REGN

Sound Shore Management, an investment management firm, has released its investor letter for the second quarter of 2026. The letter can be downloaded here. The Sound Shore Fund’s Investor Class (SSHFX) and Institutional Class (SSHVX) rose 10.48% and 10.58% in the second quarter of 2026, trailing the Russell 1000 Value Index’s 13.87% and the S&P 500’s 15.20% returns. Over three years, SSHFX and SSHVX posted annualized gains of 19.41% and 19.66%, outperforming the Russell Value (17.79%) but underperforming the S&P 500 (20.61%). The powerful rebound of stocks in the quarter was driven by strong performances in AI and semiconductor sectors, amidst easing inflation fears and a stable labor market. The portfolio also benefited from the AI wave in the second quarter. The ongoing AI revolution is creating significant investment opportunities in multiple sectors, and Sound Shore remains committed to long-term assessments of a company’s earning power, targeting stocks with durable management strategies. Also, check the fund’s top five holdings to see its best picks in 2026. In its Q2 2026 investor letter, Sound Shore Management highlighted Regeneron Pharmaceuticals, Inc. (NASDAQ:REGN). Regeneron Pharmaceuticals, Inc. (NASDAQ:REGN) is a biotechnology company that develops and commercializes medicines to treat various diseases. On August 26, 2026, Regeneron Pharmaceuticals, Inc. (NASDAQ:REGN) closed at $814.79 per share, reflecting a market capitalization of $83.89 billion. Regeneron Pharmaceuticals, Inc. (NASDAQ:REGN) posted a one‑month return of 10.35%, while its shares gained 40.58% over the past 52 weeks. Sound Shore Management stated the following regarding Regeneron Pharmaceuticals, Inc. (NASDAQ:REGN) in its Q2 2026 investor letter: Regeneron Pharmaceuticals, Inc. (NASDAQ:REGN) is not on our list of the 40 Most Popular Stocks Among Hedge Funds. As per our database, 63 hedge fund portfolios held Regeneron Pharmaceuticals, Inc. (NASDAQ:REGN) at the end of the first quarter, which was 72 in the previous quarter. While we acknowledge the potential of Regeneron Pharmaceuticals, Inc. (NASDAQ:REGN) as an investment, we believe certain AI stocks offer greater upside potential and carry less downside risk. If you're looking for an extremely undervalued AI stock that also stands to benefit significantly from Trump-era tariffs and the onshoring trend, see our free report on the best short-term AI stock. In another article, we covered Regeneron Pharmaceuticals, Inc. (NASDAQ:REGN) and shared the list of stocks surpassing earnings expectations. In addition, please check out our hedge fund investor letters Q2 2026 page for more investor letters from hedge funds and other leading investors. READ NEXT: 33 Stocks That Should Double in 3 Years and 15 Stocks That Will Make You Rich in 10 Years. Disclosure: None. This article is originally published at Insider Monkey.

The FDA approved Pasatru, whose generic name is garetosmab, of Regeneron Pharmaceuticals, Inc. (NASDAQ:REGN) for adults with fibrodysplasia ossificans progressiva. FOP is an ultra-rare genetic disorder in which bone forms inside muscles, tendons, and ligaments, progressively restricting movement. In a 56-week Phase 3 trial involving 63 adults, the approved 3-milligram-per-kilogram dose reduced the number of new abnormal bone lesions by 94% compared with placebo. The decision completed an unusual clinical recovery. Regeneron paused an earlier study in 2020 after five patients died during its open-label portion, when all participants were receiving active treatment. The published analysis later considered a relationship to treatment unlikely, although causality could not be ruled out. For Regeneron Pharmaceuticals, Inc. (NASDAQ:REGN), Pasatru is a regulatory and scientific victory whose earnings potential is constrained by an exceptionally small market. The company’s existing scale makes that limitation difficult to ignore. Regeneron Pharmaceuticals, Inc. (NASDAQ:REGN) generated second-quarter revenue of $4.29 billion, up 17%, while company-defined non-GAAP diluted EPS reached $14.29. Global Dupixent sales, recorded by partner Sanofi, increased 38% to approximately $6 billion, and U.S. Eylea HD sales rose 52% to $596 million. Against those franchises, even a successful Pasatru launch would have limited influence on consolidated results. The approval demonstrates that Regeneron Pharmaceuticals, Inc. (NASDAQ:REGN) can recover a program after a major clinical setback. Following the 2020 dosing pause, the company worked with regulators to design a late-stage study that produced a statistically significant reduction in new bone lesions. Pasatru also validates research into Activin A, which activates the mutant ACVR1/ALK2 receptor and triggers abnormal bone formation in FOP. That platform value may matter more than initial sales. Regeneron Pharmaceuticals, Inc. (NASDAQ:REGN) plans to begin a pediatric trial later in 2026, which could eventually expand the eligible population. The regulatory recovery may also strengthen confidence in the company’s ability to advance other rare-disease programs from internally discovered biology. Regeneron Pharmaceuticals, Inc. (NASDAQ:REGN) is entering an exceptionally small pharmaceutical market. Published prevalence estimates generally range from approximately one case per one million to one per two million people. Only approximately 800 to 900 known or confirmed cases have been identified globally, although additional patients may remain undiagnosed. Pasatru is currently approved only for adults, further narrowing its immediate market. Competition is already established. Ipsen’s oral therapy Sohonos received FDA approval in 2023 for adults and certain pediatric patients. Pasatru’s earlier safety history will also remain important during commercialization. Incyte and Mirum are jointly advancing zilurgisertib, while Ashibio is separately developing andecaliximab. Insider Monkey’s hedge fund database shows that 72 hedge funds held positions in Regeneron Pharmaceuticals, Inc. (NASDAQ:REGN) at the end of the first quarter of 2026, compared with 75 funds at the end of the preceding quarter. These figures reflect holdings as of March 31, 2026, and do not capture later trades or investors’ reactions to the Pasatru approval for Regeneron Pharmaceuticals, Inc. (NASDAQ:REGN). Pasatru is unlikely to move near-term earnings materially for Regeneron Pharmaceuticals, Inc. (NASDAQ:REGN), given the small diagnosed population and existing competition. Its greater value lies in rescuing a troubled program, validating the Activin A science and demonstrating that a major setback can still lead to an approved medicine. While we acknowledge the potential of REGN as an investment, we believe certain AI stocks offer greater upside potential and carry less downside risk. If you're looking for an extremely undervalued AI stock that also stands to benefit significantly from Trump-era tariffs and the onshoring trend, see our free report on the best short-term AI stock. READ NEXT: ConocoPhillips (COP): Wall Street Sees More Upside Despite Leadership Shakeup and Here is Why Chevron (CVX) is a Favorite Among Hedge Funds Disclosure: None. This article is originally published at Insider Monkey.

