or so because it does seem like you have good access, you have good prescription, but probably -- this is probably a missing piece, which could improve here. Duncan J. McKechnie: To answer your question specifically, as I think we've communicated before, in hospitals, the prescription duration is around about 5 days or so. In retail, it's around about 12, 14 days. So on average, you net out at around about 10 or 11 days or so for each JOURNAVX prescription. And candidly, that dynamic has not changed since the launch because it's really driven by the dynamics of the institution that the patient is in rather than anything else. So to answer your question simply, those are the numbers, and it has not changed over the last few months. Operator: The last question will come from Ellie Merle with Barclays. Eliana Merle: So in terms of the DM1 program, what would be good data at the data update in the second half? And how are you thinking about it in the context of the broader competitive landscape in DM1? Reshma Kewalramani: Sure, Ellie. Maybe I can take that one. In DM1, as you know, there hasn't been a clear correlation between the various endpoints that others in the field have looked at, albeit with different approaches. What people have tended to do in their Phase II studies to get an early read is look at splicing, a functional endpoint called vHOT and another functional endpoint called QMT, vHOT is sort of how long does it take to open/close your hand and QMT is a measure of muscle function. And what I would say is that of all of those, splicing is an important one, and we certainly are looking at splicing and these measures of muscle function are also something that we're looking at. The reason I like this approach compared to anything else has more to do with mechanism of action. And that has to do with the fact that it's an oligo, which others are also trying but it's an oligo linked to a circular peptide to a nuclear localizing domain peptide which we believe will allow it to get into the cell and get into the nucleus where it has to do its work. So that is a plus. And I would also say some of the other programs in order to get into the cell have used mechanisms that have some safety tolerability concerns, and that has not been a concern through the circular peptide program that we use. So for the efficacy endpoints in Phase II splicing, and we will also look at these QMT and vHOT endpoints, albeit in small numbers of patients. Operator: And that will conclude our question-and-answer session as well as our conference call for today. Thank you for your participation. A replay will be available shortly after the call concludes by dialing 1 (855) 669-9658 or 1 (412) 317-0088 using replay access code 10208186. Thank you for attending today's presentation. You may now disconnect. Ever feel like you missed the boat in buying the most successful stocks? Then you’ll want to hear this. On rare occasions, our expert team of analysts issues a “Double Down” stock recommendation for companies that they think are about to pop. If you’re worried you’ve already missed your chance to invest, now is the best time to buy before it’s too late. And the numbers speak for themselves: Nvidia: if you invested $1,000 when we doubled down in 2009, you’d have $581,599!* Apple: if you invested $1,000 when we doubled down in 2008, you’d have $59,719!* Netflix: if you invested $1,000 when we doubled down in 2004, you’d have $399,832!* Right now, we’re issuing “Double Down” alerts for three incredible companies, available when you join Stock Advisor, and there may not be another chance like this anytime soon. See the 3 stocks » *Stock Advisor returns as of August 3, 2026 This article is a transcript of this conference call produced for The Motley Fool. While we strive for our Foolish Best, there may be errors, omissions, or inaccuracies in this transcript. As with all our articles, The Motley Fool does not assume any responsibility for your use of this content, and we strongly encourage you to do your own research, including listening to the call yourself and reading the company's SEC filings. 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This article first appeared on GuruFocus. Release Date: August 05, 2026 For the complete transcript of the earnings call, please refer to the full earnings call transcript. AbCellera Biologics Inc (NASDAQ:ABCL) completed enrollment for the phase 2 study of ABCL-635 in treating hot flashes well ahead of schedule, with a top-line data readout expected very soon. The company has secured significant new business development deals, including T-cell engager collaborations with Vertex and Jazz Pharmaceuticals, adding over $110 million in upfront cash. AbCellera Biologics Inc (NASDAQ:ABCL) maintains a strong liquidity position with over $565 million in cash and equivalents, plus roughly $110 million in committed government funding, providing a runway of at least three years. The phase 1 data for ABCL-635 showed robust and sustained target engagement with a clean safety profile, including no perceptible increase in liver enzymes, which could be a key differentiator from existing small molecule treatments. The company's T-cell engager platform has matured over five years, now including diverse CD3 binders, co-stimulatory antibodies, and scalable workflows, positioning it as a key asset for strategic partnerships. AbCellera Biologics Inc (NASDAQ:ABCL) added two experienced independent directors to its board, bringing complementary expertise in oncology, women's health, immunology, and endocrinology. AbCellera Biologics Inc (NASDAQ:ABCL) reported a net loss of roughly $55 million for Q2 2026, a significant increase from the $35 million loss in the same quarter of 2025. Total revenue for the quarter dropped to approximately $4 million, down from $17 million in the prior year quarter, reflecting a decline in partnership revenue. The company missed its internal goal of moving another program into IND-enabling activities in the first half of 2026, indicating potential delays in pipeline advancement. Research and development expenses increased by approximately $7 million year-over-year, reflecting higher investment in internal programs and putting pressure on the bottom line. The upcoming phase 2 data for ABCL-635 carries key scientific risks, including the unresolved question of whether blocking NK3R in the pre-optic nucleus is necessary for efficacy, which could impact the drug's potential. The company acknowledged a pronounced placebo response in similar trials, which could affect the perceived efficacy of ABCL-635 in the upcoming readout. Warning! GuruFocus has detected 3 Warning Signs with ABCL. Is ABCL fairly valued? Test your thesis with our free DCF calculator. Q: What is your view on a clinically meaningful improvement in VMS severity, and will threshold analysis for VMS frequency data (e.g., proportion of patients with 90% or 100% reduction) be included with the top-line data?A: Carl Hansen (President and CEO): Success is defined by a clean safety profile, consistent with phase 1 data, and efficacy comparable to approved small molecules. On frequency, we are looking for at least a 20% response relative to placebo, with a reduction of at least 2 hot flashes per day. On severity, we expect it to track with frequency and be comparable to small molecules, though we haven't set a definitive bar. Historically, severity is easier to hit than frequency, so our focus is on the frequency side. Q: Why not move directly into phase 3 label-enabling studies in cancer indications (e.g., breast cancer or men on androgen deprivation therapy) instead of starting with phase 2 studies?A: Carl Hansen (President and CEO): Moving first into the oncology patient population, which is significantly different, is the necessary first step before later-stage trials. We expect to initiate this relatively soon as we prepare for the larger study on VMS associated with menopause. There will be a gap between the readout and finalizing the trial setup, so we are sequencing as quickly as possible. Q: If the upcoming data confirms a clean liver profile for ABCL-635, what are your plans for phase 3 liver monitoring to establish definitive differentiation, and could this capture the first-line non-hormonal market?A: Carl Hansen (President and CEO): Safety is a key differentiator. Both approved small molecules require liver monitoring, which is inconvenient. We believe this is associated with small molecule metabolism and not expected with an antibody. Phase 1 data showed no perceptible increase in liver enzymes. We will continue monitoring enzyme levels, but scientifically, there is no reason to expect issues. Additionally, the small molecule has a somnolence side effect linked to NK1R binding, while our antibody is entirely specific to NK3R, so we don't expect that. Improved safety and once-monthly dosing are paramount for this product. Q: Can you discuss the percentage of internal resources dedicated to the TCE platform versus other platforms like GPCR and ion channels?A: Carl Hansen (President and CEO): Our TCE work is a longstanding effort, with the last 5 years spent building the foundation. Much of that work is now in the bank, giving us extra bandwidth to take on additional programs. There won't be a big change in resource allocation to TCE, but it will shift from building capabilities to executing on them for internal and partner programs. While I don't have a hard number, significantly more effort is on the GPCR and ion channel side, but TCE remains a strong pillar of the pipeline. Q: Looking at historical data for elinzanetant and fezolinetant, it seems severity may be exposure-driven. How are you thinking about ABCL-635's