Interested in Veeva Systems Inc.? Here are five stocks we like better. Veeva exceeded guidance in fiscal 2027 Q2, reporting $928 million in revenue and $416 million in non-GAAP operating income. Management raised its full-year outlook, with commercial subscription revenue up approximately 13% year over year. Commercial-cloud growth was broad-based across CRM, content, data products, Crossix and Ostro. Veeva cited strong CRM momentum, including Vault CRM selections from Eli Lilly, Biogen and Regeneron, and sees potential to win back customers that encountered challenges with Salesforce implementations. Falcon AI is emerging as a major growth focus, with strong customer interest in AI agents designed to improve efficiency, compliance and costs. Veeva is also investing in newer clinical products such as EDC, eCOA, RTSM, Safety and LIMS, while developing its horizontal CRM initiative, Aspen. Buy the Dip or Run: 3 Software Stocks Down 50% Face Their Moment of Truth Veeva Systems (NYSE:VEEV) reported fiscal 2027 second-quarter revenue of $928 million and non-GAAP operating income of $416 million, with Chief Executive Officer Peter Gassner saying results exceeded the company’s guidance. Management highlighted record CRM performance, broad commercial-cloud momentum and growing customer interest in its AI offerings. The quarter ended July 31, 2026, and the company said it raised its guidance for the fiscal year. Chief Financial Officer Brian Van Wagener said commercial subscription revenue increased about 13% year over year, with double-digit growth even excluding Crossix. → What Rising Delivery Forecasts Say About Rivian's Stock Prospects Down 20%+, These 3 Software Stocks Are Boosting Buybacks Van Wagener said commercial-cloud growth was not driven by a single offering. Instead, performance was broad-based across CRM, content, data products, Crossix and Ostro. Crossix continued to have “a lot of headroom for growth,” he said, while CRM revenue continued to grow despite prior investor concerns that the category could decline. Veeva’s commercial performance also reflected new customers and brands in Data Cloud, growth in Crossix measurement and audiences, and demand for CRM add-ons and content products, according to Van Wagener. → NVIDIA Reveals $21 Billion SpaceX Stake: Signal of Confidence or Circular Financing? Veeva Systems: Increasing NDR and Other Wins Paul Shawah, Veeva’s executive vice president of strategy, said the company had an “exceptional” CRM quarter, citing Vault CRM selections by Eli Lilly, Biogen and Regeneron. He attributed the wins to customer trust in Veeva’s ability to deliver and to product performance. Shawah said Veeva has commitments from 12 of the top 20 biopharma companies, with two remaining decisions expected by the end of the year. Management also discussed customers that previously chose Salesforce over Veeva CRM. Gassner said a handful of large customers selected Salesforce, in some cases about two years ago, but those implementations have encountered delays and challenges because of the complexity of the product. He said Veeva believes it could win back some of those customers, potentially in full or in selected regions, with most potential win-backs occurring in 2027 and 2028. → Berkshire Boosts Its Bet: This AI Hyperscaler Is Now a Top-3 Holding “We want to be your plan B,” Gassner said of Veeva’s discussions with those customers. Veeva CRM remains available as a backstop through the end of 2029, he noted. Gassner described Veeva Falcon as a new category for the company: “agentic labor.” Unlike Veeva’s traditional cloud software, data and consulting businesses, Falcon is intended to perform work through AI agents. He said customer interest is high, particularly because organizations see potential for cost savings, compliance improvements and greater efficiency. However, Gassner said Veeva is currently the limiting factor because it needs to further prepare the product and work with early adopters. He emphasized that Falcon deployments should not require the extensive data mapping, system cutovers or extract-transform-load work often associated with enterprise software implementations. Veeva expects Falcon sales to be directed primarily toward business-unit leaders and operations executives rather than IT departments. Gassner said the company’s initial focus is on life-sciences sponsors, though service providers have also expressed interest. He said Falcon could eventually be used by outsourced service providers, but Veeva is prioritizing sponsor use cases first. On regulatory requirements, Gassner said agentic labor is non-deterministic and therefore requires training and guardrails similar to those used for human workers. Falcon includes human-in-the-loop capabilities that let users review an agent’s work within a Vault application, he said. Management did not provide detailed Falcon pricing. Gassner said customers want predictable costs, and Veeva could use enterprise subscription agreements based on the size of a customer or its functional organization. Pricing could increase as Falcon’s capabilities mature, he added. Gassner said he expects Falcon’s gross margins to be broadly similar to Veeva’s software margins over time. He said Veeva is placing more functionality in deterministic software layers and expects AI-model costs to decline over time through hardware improvements, open-weight models or other technology advances. Van Wagener said Veeva’s R&D business is in the middle of a transition from established products toward newer growth offerings. Earlier growth was supported by products including eTMF, CTMS, QualityDocs, Veeva QMS and the company’s regulatory suite. Looking further out, Veeva sees growth opportunities in Veeva EDC, eCOA, RTSM, Safety and LIMS. Van Wagener described each as a large and strategic market opportunity, though all remain relatively early in their development cycles. He said the timing of their growth curves does not align exactly, which is reflected in the company’s outlook for the rest of the fiscal year. Gassner said Veeva has EDC relationships with nine of the top 20 biopharma companies. He characterized EDC implementations as long-cycle projects and said the company expects continued progress over the next several years. Veeva is also expanding its clinical portfolio with site solutions and eSource capabilities. Veeva also discussed Aspen, its emerging horizontal CRM initiative. Gassner called Aspen a startup within Veeva, operating with small investment levels and focused on early customers and rapid product iteration. He said the company is targeting nimble technology startups initially and is confident there is demand for a new approach to horizontal CRM. Aspen’s public pricing model is designed to be simpler and more predictable than traditional enterprise software pricing, according to Gassner. The company has discussed a price of $50 per user per month, with potential overage charges for unusual levels of data storage or compute