differentiation with its extended half-life?A: Carl Hansen (President and CEO): Both severity and frequency are important regulatory endpoints that need to be hit, and they correlate well. Dose escalation of fezolinetant showed improved efficacy in both frequency and severity, with the severity response lasting longer. I would be cautious about speculating too much, but we are anxiously awaiting the data to dig deeper into this. Q: Without disclosing targets, what technical features are required to create an acceptable therapeutic profile for TCEs in autoimmune diseases, particularly around depth and duration of cell depletion, cytokine release, and repeat dosing?A: Carl Hansen (President and CEO): You've highlighted the important things for cell depleters in autoimmunity: deep depletion, safety, and tolerability. However, it all depends on the target and the exact application, so without getting into details, I can't give a very detailed answer on that specific question. Q: What are your expectations for the placebo arm in the phase 2 trial, and what aspects of the trial design are meant to mitigate placebo response?A: Carl Hansen (President and CEO): All trials have shown a pronounced placebo response, and we expect ours to be in a comparable range. To reduce it, we've implemented good clinical operations, including a period where patients aren't told exactly what numbers are needed before enrollment. We feel confident about execution, but the exact placebo response is a big question we'll know shortly. Q: Will the phase 2 top-line data be out to 4 weeks in all patients, or will there be data out to 12 weeks in some patients? Also, how are you thinking about the phase 3 target patient populationexclusively non-hormonal alternatives or also refractory to HRT?A: Carl Hansen (President and CEO): The top-line data will be 4 weeks in all patients, and we won't report data on a subset out to 12 weeks. Historically, there's good follow-through between 4-week and 12-week data. The phase 2 was done with a single dose, so we're getting an effective dose-response curve. For phase 3, it's early to discuss design. At base case, there are over a million women in the US alone who are contraindicated for hormones. Additionally, there's a substantial number of patients with hot flashes from cancer therapy (prostate and breast cancer) where hormones aren't an option, plus those not tolerant to HRT. We'll consider all this once we have the data. Q: Can you provide additional color on the blinded safety data emerging from the trial, including overall adverse event rates and discontinuation rates?A: Carl Hansen (President and CEO): We haven't disclosed any safety data beyond what was shared on the last call. There's nothing that has given us pause or damaged our thesis. We'll wait for unblinding to have a close look, but things are on track. Q: What's your latest take on the debate about whether inhibiting NK3R in the median preoptic nucleus is crucial versus just suppressing the kisspeptin neurons in the infundibular nucleus?A: Carl Hansen (President and CEO): This is the key remaining scientific risk. Phase 1 data showed profound suppression of testosterone, deeper than small molecules, lasting the entire dosing interval. This reads through to the kisspeptin neurons, which are believed to be the most important. If those are the only neurons that matter, we'd expect For the complete transcript of the earnings call, please refer to the full earnings call transcript.

Study confirms western salt structure, identifies an eastern exploration target and establishes a staged technical pathway for further evaluation VANCOUVER, British Columbia, Aug. 06, 2026 (GLOBE NEWSWIRE) -- Vortex Energy Corp. (CSE: VRTX) (OTC: VTECF) (FSE: AA3) (“Vortex” or the “Company”) is pleased to announce, further to its news release dated July 16, 2026, that it has received the final technical study prepared by Lonquist Field Service (Canada), ULC (“Lonquist”) for the Company’s Robinsons River Salt Project (the “Project”), located approximately 35 kilometres south of Stephenville, Newfoundland and Labrador. The study integrates available geological, seismic, gravity and drilling information to refine the interpretation of the Project’s subsurface salt structures, assess available information regarding salt quality, identify potential future drilling targets and recommend a staged program of further technical work. The Company notes that the study was not prepared pursuant to NI 43-101, nor by a Qualified Person (as such term is defined in NI 43-101). Highlights Seismic, gravity and drilling data support the presence of a substantial western salt structure, with the 2024 drill hole VTX-24-W-02 intersecting an interval of approximately 278 m gross salt. Seismic interpretation identifies a potential incremental step-out west of VTX-24-W-02 where the salt section may reach approximately 350 metres in thickness. Reprocessed gravity data indicate a large, untested eastern target that may be deeper and potentially contain cleaner salt than the currently drilled western structure; this interpretation is based on gravity data and remains unconfirmed by drilling. Next steps include detailed core analysis, source-water and disposal studies and technical planning. The study confirms that Robinsons River hosts a thick halite-bearing system and identifies additional exploration potential, particularly within the untested eastern block. It also establishes a clearer framework for evaluating salt quality, subsurface geometry, drilling risk and potential commercial applications. Additional technical work will be required before the Company can determine whether the Project is suitable for commercial salt production, brine production or underground energy storage. No mineral resource or reserve, commercial production rate, storage-cavern design, storage capacity or economic evaluation has been established for the Project. Geological and Geophysical Interpretation Figure 1 presents the final gravity-inversion salt-thickness model, and Figure 2 presents the spatial differences between the seismic-derived and gravity-inversion interpretations. The latest Robinsons River interpretation incorporates legacy seismic surveys, airborne and surface gravity data, historical well information and the results of the Company’s recent drilling program. The study concluded that the western salt block is supported by the strongest combination of seismic, gravity and drilling control, with VTX-24-W-02 confirming the presence of a substantial halite-bearing interval within the interpreted structure. The study found that VTX-24-W-02 intersected an approximately 278-metre gross salt interval. The term “gross salt interval” includes the broader halite-bearing interval and should not be interpreted as 278 metres of continuous, high-purity halite. Legacy seismic data are considered sufficient to map the interpreted minimum extent of the western structure and indicate that the salt section may thicken locally toward a potential step-out target west of VTX-24-W-02. This proposed “Cloverleaf” location would represent an incremental step-out from the existing well and has an interpreted salt thickness of approximately 350 metres. As part of the study, previously acquired airborne gravity data were reprocessed after it was determined that the original processing had used an inappropriate terrain-correction. Revised terrain corrections were incorporated into an updated gravity inversion, providing an appropriate basis for comparing the gravity response with the seismic interpretation. Based on the seismic interpretation, the final gravity inversion used fixed assumptions for the geometry of the Ship Cove Limestone structure and an assumed salt density of 2.30 grams per cubic centimetre. Under those assumptions, the model indicates additional potential salt east of VTX-24-W-02 and comparatively less salt immediately west of the drill hole than represented by the seismic salt isochore model. The seismic and gravity datasets therefore provide related but not identical interpretations. Seismic data support the Cloverleaf step-out west of VTX-24-W-02, while the gravity-difference model indicates that the most substantial additional salt volume may occur farther east. These differences reflect the indirect nature of both datasets and will require additional density information and drilling control to resolve. The updated interpretation also identifies a western gravity anomaly beyond the currently defined salt structure and a larger eastern exploration target. The western anomaly is supported by gravity but occurs in an area where the available seismic data are considered marginal in quality. The eastern target occurs where a broad gravity low broadly coincides with seismic features interpreted as possible salt. The seismic support for this target is considered to be ambiguous. The prospective top of the eastern salt structure may occur approximately 1,100 to 1,300 metres below surface, and remains untested by drilling. The western block is considered to be shallower, closer to existing infrastructure and supported by a higher level of geological confidence. The eastern block is farther from infrastructure and deeper, but the gravity response may indicate a greater proportion of lower-density material and therefore potentially cleaner salt. This remains an exploration hypothesis and has not been confirmed through drilling, core analysis or open-hole density logging. Figure 1. Final gravity-inversion salt-thickness model for the Robinsons River Salt Project, showing the drill-tested western block and the untested western and eastern gravity anomalies. Contours represent modelled gross salt-interval thickness in metres. The inversion assumes a fixed geometry for the Ship Cove Limestone structure and a salt density of 2.30 grams per cubic centimetre. The mapped thicknesses are interpretive, have not been verified throughout by drilling and do not constitute a mineral resource or mineral reserve estimate. Figure 2. Difference between seismic-derived and gravity-inversion salt-thickness models, calculated as seismic-derived thickness minus gravity-inversion thickness. Negative values indicate areas where the gravity inversion models a thicker salt interval than the seismic interpretation, while positive values indicate the reverse. Values are expressed in metres and represent model-to-model differences, not measured salt thickness. Salt Quality The study reviewed the available descriptions of the VTX-24-W-02 core to provide a preliminary assessment of salt quality. The study describes the interval from 327.0 to 516.5 metres as a heterogeneous halite-bearing interval dominated by dark grey to black halite, with frequent mudstone interbeds, muddy salt, mud skins, fractures and minor cleaner translucent salt veins. Several comparatively thick intervals were described as higher-quality salt; however, mud-rich salt and salt-cemented mudstone intervals may materially reduce the overall salt percentage and influence the suitability of the deposit for potential commercial applications. Based solely on the available core descriptions, a preliminary, high-level assumption was made that salt may comprise approximately 65% to 75% by volume within the evaluated interval. This estimate is not based on systematic whole-interval chemical assays, does not represent a mineral-resource estimate and does not establish recoverable salt tonnage or suitability for cavern development. Detailed review of the existing core, measurement of representative rock densities and determination of the salt percentage by volume are recommended before the Company makes a decision regarding additional drilling. The approximately 278-metre gross salt interval extends from approximately 327 to 605 metres and is based on the broader lithological record. The detailed descriptions used for the preliminary salt-quality review cover the 189.5-metre interval from 327.0 to 516.5 metres. Detailed review of the complete core record is required to quantify halite, mudstone and other insoluble material throughout the full gross interval. The study also noted that available descriptions from VTX-23-W-01 identified intervals containing more than 20% insoluble material. The existing information therefore indicates that salt quality is unlikely to be homogeneous across the interpreted structures. Higher-purity and laterally continuous salt would generally reduce uncertainty associated with solution mining and potential cavern development, while mudstone interbeds, insoluble material and structural variability may affect dissolution behaviour, cavern geometry, operating performance and development risk. The study concludes that the western block appears to contain salt of moderate quality and that additional drilling may improve confidence in the geological model without necessarily identifying materially better salt. The eastern target may contain cleaner salt; however, this interpretation remains based on gravity data and is unverified. The study further noted that, relative to certain regional analogues, the currently available information indicates less favourable conditions for commercial viability and funding confidence at Robinsons River, and that encountering cleaner salt alone may not materially improve overall project confidence. Study Recommendations Figure 3 presents three conceptual target locations. The study identified the eastern target as the highest-priority conceptual exploration target because it offers the opportunity to confirm the depth, thickness and quality of the untested eastern structure. The western gravity anomaly represents a secondary target that is closer to infrastructure but has weaker seismic support and may contain salt of comparable or lower quality than the established western block. Additional drilling within the western block could improve confidence in the geological and gravity models but is considered unlikely to materially improve the currently interpreted salt quality. Before advancing further drilling, the report recommends a staged technical program using the existing core and datasets. Initial work would include detailed description and analysis of the VTX-24-W-02 core, representative density measurements, determination of salt percentage by volume, and evaluation of freshwater availability and disposal capacity. If the Company elects to proceed toward additional drilling or cavern evaluation, subsequent work could include detailed well design and risk planning, an updated geological and geophysical model, geomechanical and cavern-suitability studies, and a field and storage-capacity assessment. Figure 3. Conceptual exploration target locations identified in the study, including NL1-A, NL1-B and NL2-A, shown in relation to modelled gross salt-interval thickness, modelled depth-to-top-of-salt contours, existing drill holes, seismic coverage, mapped roads and Vortex claim boundaries. The locations are approximate planning concepts and do not represent approved drill sites. NL2-A is located within the untested eastern exploration target. The Company notes that it has not completed a preliminary economic assessment, pre-feasibility study, feasibility study or comparable economic evaluation for the Project. There is no assurance that the interpreted salt structures will support commercial salt extraction, brine production, hydrogen storage, compressed-air energy storage or any other underground-storage application. “Lonquist’s work has provided Vortex with a much clearer and more disciplined framework to advance the Robinsons River Project,” said Paul Sparkes, Chief Executive Officer of Vortex. “The study has reinforced confidence that a substantial salt-bearing system is likely located in the western block and identified meaningful exploration potential to the east. We now have an outline of practical steps that can be taken to reduce technical uncertainty before committing to another major drilling campaign. Our immediate focus will be on extracting the maximum value from the existing core and technical datasets.” Company’s Next Steps The Company will continue to review the Lonquist study and complete additional technical and commercial evaluation before determining whether to proceed with further work. This review will focus on the VTX-24-W-02 core, salt density and composition, water and disposal requirements, model refinement and land-package optimization. Any decision to advance drilling or development will remain subject to technical results, commercial considerations, financing, permitting and contractor availability. No storage cavern, brine-production facility or salt mine has been approved. Qualified Person The scientific and technical content of this news release has been reviewed and approved by Jared Suchan, Ph.D., P.Geo., Vice President of Exploration of the Company and a “Qualified Person” as defined by National Instrument 43-101. The Qualified Person’s review included the final technical study by Lonquist, and the geological, geophysical, drilling and interpretive information presented therein. The Qualified Person has not independently reprocessed all legacy seismic and gravity datasets underlying the study and has relied upon the work and interpretations of Lonquist and the specialist contractors identified in the study for those components. For additional information concerning the Project and the Company’s data-verification and quality-assurance procedures, readers are referred to the Company’s technical report entitled Independent Technical Report on the Robinsons River Salt Property, dated July 31, 2023, available under the Company’s profile on SEDAR+. Technical Disclosure and Limitations The work performed by Lonquist is a technical and planning study, and is not an independent technical report prepared in accordance with National Instrument 43-101 – Standards of Disclosure for Mineral Projects. It does not contain a mineral-resource or mineral-reserve estimate, preliminary economic assessment, pre-feasibility study or feasibility study. Gravity and seismic interpretations are indirect exploration methods and do not establish the composition, quality, continuity, recoverability or economic value of an interpreted salt structure. The gravity inversion is sensitive to assumed subsurface geometry and density values, and the eastern and western gravity anomalies remain untested exploration targets. References to potential salt production, brine production, hydrogen storage, compressed-air energy storage or other cavern applications are conceptual, and the suitability of the Project for any such application has not been demonstrated. About Vortex Energy Corp. Vortex Energy Corp. is an exploration stage company engaged principally in the acquisition, exploration, and development of mineral properties in North America. The Company is currently advancing its Robinson River Salt Project comprised of a total of 942 claims covering 23,500 hectares located approximately 35 kilometres south of the town of Stephenville in the Province of Newfoundland & Labrador. The Robinson River Salt Project is prospective for both salt and hydrogen salt cavern storage. The Company is also currently advancing its Fire Eye Uranium Property in the Athabasca Basin, a region renowned for its uranium deposits. On Behalf of the Board of Directors Paul SparkesChief Executive Officer, Director+1 (778) [email protected] Cautionary Note