usage. Gassner said Aspen aims to address concerns around unpredictable pricing, vendor dependability, scalability, heavy data-entry requirements and lengthy CRM implementations. He said AI could reduce much of the data entry required in existing CRM systems. In Data Cloud, Veeva said OpenData, Compass and Link are key areas of progress. Gassner described OpenData as clean reference data, Compass as particularly useful in certain complex-therapy markets, and Link as a market-leading product with expansion opportunities in medical insights, key accounts and congress workflows. While data products tend to grow gradually, he said they are strategically valuable because they work alongside Veeva’s applications, consulting services and AI agents. Management also said its partnership with IQVIA has been productive. Gassner said customers appreciate reduced friction in working with the two companies and that greater collaboration across software, data and services could benefit the life-sciences industry. Veeva Systems (NYSE: VEEV) is a cloud software company that develops industry-specific applications and data solutions for the global life sciences sector. Founded in 2007 and headquartered in Pleasanton, California, Veeva focuses on helping pharmaceutical, biotechnology, medical device and consumer health companies manage regulated content, clinical and regulatory processes, quality systems, and commercial operations in a compliant, cloud-native environment. The company completed its initial public offering in 2013 and has since expanded its product suite and international footprint. Veeva's product portfolio centers on its Vault platform and related application suites, which provide content and data management, clinical trial and regulatory workflows, quality management, and structured commercial capabilities such as customer relationship management and promotional content management. 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 "Veeva Systems Q2 Earnings Call Highlights" was originally published by MarketBeat. View MarketBeat's top stocks for August 2026.

MELBOURNE, Australia and INDIANAPOLIS, Aug. 20, 2026 (GLOBE NEWSWIRE) -- Telix Pharmaceuticals Limited (ASX: TLX, NASDAQ: TLX, "Telix") today announces its financial results for the period ended June 30, 2026. H1 2026 key results Group performance1: Double-digit revenue growth and gross margin improvement Group revenue of US$477 million, up 22%2 year-over-year, tracking in line with the upper end of full year guidance of US$950 million to US$970 million. Group gross margin of 55%, up 2% year-over-year, Precision Medicine gross margin of 65%, up 1% year-over-year, reflecting solid commercial performance, a favorable product mix and operational efficiencies. Adjusted EBITDA3 of US$52 million, up 146% year-over-year reflecting strong demand across our product portfolio and initial non-refundable payment of US$40 million from Regeneron collaboration4. Research & Development (R&D) investment of US$124 million, primarily directed toward advancing late-stage therapeutic and precision medicine programs, supporting the Company's strategy to build diversified revenue streams. Entered into strategic collaboration with Regeneron to jointly develop and commercialize next generation radiopharmaceutical therapies4. Completed refinancing of existing convertible bond structure, issuing US$600 million of new convertible bonds due 20315. Profit after tax of US$38 million includes US$40 million of other income received from Regeneron and finance costs of US$19 million, predominately related to refinancing of the convertible bonds. Generated positive operating cash flow of US$23 million and maintained a cash balance of US$252 million as of June 30, 2026. Executive commentary Managing Director and Group CEO, Dr. Christian Behrenbruch, stated: “Telix delivered an outstanding first half, with strong revenue growth, market share gains and significant progress across clinical and regulatory milestones. Our strengthened balance sheet is enabling increased investment in late-stage programs, including ProstACT Global, market expansion opportunities within our precision medicine portfolio and manufacturing and supply chain capabilities that differentiate Telix. With multiple near-term catalysts, we enter the second half with strong momentum and confidence.” Segment results Telix Precision Medicine: Strong volume growth of Illuccix® and Gozellix® Precision Medicine segment revenue up by 27% year-over-year reflecting continued success of Telix’s two product strategy, with Illuccix® and Gozellix® delivering growth in sales volumes and market share gains. Gross margin of 65% up 1% year-over-year. Adjusted (segment) EBITDA up by 26% year-over-year to US$132 million. Patient enrollment nearing completion for Phase 3 BiPASS™ study of Illuccix and Gozellix for prostate cancer imaging in the pre-biopsy setting. Illuccix Japan Phase 3 registrational study enrollment completion6. New drug application (NDA) for Illuccix accepted and under review by the Chinese National Medical Products Administration (NMPA) Center for Drug Evaluation (CDE)7. TLX101-Px, (floretyrosine F 18) for glioma (brain cancer) imaging: TLX250-Px, Zircaix®8 (zirconium-89 (89Zr) girentuximab senvedoxam) for kidney cancer imaging: Telix continues to make good progress toward near-term resubmission of its U.S. Biologics License Application (BLA). The Company has been granted an extension of the BLA resubmission deadline, following receipt of a corrected Complete Response Letter (CRL)12. Telix continues to work closely with the FDA to ensure the resubmission package comprehensively addresses all outstanding CRL items. Telix Therapeutics: Investment delivering significant advances across a number of key late-stage development programs Of the R&D investment, US$68 million was invested in the therapeutics pipeline. Milestones include: TLX591-Tx (lutetium (177Lu) rosopatamab tetraxetan): TLX597-Tx (177Lu-DOTA-HYNIC-panPSMA): TLX250-Tx (lutetium (177Lu) girentuximab tetraxetan): TLX101-Tx (iodofalan 131I): Telix Manufacturing Solutions (TMS): Expanding Telix’s global footprint to enable next phase of growth Telix continues to invest in its global infrastructure, expanding its TMS operations. The TMS segment includes RLS Radiopharmacies (RLS), IsoTherapeutics (U.S.), and production (and R&D) facilities in Sacramento (U.S.), Seneffe (Belgium), North Melbourne (Australia) and Yokohama (Japan), representing a significantly expanded global production and manufacturing footprint. TMS is central to Telix's long-term growth strategy and is expected to support increasing commercial demand and future pipeline expansion. TMS reported US$146 million total segment revenue, which includes US$89 million from third-party product sales and service fees, and US$58 million internal revenue20, reflecting growth in sales of Illuccix and Gozellix through the RLS network and contributing to Group gross margin improvement. TMS operating loss of US$33 