Regarding Forward-Looking Statements Certain statements contained in this press release constitute forward-looking information within the meaning of applicable Canadian securities laws. Forward-looking information relates to future events or future performance and is often, but not always, identified by words such as “could”, “intend”, “expect”, “believe”, “will”, “may”, “potential”, “planned”, “estimated”, “interpreted”, “conceptual”, “target”, “advance”, “continue”, “evaluate”, “assess”, “determine” and similar words or statements that certain actions, events or results “may”, “could”, “would”, “might” or “will” occur or be achieved. Forward-looking information in this press release includes, among other things, statements relating to: the Company’s interpretation of the Robinsons River Salt Project and the final Lonquist technical study; the presence, thickness, geometry, continuity, quality and potential extent of salt-bearing structures; the potential significance of the western block, the Cloverleaf step-out, the western gravity anomaly and the eastern exploration target; the possibility that the eastern target may be deeper or contain cleaner salt; the Company’s proposed or potential technical work, including core review, density measurements, salt-percentage determinations, source-water and disposal studies, model refinement, land-package optimization, drilling, well design, geomechanical work, cavern-suitability work and storage-capacity or field assessments; the potential for the Project to support commercial salt extraction, brine production, hydrogen storage, compressed-air energy storage or other underground-storage applications; the Company’s ability to reduce technical uncertainty, make decisions regarding additional drilling or development, obtain financing, permits, approvals, contractors, equipment and services, and advance the Project in the manner currently contemplated. Forward-looking information is subject to known and unknown risks, uncertainties and other factors that may cause actual results, performance or achievements to differ materially from those expressed or implied by such forward-looking information. Such risks and uncertainties include, among others: the risk that the Lonquist study, gravity inversion, seismic interpretation and other technical work may not accurately identify the location, thickness, geometry, continuity, composition, purity, recoverability or economic value of any salt structure; the risk that modelled or interpreted salt thicknesses, depth estimates, target locations, gravity anomalies or seismic features may not be confirmed by future drilling, logging, sampling, testing or analysis; the risk that the eastern or western targets do not contain salt of the depth, thickness, quality, continuity or configuration currently interpreted, or at all; risks associated with indirect exploration methods, terrain corrections, density assumptions, incomplete legacy datasets, limited drilling control, heterogeneous core, mudstone interbeds, insoluble material, fractures, structural complexity and variable dissolution behaviour; the risk that additional core analysis, density measurements, assays, source-water studies, disposal studies, geomechanical studies, cavern-suitability studies or other technical work may produce unfavourable, inconclusive or uneconomic results; the risk that the Project may not be suitable for commercial salt production, brine production, hydrogen storage, compressed-air energy storage or any other underground-storage application; risks that no mineral resource, mineral reserve, preliminary economic assessment, pre-feasibility study, feasibility study, storage-cavern design, storage capacity, commercial production rate or economic evaluation has been established for the Project; permitting, environmental, regulatory, community, access, surface-rights, infrastructure, water-supply, disposal, safety, contractor, equipment, financing and market risks; changes in costs, technical parameters, project priorities, exploration plans, applicable laws or regulatory expectations; delays, cost overruns or inability to complete the planned or contemplated work; and general risks inherent in mineral exploration and development, including the risk that exploration may be unsuccessful or fail to achieve the results anticipated by the Company. Although the Company believes that the assumptions and expectations reflected in the forward-looking information are reasonable as of the date hereof, undue reliance should not be placed on forward-looking information because the Company can give no assurance that such information will prove to be correct. Forward-looking information speaks only as of the date of this press release. The Company does not undertake any obligation to update or revise any forward-looking information, whether as a result of new information, future events or otherwise, except as required by applicable securities laws. The foregoing statements expressly qualify all forward-looking information contained in this press release. The Canadian Securities Exchange has not reviewed, approved, or disapproved the contents of this press release. Photos accompanying this announcement are available at: https://www.globenewswire.com/NewsRoom/AttachmentNg/021ea391-14b3-4f56-861e-65d2be2e2903 https://www.globenewswire.com/NewsRoom/AttachmentNg/59cd8357-eab8-4b65-81a4-c6eee9a84445 https://www.globenewswire.com/NewsRoom/AttachmentNg/36a5dbaf-1bdf-40c0-a488-4b2f8ab02511

-- Company to report ELEVATE-44-201 data from Cohort 1 open-label period by year-end 2026 -- -- ELEVATE-44-201 Cohort 2 enrollment complete with data expected in Q1 2027 -- -- Company to report ELEVATE-45-201 Cohort 1 data in October 2026 -- -- ELEVATE-45-201 Cohort 2 dosing ongoing at the increased dose of 10 mg/kg with data expected in H1 2027 -- -- Vertex to report VX-670 Phase 1/2 data in people living with DM1 in H2 2026 -- BOSTON, Aug. 05, 2026 (GLOBE NEWSWIRE) -- Entrada Therapeutics, Inc. (Nasdaq: TRDA) today reported financial results for the second quarter ended June 30, 2026, and highlighted recent business updates. “With multiple data readouts ahead in 2026, we are well positioned to deliver on important clinical milestones and further demonstrate the potential of our DMD franchise,” said Dipal Doshi, Chief Executive Officer of Entrada Therapeutics. “We are entering a catalyst-rich period with several near-term clinical data readouts including ELEVATE-45-201 Cohort 1 in October 2026, ELEVATE-44-201 Cohort 1 open-label period by year-end 2026 and ELEVATE-44-201 Cohort 2 data in the first quarter of 2027. These data are expected to further characterize the safety, tolerability and emerging functional profile of ENTR-601-44 and ENTR-601-45. Together, with the continued progress of VX-670 through our collaboration with Vertex on DM1, these milestones have the potential to further strengthen the clinical and strategic value of our pipeline as we work to bring transformative new treatment options to people living with serious neuromuscular diseases.” Recent Corporate Highlights Clinical-Stage Development Pipeline: Entrada continues to advance multiple clinical programs in people living with Duchenne muscular dystrophy (DMD) in the U.K., EU and U.S., complementing the ongoing clinical progress of its myotonic dystrophy type 1 (DM1) partnership (VX-670) with Vertex. ELEVATE-44-201: Enrollment complete for Cohort 2 of the global Phase 1/2 multiple ascending dose (MAD) portion of the clinical study of ENTR-601-44 in ambulatory participants living with DMD who are amenable to exon 44 skipping. Previously announced data from Cohort 1 achieved the primary objective of favorable safety and tolerability, with no discontinuations and no serious adverse events. Cohort 1 data also demonstrated early functional benefits in Time to Rise (TTR) and Time to Rise velocity versus placebo. A Long-Term Extension (LTE) platform study protocol (ENTR-DMD-202) was accepted by U.K. and European authorities. ENTR-DMD-202 will enable study participants continued access to ENTR-601-44 and provide for the collection of longer-term safety and efficacy data, including functional measures. The Company is on track to report data from the Cohort 1 (6 mg/kg) open-label period of the study by year-end 2026. The open-label period of the study will assess longer-term safety, continued changes in TTR and other functional measures that are normally assessed in DMD clinical studies. Additional data from Cohort 2 MAD (12 mg/kg) is expected in the first quarter of 2027 and data from Cohort 3 (up to 18 mg/kg) will follow, if needed. ELEVATE-44-102: Based on a review of safety, pharmacokinetic and pharmacodynamic data from Cohort 1 of the ELEVATE-44-201 study in the U.K. and EU, the Company plans to re-engage with the FDA to discuss increasing the planned starting dose in this clinical study. The Company will provide an update on clinical study design and timing following interactions with the FDA. ELEVATE-45-201: The Company has completed enrollment and dosing of Cohort 1 of the global Phase 1/2 MAD clinical study of ENTR-601-45 in ambulatory participants living with DMD who are amenable to exon 45 skipping. An independent Data Monitoring Committee (DMC) reviewed all available safety and PK data from the eight participants enrolled in Cohort 1 and recommended initiation of Cohort 2 at the increased dose of 10 mg/kg without any protocol modification. All participants from Cohort 1 have transitioned into the open-label, Phase 2 portion of the study. Cohort 2 dosing at 10 mg/kg is ongoing. The Company expects to report data from the Cohort 1 MAD (5 mg/kg) in October 2026, data from the Cohort 2 MAD (10 mg/kg) in the first half of 2027, and data from Cohort 3 (up to 15 mg/kg) will follow, if needed. ELEVATE-50-201: The Company received regulatory authorization from the U.K.’s Medicines and Healthcare Products Regulatory Agency (MHRA) and Research Ethics Committee to initiate a Phase 1/2 MAD clinical study of ENTR-601-50 in ambulatory participants living with DMD who are amenable to exon 50 skipping. The Company expects to submit additional global regulatory applications following a review of data from the ongoing studies of its lead programs. ENTR-601-51: The Company has completed Clinical Trial Authorization (CTA)-enabling studies for people living with DMD who are amenable to exon 51 skipping, which is the largest sub-population of exon-skipping amenable patients. The Company expects to submit global regulatory applications following a review of data from the ongoing studies of its lead programs. VX-670: Vertex has completed enrollment and continues dosing in the MAD portion of the GALILEO global Phase 1/2 clinical trial of VX-670 in people with DM1. The study is assessing safety and preliminary efficacy, including change from baseline in the splicing index and other endpoints evaluating muscle function and strength. Vertex is on track to complete dosing and report results in the second half of 2026. Expanding Preclinical Pipeline: The Company has generated compelling preclinical data from programs focused on ocular and metabolic diseases. The pipeline includes the advancement of two novel oligonucleotide-based programs for the potential treatment of inherited retinal diseases, where there exists high unmet need. The Company announced its first ocular candidate, ENTR-801, for the potential treatment of Usher syndrome type 2A (USH2A) and plans to announce a second clinical candidate in ocular disease in the second half of 2026. The Company will provide additional details on its clinical development strategy at that time. Upcoming Investor Conferences Cantor Global Healthcare Conference, New York, NY on September 9, 2026 Second Quarter 2026 Financial Results Cash Position: Cash, cash equivalents and marketable securities were $223.0 million as of June 30, 2026, compared to $295.7 million as of December 31, 2025. The decrease was primarily driven by cash used to fund operations. Based on current operating plans, the Company believes that its cash, cash equivalents and marketable securities as of June 30, 2026 will be sufficient to fund its operations into the third quarter of 2027. Collaboration Revenue: Collaboration revenue was $0.9 million for the second quarter of 2026, compared to $2.0 million for the same period in 2025. Research & Development (R&D) Expenses: R&D expenses were $35.4 million for the second quarter of 2026, compared to $37.9 million for the same period in 2025. The decrease was primarily driven by lower personnel and facility costs, partially offset by additional expenses incurred related to the Company’s DMD programs. General & Administrative (G&A) Expenses: G&A expenses were $10.5 million for the second quarter of 2026, compared to $10.9 million for the same period in 2025. The decrease was primarily driven by lower professional services costs. Net Loss: Net loss was $42.8 million for the second quarter of 2026, compared to $43.1 million for the same period in 2025. Patients and Their Care PartnersPatients and their care partners are a critical part of our community, and we are committed to keeping them informed and connected. To receive community updates in real time and read today’s quarterly update, please visit Community Updates on our corporate website. About Entrada TherapeuticsEntrada Therapeutics is a clinical-stage biopharmaceutical company aiming to transform the lives of patients by establishing a new class of genetic medicines that engage intracellular targets that have long been considered inaccessible. Through proprietary, versatile and modular approaches, Entrada is advancing a robust development portfolio of genetic medicines for the potential treatment of neuromuscular and inherited retinal diseases, among others. The Company’s lead oligonucleotide programs are in development for the potential treatment of people living with Duchenne muscular dystrophy who are exon 44, 45, 50 and 51 skipping amenable. Entrada has partnered to develop a clinical-stage program, VX-670, for myotonic dystrophy type 1. For more information about Entrada, please visit our website, www.entradatx.com, and follow us on LinkedIn. Forward-Looking StatementsThis press release contains express and implied forward-looking statements that involve substantial risks and uncertainties. All statements, other than statements of historical facts, contained in this press release, including statements regarding Entrada’s strategy, future operations, prospects and plans, objectives of management, the validation and differentiation of Entrada’s approach and EEV platform and its ability to provide a potential treatment for patients, the timing and achievement of anticipated clinical, regulatory and development milestones, expectations regarding Entrada’s Phase 1/2 MAD clinical study of ENTR-601-44, including the potential of the open-label period of the study to assess longer-term safety and additional functional measures, the potential of the LTE study and its ability to enable continued access to ENTR-601-44 for study participants and provide for the collection of longer-term safety and efficacy data, including functional measures, the timing of data from the Cohort 1 open-label period by year-end 2026 and Cohort 2 in the first quarter of 2027 with data from Cohort 3 to follow, if needed, expectations regarding the initiation of the planned ELEVATE-44-102 study in the U.S., including Entrada’s plans to re-engage with the FDA to discuss increasing the planned starting dose for the study and to provide an update on the clinical study design and timing following such planned interactions, the ability to recruit for and complete the global Phase 1/2 clinical studies of ENTR-601-44, ENTR-601-45, ENTR-601-50 and ENTR-601-51, the potential therapeutic benefits of Entrada’s EEV product candidates, including the potential for ENTR-601-44 to be a transformative treatment option, expectations regarding Entrada's Phase 1/2 MAD clinical study of ENTR-601-45, including the timing of data from Cohort 1 in October 2026 and Cohort 2 in the first half of 2027, with Cohort 3 to follow, if needed, expectations regarding regulatory filings and authorizations and the timing of initiation of the planned clinical studies of ENTR-601-50 and ENTR-601-51, including Entrada’s evaluation of the optimal timing for initiating such studies, the ability to advance therapeutic candidates in indications beyond neuromuscular disease, including but not limited to ocular disease, expectations regarding the timing of announcement of a second clinical candidate for ocular disease and Entrada’s clinical development strategy therefore in the second half of 2026, and the continued development and advancement of ENTR-601-44, ENTR-601-45, ENTR-601-50, and ENTR-601-51 for the treatment of DMD and ENTR-801 for the potential treatment of Usher syndrome type 2A and the partnered product candidate VX-670 for the potential treatment of DM1, expectations regarding the progress and success of Entrada’s collaboration with Vertex, including the timing of Vertex completing dosing and reporting results from the MAD portion of the global Phase 1/2 study of the VX-670 program in the second half of 2026, the ability to continue to expand and develop additional therapeutic programs and modalities, including further exon skipping programs, and the sufficiency of its cash resources for at least twelve months from the date of issuance of the condensed consolidated financial statements for the six months ended June 30, 2026, constitute forward-looking statements within the meaning of The Private Securities Litigation Reform Act of 1995. The words “anticipate,” “believe,” “continue,” “could,” “estimate,” “expect,” “intend,” “may,” “might,” “objective,” “ongoing,” “plan,” “predict,” “project,” “potential,” “should,” or “would,” or the negative of these terms, or other comparable terminology are intended to identify forward-looking statements, although not all forward-looking statements contain these identifying words. Entrada may not actually achieve the plans, intentions or expectations disclosed in these forward-looking statements, and you should not place undue reliance on these forward-looking statements. Actual results or events could differ materially from the plans, intentions and expectations disclosed in these forward-looking statements as a result of various important factors, including: uncertainties inherent in the identification and development of product candidates, including the conduct of research activities and the initiation and completion of preclinical studies and clinical studies; uncertainties as to the availability and timing of results from preclinical and clinical studies; the timing of and Entrada’s ability to submit and obtain regulatory clearance and initiate clinical studies; whether results from preclinical studies or clinical studies will be predictive of the results of later preclinical studies and clinical studies; whether Entrada’s cash resources will be sufficient to fund the Company’s foreseeable and unforeseeable operating expenses and capital expenditure requirements; as well as the risks and uncertainties identified in Entrada’s filings with the Securities and Exchange Commission (SEC), including the Company’s most recent Form 10-K and in subsequent filings Entrada may make with the SEC. In addition, the forward-looking statements included in this press release represent Entrada’s views as of the date of this press release. Entrada anticipates that subsequent events and developments will cause its views to change. However, while Entrada may elect to update these forward-looking statements at some point in the future, it specifically disclaims any obligation to do so. These forward-looking statements should not be relied upon as representing Entrada’s views as of any date subsequent to the date of this press release. Investor ContactDoug SnowHead of Investor [email protected] Patient Advocacy ContactSarah FriedhoffHead of Patient [email protected] Media ContactMegan Prock McGrathCTD Comms, [email protected]