million, includes US$10 million of depreciation and amortization on acquired intangibles. Adjusted EBITDA loss for the TMS segment of US$23 million (H1 2025: Adjusted EBITDA loss of US$13 million), driven by increased investment in supply chain and logistics functions to meet anticipated therapeutics infrastructure needs. Other TMS milestones in H1 2026 include: Guidance FY 2026 revenue and other income expected to be in excess of US$1 billion, with revenue progressing in line with upper end of FY 2026 guidance of US$950 million to US$970 million and US$40 million of other income received from Regeneron. Telix reaffirms R&D expenditure guidance of US$230 million to US$270 million, enabled by the Company’s strong commercial performance and initial payment of US$40 million received from Regeneron. Corporate update The Company advises that on August 20, 2026, it entered into an equity distribution agreement (EDA) with Morgan Stanley & Co. LLC and William Blair & Company, L.L.C. (together, the "Sales Agents") to establish an "at-the-market" (ATM) facility. Under the ATM facility, the Company may, from time to time, determine to offer and issue new fully paid ordinary shares ("Shares") at prevailing market prices in the form of American Depository Shares (ADSs). Each ADS represents one Share. The ATM facility will provide an opportunity to facilitate greater access to the Company’s securities on the Nasdaq stock exchange. The Company will control the offer process and has sole discretion over whether and when the ATM facility is used, the number of ADSs sold, and the minimum sale price of the ADSs. No offers or sales of ADSs will be made under the ATM facility unless and until a prospectus supplement has been filed with the U.S. Securities and Exchange Commission (SEC). The ATM facility will be subject to compliance with the ASX Listing Rules, including the Company’s available share placement capacity. Summary: Group financial results Investor call An investor webcast and conference call will be held at 9:00 a.m. AEST today, Thursday, August 20, 2026 (7:00 p.m. EDT Wednesday, August 19, 2026). Participants can register for the webcast via this link: https://s1.c-conf.com/diamondpass/10056417-pz2402.html About Telix Pharmaceuticals Limited Telix Pharmaceuticals (ASX: TLX, NASDAQ: TLX) is a commercial-stage global radiopharmaceutical company, advancing targeted theranostics to improve outcomes for people with cancer across the patient journey. Theranostics pairs a precision diagnostic with a targeted therapy to both diagnose and treat disease. Telix's commercial franchise is anchored by its prostate cancer imaging portfolio: Illuccix® (kit for the preparation of gallium-68 gozetotide injection), commercially available in 22 countries including the U.S. and Gozellix® (kit for the preparation of gallium-68 gozetotide injection), approved by the U.S. Food and Drug Administration (FDA). The Company's late-stage therapeutic pipeline includes three investigational assets in pivotal-stage trials: TLX591-Tx (lutetium-177 (177Lu) rosopatamab tetraxetan) in prostate cancer, TLX101-Tx (131I-iodofalan) in recurrent glioblastoma, and TLX250-Tx (lutetium (177Lu) girentuximab tetraxetan) in kidney cancer, additionally complemented by a deep pipeline of next generation candidates. Telix is headquartered in Melbourne, Australia, with operations across North America, Europe, Latin America and Asia-Pacific. For more information, visit www.telixpharma.com or follow Telix on LinkedIn, X and Facebook. Investor Relations Annie Kasparian [email protected] Charlene [email protected] Guidance Disclaimer The stated guidance is based on expected global and domestic economic conditions and is subject to known and unknown risks, uncertainties and other factors that may cause our actual results to differ materially. As such, investors are cautioned not to place undue reliance on this guidance and in particular Telix cannot guarantee a particular result. In compiling financial forecasts, a number of key variables that may have a significant impact on guidance have been identified and are listed below. Key variables that could cause actual results to differ materially include: the success and timing of research and development activities; decisions by regulatory authorities regarding approval of our products as well as their decisions regarding label claims; competitive developments affecting our products; the ability to successfully market new and existing products; difficulties or delays in manufacturing; trade buying patterns and fluctuations in interest and currency exchange rates; legislation or regulations that affect product production, distribution, pricing, reimbursement, access or tax; acquisitions and divestitures; research collaborations; litigation or government investigations; and Telix’s ability to protect its patents and other intellectual property. This announcement has been authorized for release by the Telix Pharmaceuticals Limited Board of Directors No Offer or Solicitation This announcement does not constitute an offer to sell or the solicitation of an offer to buy any securities, nor shall there be any sale of any securities of the Company in any jurisdiction in which such offer, solicitation, or sale would be unlawful prior to registration or qualification under the securities laws of any such jurisdiction. No offers or sales of ADSs will be made under the EDA unless and until a prospectus supplement has been filed with the SEC. Telix has filed an automatic shelf registration statement on Form F-3ASR (File No. 333-293611) with the SEC, which became immediately effective upon filing. Any offering of securities in connection with the at-the-market offering will be made only by means of a prospectus supplement and the accompanying prospectus that form a part of the registration statement. A prospectus supplement describing the terms of the at-the-market offering will be filed with the SEC prior to any sales of ADSs under the EDA. When available, copies of the prospectus supplement and the accompanying base prospectus may be obtained from: Morgan Stanley & Co. LLC Attention: Prospectus Department 180 Varick Street, 2nd Floor New York, NY 10014 and William Blair & Company, L.L.C. Attention: Prospectus Department 150 North Riverside Plaza Chicago, IL 60606 or by accessing the SEC's website at www.sec.gov. The at-the-market facility will be subject to the ASX Listing Rules framework for share issuances, including applicable placement and participation limits. Legal Notices You should read this announcement together with our risk factors, as disclosed in our most recently filed reports with the Australian Securities Exchange (ASX), U.S. Securities and Exchange Commission (SEC), including our Annual Report on Form 20-F filed with the SEC, or on our website. The information contained in this announcement is not intended to be an offer for subscription, invitation or recommendation with respect to securities of Telix Pharmaceuticals Limited (Telix) in any jurisdiction, including the United States. The information and opinions contained in this announcement are subject to change without notification. To the maximum extent permitted by law, Telix disclaims any obligation or undertaking to update or revise any information or opinions contained in this announcement, including any forward-looking statements (as referred to below), whether as a result of new information, future developments, a change in expectations or assumptions, or otherwise. No representation or warranty, express or implied, is made in relation to the accuracy or completeness of the information contained or opinions expressed in the course of this announcement. This announcement may contain forward-looking statements, including within the meaning of the U.S. Private Securities Litigation Reform Act of 1995, that relate to anticipated future events, financial performance, plans, strategies or business developments. Forward-looking statements can generally be identified by the use of words such as “may”, “expect”, “intend”, “plan”, “estimate”, “anticipate”, “believe”, “outlook”, “forecast” and “guidance”, or the negative of these words or other similar terms or expressions. Forward-looking statements involve known and unknown risks, uncertainties and other factors that may cause our actual results, levels of activity, performance or achievements to differ materially from any future results, levels of activity, performance or achievements expressed or implied by these forward-looking statements. Forward-looking statements are based on Telix’s good-faith assumptions as to the financial, market, regulatory and other risks and considerations that exist and affect Telix’s business and operations in the future and there can be no assurance that any of the assumptions will prove to be correct. In the context of Telix’s business, forward-looking statements may include, but are not limited to, statements about: the initiation, timing, progress, completion and results of Telix’s preclinical and clinical trials, and Telix’s research and development programs; Telix’s ability to advance product candidates into, enroll and successfully complete, clinical studies, including multi-national clinical trials; the timing or likelihood of regulatory filings and approvals for Telix’s product candidates, including TLX101-Px and TLX250-Px, manufacturing activities and product marketing activities; Telix’s sales, marketing and distribution and manufacturing capabilities and strategies; the commercialization of Telix’s product candidates, if or when they have been approved; Telix’s ability to obtain an adequate supply of raw materials at reasonable costs for its commercial products and product candidates; estimates of Telix’s expenses, future revenues and capital requirements; Telix’s financial performance; developments relating to Telix’s competitors and industry; the anticipated impact of U.S. and foreign tariffs and other macroeconomic conditions on Telix’s business, including as a result of war or other geopolitical conflicts; and the pricing and reimbursement of Telix’s product candidates, if and after they have been approved. Forward-looking statements may also include statements about the timing and use of the at-the-market facility established under the EDA, the potential sale of ADSs therefrom, Telix's intentions regarding activation of the at-the-market facility, and the anticipated benefits of the at-the-market facility. Telix’s actual results, performance or achievements may be materially different from those which may be expressed or implied by such statements, and the differences may be adverse. Accordingly, you should not place undue reliance on these forward-looking statements. Non-IFRS Financial Measures. Telix’s results are reported under International Financial Reporting Standards (IFRS). This announcement includes various non-IFRS financial information to reflect its underlying performance, which have not been subject to audit or review. These non-IFRS measures include Adjusted EBITDA, which represents net earnings attributable to the Group excluding net finance costs, income tax expense, depreciation and amortization and other gains/(losses) (net). As required by SEC rules, we have provided reconciliations of these non-IFRS financial measures to the most directly comparable IFRS measures, which for Adjusted EBITDA, is Profit/(loss) before income tax. The Group believes that these non-IFRS measures, which are not considered to be a substitute for or superior to IFRS measures, provide stakeholders with additional useful information on the underlying trends, performance and position of the Group and are consistent with how business performance is measured internally. The non-IFRS measures are not defined by IFRS and therefore may not be directly comparable with other companies’ alternative performance measures. Trademarks and Trade Names. All trademarks and trade names referenced in this press release are the property of Telix Pharmaceuticals Limited (Telix) or, where applicable, the property of their respective owners. For convenience, trademarks and trade names may appear without the ® or ™ symbols. Such omissions are not intended to indicate any waiver of rights by Telix or the respective owners. Trademark registration status may vary from country to country. Telix does not intend the use or display of any third-party trademarks or trade names to imply any affiliation with, endorsement by, or sponsorship from those third parties. ©2026 Telix Pharmaceuticals Limited. All rights reserved. 1 Group performance includes Telix Precision Medicine, Telix Therapeutics and Telix Manufacturing Solutions (TMS).2 All comparisons to H1 2025 results.3 Earnings before interest, tax, depreciation and amortization.4 Telix ASX disclosure April 13, 2026.5 Telix ASX disclosure April 14, 2026.6 Telix media release July 17, 2026. Japan Registry of Clinical Trials identifier: JRCT2031250473.7 Telix media release January 20, 2026.8 Launch and brand names subject to final regulatory approval. Zircaix (TLX250-Px, ccRCC imaging), Pixclara and Pixlumi (TLX101-Px, glioma imaging). 9 Prescription Drug User Fee Act.10 Telix ASX disclosure April 10, 2026.11 Telix media release May 1, 2026.12 Corrected CRL issued April 10, 2026.13 Telix ASX disclosure March 10, 2026.14 Telix ASX disclosure July 2, 2026.15 Telix LinkedIn June 25, 2026. Australian New Zealand Clinical Trials Registry ID: ACTRN12625000971437. 16 Telix media release July 16, 2026. Australian New Zealand Clinical Trials Registry ID: ACTRN12626000034336.17 Telix media release July 21, 2026. ClinicalTrials.gov ID: NCT07197580. Clear cell renal cell carcinoma.18 ClinicalTrials.gov ID: NCT07100730.19 ClinicalTrials.gov ID: NCT05450744.20 Inter-segment revenue is eliminated on consolidation, refer to note 3 of the Interim financial report lodged today with the ASX.21 Earnings before interest, tax, depreciation and amortization and other gains/(losses) (net).