Interested in AbCellera Biologics Inc.? Here are five stocks we like better. ABCL635 data is expected very soon: AbCellera completed enrollment and initial dosing ahead of schedule in its Phase I study for menopause-related hot flashes. The four-week top-line results will assess safety and efficacy, with the company seeking at least a 20% placebo-adjusted reduction in symptoms and no meaningful liver-enzyme increase. Partnership momentum is growing: Recent T-cell engager collaborations with Vertex and Jazz provide $112 million in near-term upfront payments and potential downstream milestones exceeding $2 billion, with Jazz’s broader opportunity potentially surpassing $4 billion. Pipeline investment is weighing on financial results: Q2 revenue fell to about $4 million while the net loss widened to roughly $55 million as R&D spending increased. AbCellera ended the quarter with $567 million in cash and marketable securities plus committed government funding, which it expects can support at least three years of pipeline investment. Argenx's 28% Surge & Promising Product Propel Investor Confidence AbCellera Biologics (NASDAQ:ABCL) said it expects to report top-line data “very soon” from its Phase I study of ABCL635, an antibody being evaluated for moderate-to-severe vasomotor symptoms, or hot flashes, associated with menopause. President and Chief Executive Officer Dr. Carl Hansen said enrollment and initial dosing in the study of post-menopausal women were completed in June, ahead of schedule. The company previously reported interim Phase I data in healthy male volunteers that showed target engagement, which supported advancing the program into the patient study. → SpaceX’s First Earnings Report Could Decide Whether Shorts or Bulls Have Control Hansen said positive results could substantially de-risk ABCL635 and support late-stage development in menopause-related vasomotor symptoms, as well as clinical studies in vasomotor symptoms associated with cancer treatments. During the question-and-answer session, Hansen said AbCellera is seeking a clean safety profile and efficacy comparable with that of approved small-molecule treatments. On hot-flash frequency, the company is looking for a placebo-adjusted response “on the order of 20% at least,” along with a reduction of at least two hot flashes per day. → 3 Drone Stocks That Should Soar After the Summer Slump The forthcoming top-line release will include four-week data for all patients, Hansen said. It will not include 12-week data for a subset of patients. The Phase I study used a single dose of ABCL635, and the company expects the treatment effect to diminish by 12 weeks as drug levels decline. AbCellera has emphasized potential safety and convenience differentiation for ABCL635. Hansen said the company has not observed a perceptible increase in liver enzymes in the data reviewed to date. He noted that approved small-molecule treatments have liver-monitoring requirements, while AbCellera believes an antibody should avoid liver effects associated with small-molecule metabolism. → The Bitcoin Comeback May Already Be Underway—2 ETFs for Exposure Hansen also said ABCL635 is designed to be specific to the NK3R target and is not expected to produce somnolence associated with binding to NK1R. The company is considering once-monthly dosing as a potential convenience advantage. Still, Hansen characterized the role of blocking NK3R in the medial preoptic nucleus as a remaining scientific question for the program. He said the company’s earlier Phase I data demonstrated profound and sustained testosterone suppression, indicating target engagement in KNDy neurons believed to be key drivers of vasomotor symptoms. The upcoming patient data will help answer whether activity in other areas of the brain is also needed for clinical efficacy. AbCellera said it sees an opportunity among women who cannot use hormone therapy, as well as patients experiencing hot flashes related to breast-cancer and prostate-cancer treatment. Hansen estimated that more than 1 million women in the U.S. could benefit from a non-hormonal option, though he said it was too early to discuss the precise design of a potential Phase III program. Elsewhere in the internal pipeline, Hansen said ABCL688 and ABCL386 continue through investigational-new-drug-enabling activities and are expected to enter Phase I/II studies in 2027. The company plans to disclose additional information when those programs reach the clinic. AbCellera’s Phase I study of ABCL575 has completed dosing and remains on track for a fourth-quarter readout. The company said it intends to complete Phase I studies for ABCL575 but currently does not plan to advance the program beyond that stage. Hansen also said the company did not meet its prior goal of moving another program into IND-enabling activities during the first half of 2026, though he said discovery work was making progress. The company highlighted new business-development activity around its T-cell engager, or TCE, platform. Hansen said AbCellera has spent five years building capabilities in TCE discovery, including antibody panels, costimulatory antibodies, protein-engineering workflows, in vitro assays and translational models. AbCellera recently entered TCE collaborations with Vertex Pharmaceuticals and Jazz Pharmaceuticals, following an earlier TCE collaboration with AbbVie. Vertex: The collaboration focuses on TCEs for autoimmune diseases and other conditions. AbCellera will receive $28 million in upfront payments and is eligible for additional milestone payments and tiered royalties on net sales. The agreement also includes a potential option for AbCellera to conduct process development and clinical manufacturing. Jazz: The agreement includes three confirmed discovery programs and $84 million in near-term upfront payments. AbCellera has received $56 million for the first two programs and expects another $28 million when the third program begins within 12 months. The company is eligible for more than $2 billion in potential downstream payments and mid-single-digit to low-double-digit tiered royalties. With two possible additional programs, the potential value could exceed $4 billion. Hansen said AbCellera does not expect a major change in its resource allocation to TCEs, but its work is shifting from building foundational capabilities to executing internal and partner programs. He said the company continues to devote significantly more effort to its GPCR and ion-channel activities than to TCEs. Chief Financial Officer Andrew Booth reported approximately $4 million in second-quarter revenue, compared with roughly $17 million in the same quarter of 2025. Revenue during the latest quarter consisted primarily of research fees. Research and development expenses totaled about $46 million, up approximately $7 million from a year earlier, reflecting investment in internal programs. Sales, general and administrative expenses declined to about $14 million from $22 million, which Booth attributed to the conclusion of intellectual-property litigation and changes to teams following the company’s focus on its internal pipeline. AbCellera reported a net loss of roughly $55 million, or $0.18 per share, compared with a loss of about $35 million a year earlier. The company ended the quarter with $567 million in total cash and marketable securities, including approximately CAD$420 million invested in short-term marketable securities. Booth said AbCellera also has roughly $110 million in committed government funding available, resulting in more than CAD$675 million of available liquidity when unused secured government funding is included. The company believes it has sufficient liquidity to fund at least the next three years of pipeline investments. AbCellera also appointed Dr. Victor Sandor and Dr. Lynn Seely as independent directors. Hansen said the two executives bring development experience spanning oncology, women’s health, immunology and endocrinology. AbCellera Biologics Inc (NASDAQ: ABCL) is a biotechnology company specializing in the discovery and development of therapeutic antibodies. The company's technology platform integrates single-cell screening, microfluidics, high-throughput sequencing and artificial intelligence to rapidly identify and optimize antibody candidates against a wide range of disease targets. By combining experimental data with machine learning, AbCellera accelerates early-stage drug discovery and improves the efficiency of lead candidate selection. AbCellera primarily operates through partnerships with pharmaceutical and biotechnology firms, offering its antibody discovery services on a fee-for-service and milestone-driven basis. This instant news alert was generated by narrative science technology and financial data from MarketBeat in order to provide readers with the fastest reporting and unbiased coverage. Please send any questions or comments about this story to [email protected]. The article "AbCellera Biologics Q2 Earnings Call Highlights" was originally published by MarketBeat. View MarketBeat's top stocks for August 2026.