Advanced zolucatetide across multiple Wnt/β-catenin-driven diseases, including progress toward planned Phase 3 registrational trial in desmoid tumors Announced strategic research collaboration with Regeneron to develop Antibody-Helicon Conjugates, expanding application of company's proprietary HeliconTM platform; received $125M in upfront consideration and equity investment, with the potential for up to $2.2B in milestone payments plus tiered royalties Ended the second quarter with a strong financial position with $1.1B in cash, cash equivalents and marketable securities, following completion of $770.5M initial public offering and other transactions, expected to fund operations into 2030 CAMBRIDGE, Mass., Aug. 13, 2026 (GLOBE NEWSWIRE) -- Parabilis Medicines (Nasdaq: PBLS), a clinical-stage biopharmaceutical company dedicated to creating extraordinary medicines for patients with serious diseases by unlocking historically undruggable targets, today reported financial results and business updates for the second quarter ended June 30, 2026. “This quarter marked meaningful progress toward our long-term vision as we continued advancing zolucatetide across multiple Wnt/β-catenin-driven diseases, including toward planned registrational development in desmoid tumors, while also extending the reach of our Helicon™ platform through our strategic research collaboration with Regeneron focused on developing Antibody-Helicon Conjugates," said Mathai Mammen, M.D., Ph.D., Chairman, President and Chief Executive Officer of Parabilis Medicines. Dr. Mammen continued, "The body of encouraging clinical evidence for zolucatetide has strengthened our conviction both in its potential to transform the treatment of patients with Wnt/β-catenin-driven diseases and in the broader ability of Helicons to unlock biologically important intracellular targets that have historically been beyond the reach of conventional therapeutic approaches. With a strong balance sheet following our successful initial public offering, we believe we are well positioned to deliver important clinical and regulatory milestones over the coming quarters as we continue advancing medicines designed to target the causal biology and deliver meaningful impact for patients with serious diseases." Recent Business Highlights & Anticipated Milestones Continued Advancement of ZolucatetideZolucatetide is Parabilis' lead investigational Helicon and the first and only direct inhibitor of the β-catenin:TCF interaction in clinical development. The investigational therapy is being evaluated as a “pipeline in a product” across multiple Wnt/β-catenin-driven diseases, with promising early clinical data demonstrating its potential in desmoid tumors, with familial adenomatous polyposis (FAP) and adamantinomatous craniopharyngioma (ACP) as potential genetically anchored expansion opportunities. Desmoid tumors Abstract accepted for oral presentation at the European Society for Medical Oncology (ESMO) Congress 2026 (Oct. 23-27, Madrid), with a plan to share clinical data from the February data cut from the ongoing Phase 1/2 study of zolucatetide in desmoid tumor patients Expect to present more mature clinical data from the ongoing Phase 1/2 study in desmoid tumors during the fourth quarter of 2026 Expect to engage with the U.S. Food and Drug Administration (FDA) during the fourth quarter of 2026 to discuss and align on the planned registrational Phase 3 trial On track to initiate Phase 3 registrational trial in the first half of 2027 Familial adenomatous polyposis (FAP) Expect to initiate enrollment in a dedicated clinical cohort evaluating zolucatetide in patients with FAP during the second half of 2026 Anticipate disclosing additional FAP data in the first quarter of 2027 Adamantinomatous craniopharyngioma (ACP) Expect to share clinical data from additional patients in the first half of 2027 for ACP, a locally aggressive tumor arising near the pituitary gland associated with significant lifelong morbidity and no approved drug therapies, with a conservatively estimated 15-year prevalence of approximately 5,000 to 9,000 patients in the U.S. Additional Wnt-driven tumors Continue to enroll patients across additional cohorts evaluating zolucatetide across additional indications with high unmet medical need, including hepatocellular carcinoma (HCC), colorectal cancer (CRC) in rational combinations, and other Wnt-driven solid tumors Correspondence published in the New England Journal of Medicine (NEJM) demonstrates durable clinical and radiologic response to zolucatetide in a patient with recurrent ameloblastoma – a locally aggressive tumor of the jaw – driven by Wnt/β-catenin pathway alterations, providing further clinical validation of zolucatetide's mechanism of action Expanded the Application of the Helicon PlatformDuring the second quarter of 2026, Parabilis continued to expand the reach of its proprietary Helicon platform through strategic partnerships and advancement of its wholly-owned discovery pipeline. Announced a strategic collaboration with Regeneron Pharmaceuticals, Inc. focused on developing Antibody-Helicon Conjugates (AHCs), a novel therapeutic modality combining Regeneron's VelocImmune® antibody technologies with Parabilis' proprietary Helicon platform to selectively target undruggable and challenging intracellular disease-driving proteins; Parabilis received $125 million, including $50 million in upfront consideration and a $75 million equity investment, and the collaboration provides the potential for up to approximately $2.2 billion in development, regulatory and commercial milestone payments, plus up to low double-digit tiered royalties Continued advancing multiple wholly owned Helicon-based preclinical programs targeting historically undruggable intracellular proteins, including ERG and allosteric ARON degraders in prostate cancer and a β-catenin degrader program Strengthened Leadership and GovernanceParabilis continued to strengthen its leadership team and Board of Directors to support the Company's next phase of growth as a public company. Expanded the Company’s executive leadership team through the appointments of Helen Ho, Ph.D., as Chief Business & Strategy Officer, and Tom Kotarakos as Chief Financial Officer Appointed Alan M. Sebulsky to the Board of Directors, bringing more than three decades of biopharmaceutical finance and operational leadership experience Completed Initial Public OfferingDuring the quarter, Parabilis successfully completed its upsized initial public offering, raising a total of $770.5 million (before offering expenses), strengthening the Company's balance sheet to support the continued advancement of its clinical pipeline and proprietary Helicon™ platform. Closed upsized initial public offering of common stock, including the full exercise of the underwriters' option to purchase additional shares, at an initial public offering price of $20.00 per share Completed a concurrent private placement with Regeneron resulting in gross proceeds of approximately $75 million Began trading on the Nasdaq Global Select Market under the ticker symbol "PBLS" on June 10, 2026 Second Quarter Financial ResultsCash position: Cash, cash equivalents and marketable securities were $1.1 billion as of