CRISPR Therapeutics CRSP incurred second-quarter 2026 loss of 94 cents per share, which was narrower than the Zacks Consensus Estimate of a loss of $1.10. The company had incurred a loss of $2.40 in the year-ago quarter. Total revenues were $10.2 million in the second quarter (comprising $10 million in collaboration revenue and the rest from grant revenues), which also beat the Zacks Consensus Estimate of $7 million. In the year-ago period, CRSP had recorded total revenues of $0.89 million, which comprised only grant revenues. Year to date, shares of CRISPR Therapeutics have lost 5.4% while the industry has risen 2.8%. Image Source: Zacks Investment Research CRISPR Therapeutics and partner Vertex Pharmaceuticals’ VRTX CRISPR/Cas9 gene therapy, Casgevy, is approved across the United States and Europe for two blood disorder indications — sickle cell disease (SCD) and transfusion-dependent beta thalassemia (TDT). Per the deal terms, Vertex leads global development, manufacturing and commercialization of Casgevy and splits program costs and profits worldwide with CRISPR Therapeutics in a 60:40 ratio. The FDA recently approved Casgevy for use in children aged two years and older with SCD or TDT. Regulatory filings were also completed in Saudi Arabia and the United Kingdom for children aged five to 11 years. In May, Vertex secured reimbursement in Germany for eligible patients aged 12 years and older. Vertex recorded Casgevy sales of $76 million in the second quarter of 2026. Sales increased 78% sequentially and 151% year over year, reflecting continued commercial uptake. Research and development expenses were $67.2 million in the second quarter, down 3.9% year over year. The decline primarily reflected lower employee and facility-related expenses, partly offset by higher license fees. General and administrative expenses declined 6.9% to $17.6 million, mainly due to lower employee-related costs, including stock-based compensation. Collaboration expense, net, fell 10.8% to $40.3 million, driven by an increase in CRSP’s share of Casgevy revenues under the Vertex collaboration economics. Acquired in-process research and development expenses were $2.5 million compared with $96.3 million in the year-ago quarter. The prior-year amount reflected costs related to the company’s agreement with Sirius Therapeutics. CRSP exited June with $2.36 billion in cash, cash equivalents and marketable securities, down from $2.44 billion at the end of March 2026. The sizeable cash position provides CRISPR Therapeutics with resources to support commercialization activities and advance its diversified clinical pipeline. Multiple clinical updates are expected during the second half of 2026. CRISPR Therapeutics continues to prioritize CTX310, an investigational gene-editing therapy targeting ANGPTL3. The candidate is advancing in a phase Ib study for severe hypertriglyceridemia and refractory hypercholesterolemia, with U.S. studies initiated and ex-U.S. studies ongoing. An update on this study is expected in the second half of 2026. CRSP initiated a phase I study of CTX340 in patients with refractory hypertension after receiving FDA clearance. It also started a phase I study of CTX460 for treating alpha-1 antitrypsin deficiency. The preclinical CTX321 program, which targets elevated lipoprotein(a), is progressing through investigational new drug and clinical trial application-enabling studies. An update is expected later in 2026. Zugo-cel, CRSP’s allogeneic CAR-T candidate, is being evaluated across autoimmune diseases and blood cancers. Two ongoing phase I autoimmune basket studies cover rheumatology indications and hematologic disorders, including systemic lupus erythematosus, systemic sclerosis, inflammatory myositis, immune thrombocytopenic purpura and warm autoimmune hemolytic anemia. A third phase I study has begun targeting various autoimmune neurologic diseases. Enrollment continues across the broader autoimmune program, with additional updates expected in the second half of 2026. In immuno-oncology, the phase I/II study of zugo-cel in B-cell malignancies remains underway. CRSP is also evaluating zugo-cel with Eli Lilly’s Jaypirca (pirtobrutinib) in aggressive B-cell lymphomas. Several updates are expected in the second half of 2026. The company’s siRNA candidate, CTX611, is advancing in a phase II study for patients undergoing total knee arthroplasty (TKA). CRSP expects to provide an update in the second half of 2026. CRISPR Therapeutics AG price-consensus-eps-surprise-chart | CRISPR Therapeutics AG Quote CRISPR Therapeutics currently carries a Zacks Rank #3 (Hold). Some better-ranked stocks in the biotech sector are Repligen RGEN and Liquidia Corporation LQDA, each currently sporting a Zacks Rank #1 (Strong Buy). You can see the complete list of today’s Zacks #1 Rank stocks here. Over the past 60 days, estimates for Repligen’s 2026 earnings per share have risen from $1.99 to $2.06, while estimates for 2027 have increased from $2.57 to $2.62 during the same time. RGEN shares have declined 10.2% year to date. Repligen’s earnings beat estimates in each of the trailing four quarters, with the average surprise being 16.80%. Over the past 60 days, estimates for Liquidia’s 2026 earnings per share have risen from $2.97 to $3.02, while estimates for 2027 have increased from $4.81 to $5.31 during the same time. LQDA shares have surged 143.1% year to date. Liquidia’s earnings beat estimates in three of the trailing four quarters, while missing the same on the remaining occasion, with the average surprise being 54.40%. Want the latest recommendations from Zacks Investment Research? Today, you can download 7 Best Stocks for the Next 30 Days. Click to get this free report CRISPR Therapeutics AG (CRSP) : Free Stock Analysis Report Vertex Pharmaceuticals Incorporated (VRTX) : Free Stock Analysis Report Repligen Corporation (RGEN) : Free Stock Analysis Report Liquidia Corporation (LQDA) : Free Stock Analysis Report This article originally published on Zacks Investment Research (zacks.com). Zacks Investment Research

Vertex Pharmaceuticals Incorporated VRTX raised its 2026 revenue outlook as cystic fibrosis growth and contributions from newer products accelerated. Management framed 2026 as an execution year, with commercial scaling, a near-term renal launch and the pending Crinetics acquisition shaping diversification. Chief operating officer and CFO Charles Wagner said that second-quarter 2026 revenues rose 12% to $3.33 billion, topping the Zacks Consensus Estimate of $3.23 billion. Non-GAAP earnings of $4.73 per share missed the consensus estimate of $4.79 by 6 cents. Wagner raised its full-year revenue guidance to $13.1-$13.2 billion from $12.95-$13.1 billion. The outlook still assumes at least $500 million from CASGEVY and JOURNAVX, and a 150-basis-point foreign-exchange benefit. He kept non-GAAP operating expense guidance at $5.65-$5.75 billion but expects spending near the high end. The gross margin is expected just below 86%, reflecting product mix and manufacturing investments. Vertex Pharmaceuticals Incorporated price-consensus-eps-surprise-chart | Vertex Pharmaceuticals Incorporated Quote CEO and president Reshma Kewalramani emphasized ALYFTREK as the new standard of care in cystic fibrosis. Management said that global CF revenues grew 11%, supported by ALYFTREK uptake, TRIKAFTA demand and higher U.S. net pricing. Chief commercial officer Duncan McKechnie said that ALYFTREK exceeded $1 billion in first-half revenues. Most sales came from patients switching from TRIKAFTA, with new, returning and rare-mutation patients also contributing. Kewalramani set a demanding bar for next-generation CF programs. Vertex will advance assets only if they can move more patients below the 