June 30, 2026, compared to $27.7 million as of December 31, 2025. The Company's cash, cash equivalents and marketable securities as of June 30, 2026 are expected to fund its operations into 2030. R&D expenses: Research and development expenses were $39.4 million for the quarter ended June 30, 2026, compared to $30.1 million for the comparable prior year period. The increase of $9.3 million was primarily driven by ongoing investment in the clinical development of zolucatetide across a number of indications, increased employee-related costs (including stock-based compensation) associated with increased hiring to support the advancing clinical pipeline, and progression of the Company’s preclinical β-catenin, ERG, and ARON degrader programs. G&A expenses: General and administrative expenses were $11.7 million for the quarter ended June 30, 2026, compared to $6.4 million for the comparable prior year period. The increase of $5.3 million was primarily due to higher employee-related costs (including stock-based compensation) related to increased hiring to support the Company's growth as it advances its clinical programs, and expenses associated with operating as a public company. Net loss: Net loss was $52.5 million for the quarter ended June 30, 2026, compared to $34.8 million for the comparable prior year period. The increase in net loss of $17.7 million was primarily driven by increased operating expenses. About Parabilis Medicines Parabilis Medicines (Nasdaq: PBLS) is a clinical-stage biopharmaceutical company dedicated to creating extraordinary medicines for patients with serious diseases by unlocking biologically important targets long considered undruggable. The company has pioneered a new class of alpha-helical peptides – Helicons™ – capable of modulating intracellular proteins that have historically been beyond the reach of conventional medicines. The company’s lead investigational medicine, zolucatetide, is the first and only direct inhibitor of the β-catenin:TCF interaction, a central node in the Wnt/β-catenin pathway that has eluded drug developers for decades. Zolucatetide is being evaluated in the clinic across multiple Wnt/β-catenin-driven diseases, including desmoid tumors, familial adenomatous polyposis (FAP), adamantinomatous craniopharyngioma (ACP) and a range of other solid tumor indications. Beyond zolucatetide, Parabilis is advancing additional Helicon-based programs focused on other challenging targets where we believe our medicines could have life-altering impact. For more information, visit www.parabilismed.com or follow us on LinkedIn. Forward-Looking StatementsThis press release contains “forward-looking statements” within the meaning of Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934, each as amended. The words “anticipate,” “believe,” “continue,” “could,” “estimate,” “expect,” “intend,” “may,” “plan,” “potential,” “predict,” “project,” “should,” “target,” “would” and similar expressions are intended to identify forward-looking statements, although not all forward-looking statements contain these identifying words. These forward-looking statements include, but are not limited to, express or implied statements regarding: the clinical development of zolucatetide for the treatment of desmoid tumors, FAP, ACP and other rare, Wnt-driven tumors, including the initiation, timing, progress, results and future data releases of our ongoing and planned clinical trials; the expected initiation and timing of the Company’s planned Phase 3 registrational trial in desmoid tumors; the expected timing and results of the ongoing Phase 1/2 study in desmoid tumors; the expected enrollment and timing of certain patient cohorts in Wnt-driven tumors; the expected timing and results of and anticipated payments under the Company’s collaboration agreement with Regeneron; the expected timing and results of the Company’s preclinical development of its ERG degrader, ARON degrader and β-catenin degrader development candidates; the potential of the Company’s Helicon™ technology platform; expectations regarding the development of any future product candidates using the Company’s Helicon™ technology platform; expectations regarding the efficacy, tolerability, and commercial potential of zolucatetide; and expectations for the Company’s uses of capital, expenses and financial results, including its cash runway into 2030. Any forward-looking statements in this press release are based on management’s current expectations and beliefs and are subject to a number of risks and uncertainties that could negatively affect the Company’s business, operating results, financial condition and stock value. Factors that could cause actual events or results to differ materially from those expressed or implied by any forward-looking statements contained in this press release include, without limitation: risks relating to the Company’s research and development activities; the Company’s ability to execute on its strategy including obtaining the requisite regulatory approvals on the expected timeline, if at all; uncertainties relating to preclinical and clinical development activities; the Company’s dependence on third parties to conduct clinical trials, manufacture its product candidates and develop and commercialize its product candidates, if approved; the Company’s ability to attract, integrate and retain key personnel; risks related to the Company’s financial condition and need for substantial additional funds in order to complete development activities and commercialize a product candidate, if approved; risks related to regulatory developments and approval processes of the U.S. Food and Drug Administration and comparable foreign regulatory authorities; risks related to establishing and maintaining the Company’s intellectual property protections; and risks related to the competitive landscape for the Company’s product candidates; as well as other risks and uncertainties described in greater detail in “Risk Factors,” in the Company’s most recent Quarterly Report on Form 10-Q, as well as discussions of potential risks, uncertainties, and other important factors in the Company’s subsequent filings with the Securities and Exchange Commission. Any forward-looking statements represent the Company’s views only as of today and should not be relied upon as representing its views as of any subsequent date. The Company expressly disclaims any obligation or undertaking to release publicly any updates or revisions to any forward-looking statements contained herein to reflect any change in its expectations or any changes in events, conditions or circumstances on which any such statement is based, except as required by law, and claims the protection of the safe harbor for forward-looking statements contained in the Private Securities Litigation Reform Act of 1995. Media ContactJessica [email protected] Contact: Tom [email protected]