30-millimoles-per-liter sweat chloride threshold while retaining once-daily dosing and favorable drug properties. Chief commercial officer Duncan McKechnie said that CASGEVY revenues were $76 million, surging about 75% sequentially and more than 150% year over year. More infusions occurred in the first half than in all of 2025. JOURNAVX generated $50 million, with prescriptions rising about 45% sequentially to roughly 535,000. McKechnie said that prescription growth is ahead of the 2026 forecast, though inventory and patient-support usage continue to affect recognized revenues. McKechnie expects gross-to-net levels to normalize in the first half of 2027. He tied the timing to payer restrictions and heavier patient-support use as physician adoption outpaces access education. Kewalramani highlighted the Nov. 30 PDUFA date for povetacicept in IgA nephropathy and said that launch preparation is in its final stages. Vertex has completed hiring a renal field force, with about 90% bringing nephrology experience. McKechnie said that the commercial case rests on efficacy, tolerability and once-monthly at-home administration. Vertex expects its field organization, payer work and patient-support programs to support adoption upon approval. The renal pipeline extends beyond IgAN. Kewalramani said that inaxaplin’s AMPLITUDE interim analysis remains on track for early 2027, while AMPLIFIED results and VX-670 data in myotonic dystrophy type 1 are due in the second half of 2026. A JPMorgan analyst asked whether new IgAN drugs could separate on kidney-function outcomes. Kewalramani said that deeper reductions in proteinuria, hematuria and disease-driving antibodies should matter through their effect on progression to dialysis, transplant or death. A Citi analyst pressed on Vertex’s next CF generation. Kewalramani reiterated that sweat chloride distribution, safety, once-daily dosing and drug-drug interaction profiles will determine whether a candidate advances. A Wells Fargo analyst asked about JOURNAVX treatment duration. McKechnie said that prescriptions average five days in hospitals and 12-14 days in retail, producing an overall average of 10-11 days that has remained stable. Management’s tone remained confident but spending-aware. The company is prioritizing launch execution in pain and renal while maintaining CF growth and advancing clinical readouts. The pending Crinetics acquisition would add rare endocrine diseases as a fifth pillar. Guidance excludes the transaction, which Vertex expects to close in the third quarter before updating its 2026 outlook. VRTX currently carries a Zacks Rank #3 (Hold), a neutral near-term signal. Its Value Score and Growth Score are C, while Momentum Score and VGM Score are D, indicating middle-range value and growth characteristics but weaker momentum and combined style positioning. You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here. Zacks Style Scores complement the Rank, with A or B scores preferred over lower grades. The current mix lacks strong style confirmation, and the Zacks Rank can change as analysts revise estimates after the reported results. Want the latest recommendations from Zacks Investment Research? Today, you can download 7 Best Stocks for the Next 30 Days. Click to get this free report Vertex Pharmaceuticals Incorporated (VRTX) : Free Stock Analysis Report This article originally published on Zacks Investment Research (zacks.com). Zacks Investment Research

Our analysts just identified a stock with the potential to be the next Nvidia. Tell us how you invest and we'll show you why it's our #1 pick. Tap here. Second quarter revenue growth of 12% was driven by the continued dominance of the cystic fibrosis (CF) portfolio and accelerating contributions from newer launches CASGEVY and JOURNAVX. Management emphasized that the bar for new CF therapies is exceptionally high, as ALYFTREK already brings approximately 75% of patients ages 12 and older into the carrier range of sweat chloride levels. The announced acquisition of Crinetics Pharmaceuticals establishes a fifth strategic pillar in rare endocrine diseases, adding two lead assets with an estimated $5 billion peak sales potential. The renal franchise is positioned as a primary growth driver, with povetacicept (Pove) in IgAN receiving a November 30 PDUFA date and showing potentially best-in-class efficacy in proteinuria reduction. Type 1 diabetes strategy is shifting to prioritize the VX-017 'Type O' universal donor program, which doubles the addressable market opportunity to approximately 120,000 patients compared to the original program. Operational focus remains on a 'high-science' specialty commercial model, leveraging existing CF infrastructure to launch upcoming renal and endocrine therapies efficiently. Full-year 2026 revenue guidance was raised to $13.1 billion to $13.2 billion, assuming continued CF strength and at least $500 million from non-CF products. Management expects gross margins to normalize at just under 86% as the product mix shifts toward CASGEVY, which carries higher manufacturing costs than small-molecule products. Key clinical catalysts for the second half of 2026 include proof-of-concept data for VX-828 in CF, DM1 study results, and expanded population data for inaxaplin in AMKD. The Crinetics acquisition is expected to close in Q3 2026, with management projecting the transaction to become accretive to non-GAAP operating income by 2029. Updated regulatory and commercial timelines for the Type 1 diabetes portfolio are expected later this year as the company evaluates streamlining the Type O program. JOURNAVX gross-to-net margins are currently impacted by high Patient Support Program (PSP) usage as physician education on payer restrictions catches up to rapid prescription growth. Management flagged that foreign exchange rates provided a 170 basis point benefit in Q2 but expects this tailwind to diminish in the second half of the year. Commercial spending is growing faster than R&D as the company builds entirely new business units for pain and renal, whereas R&D costs are being managed through internal resource redeployment. The voluntary manufacturing pause for zimislecel has been resolved, but it resulted in a strategic pivot to accelerate the universal donor VX-017 program. One stock. Nvidia-level potential. 30M+ investors trust Moby to find it first. Get the pick. Tap here. Prescription growth is currently outpacing unrestricted payer access, leading to higher-than-forecasted use of the Patient Support Program to ensure patient access. Management expects gross-to-net to normalize in line with other branded oral medicines by the first half of 2027 as physicians learn to navigate minor quantity limits and prior authorizations. Management believes Pove's 52% proteinuria reduction and significant impact on Gd-IgA1 antibodies will lead to superior long-term outcomes regarding time to end-stage renal disease. The product is positioned for market leadership based on a 'trifecta' of efficacy, safety, and patient-centric once-monthly at-home dosing via auto-injector. The time differential between the original zimislecel program and the universal Type O program (VX-017) has shortened due to the recent manufacturing pause. Vertex is exploring a streamlined regulatory strategy that could potentially bring the Type O program to market first or very shortly after the original program. Vertex will only advance assets into Phase II that show clear potential to beat ALYFTREK's efficacy in bringing more patients to sweat chloride levels below 30 millimoles. Management dismissed competitors' incremental sweat chloride data, stating that the true measure of success is the proportion of patients reaching the carrier-level threshold across all genotypes.