Interested in CytomX Therapeutics, Inc.? Here are five stocks we like better. Varseta-M remains CytomX’s primary focus: The Phase I monotherapy study has enrolled 113 patients, with a broader clinical update expected by the end of 2026 and a potential registrational study planned for the first half of 2027. CytomX is expanding Varseta-M into earlier-line colorectal cancer through combinations with bevacizumab, 5-fluorouracil and leucovorin, while also launching Phase I cohorts in gastric, pancreatic and biliary tract cancers. Financially, the company reported $330.3 million in cash and investments at June 30 and received a subsequent $37 million Regeneron payment, extending its expected cash runway into at least the second half of 2028 despite lower quarterly revenue and higher operating expenses. CytomX Therapeutics (NASDAQ:CTMX) said its second-quarter focus remained on advancing Varseta-M, an EpCAM-targeting antibody-drug conjugate being developed for metastatic colorectal cancer, while expanding the program into combination regimens and additional gastrointestinal cancers. Chief Executive Officer and Chairman Sean McCarthy said the company has enrolled 113 patients in its overall Phase I Varseta-M monotherapy study, spanning dose escalation, expansion and optimization cohorts. Enrollment in dose optimization was completed in April, with 40 patients enrolled across 8.6 mg/kg and 10 mg/kg dose levels using adjusted ideal body weight dosing. → 3 Drone Stocks That Should Soar After the Summer Slump The company plans to provide a Phase I update by the end of 2026 covering the broader 113-patient study. The update is expected to focus on dose selection for monotherapy and support planning for a first registrational study, which CytomX aims to begin in the first half of 2027. McCarthy said CytomX continues to view both third-line and fourth-line colorectal cancer as potential settings for Varseta-M’s initial registrational study, with the eventual decision depending on emerging clinical data. The company expects to communicate its strategy later in 2026. → Meta’s Earnings Drop Shows Wall Street Wants More Than Ad Growth During the question-and-answer session, McCarthy said the company expects its year-end update to include a preliminary progression-free survival assessment from the dose-optimization cohorts, as well as an initial look at overall survival from patients in the dose-escalation and expansion portions of the study. He said CytomX’s baseline assumption is that overall survival would serve as the primary endpoint in a late-line colorectal cancer registrational study. Potential comparators would differ by treatment setting. In fourth-line disease, the company is evaluating options including fruquintinib, regorafenib or physician’s choice, while a third-line study would most likely use bevacizumab plus LONSURF as a comparator, McCarthy said. → Jersey Mike's Serves Fresh Gains After IPO Stumble McCarthy cited benchmarks discussed on the call for late-line treatments, including low-single-digit response rates and several months of progression-free survival in fourth-line disease. For third-line bevacizumab plus LONSURF, he referenced progression-free survival of roughly 4.5 to 5.5 months and overall survival of nine to 10 months. CytomX previously reported preliminary progression-free survival of 6.8 to 7.1 months at the 8.6 mg/kg and 10 mg/kg dose levels in March. CytomX is also evaluating Varseta-M in combination with bevacizumab, a component of colorectal cancer treatment regimens across earlier and later lines of therapy. The ongoing Phase I cohort is studying every-two-week and every-four-week schedules designed to align with bevacizumab treatment schedules. The company is continuing to enroll late-line patients in the bevacizumab combination study and expects to move toward earlier-line patients after selecting a go-forward dose and schedule. Initial clinical data are expected in the first half of 2027. McCarthy said the company is using the same loperamide and budesonide prophylaxis strategy in the bevacizumab combination cohort as in monotherapy dose optimization. He said CytomX had previously reported that grade 3 diarrhea after the first several months of prophylaxis experience had been reduced to 10%. The company plans to initiate another Phase I/II study in the fourth quarter that will evaluate escalating Varseta-M doses in combination with bevacizumab, 5-fluorouracil and leucovorin in second-line colorectal cancer. CytomX said the study is intended to support its goal of replacing irinotecan with Varseta-M in earlier-line therapy. McCarthy said all patients treated with Varseta-M to date have received irinotecan as part of their treatment history because they were in late-line settings. The planned second-line combination study is expected to help the company gain experience with Varseta-M in irinotecan-naive patients over time. CytomX announced plans to initiate Phase I expansion cohorts for Varseta-M in gastric and gastroesophageal junction cancer, pancreatic ductal adenocarcinoma and biliary tract cancer. The company plans to enroll about 20 patients in each tumor type to evaluate antitumor activity and safety before determining potential next steps. The company expects to enroll an unselected population in gastric and gastroesophageal junction cancer because of the expected prevalence of EpCAM expression. It plans to screen pancreatic and biliary tract cancer patients for EpCAM expression. McCarthy said EpCAM is expressed at some level in nearly all pancreatic and biliary tract cancer patients based on published literature and the company’s studies using its immunohistochemistry assay. He said approximately 50% to 60% of patients may be considered EpCAM-high, depending on the definition, though CytomX has not disclosed its cutoff for high expression. “We think it makes sense to at least start” with higher EpCAM-expressing patients in pancreatic and biliary tract cancers, McCarthy said, while noting the company is still learning about the relationship between EpCAM levels and Varseta-M activity. CytomX also reported progress for CX-801, its masked interferon alfa-2b program in checkpoint-refractory melanoma. The monotherapy portion of the Phase I study has reached its fourth dose level, while the combination study with KEYTRUDA has cleared its third dose level and continues enrollment. McCarthy said CX-801 monotherapy has been generally well tolerated to date, including at doses exceeding levels achieved with commercially available unmasked interferon alfa-2b. Initial clinical data from the melanoma study are expected in the first half of 2027. During the quarter, CytomX announced an expanded collaboration with Regeneron focused on next-generation masked bispecific immunotherapies. Chief Financial Officer Chris Ogden said CytomX received a $37 million payment from Regeneron in July after the selection of two additional targets under the collaboration. Ogden said the payment was not included in CytomX’s June 30 cash balance and will be recognized as revenue over time as work is performed on the preclinical programs. Cash, cash equivalents and investments totaled $330.3 million as of June 30, compared with $346.7 million as of March 31. The June 30 balance did not include the $37 million July payment from Regeneron. Ogden said pro forma cash was about $367 million after that payment. Total revenue was $1.4 million, down from $18.7 million in the second quarter of 2025, primarily due to the conclusion of the Bristol Myers Squibb collaboration in 2025 and the Astellas collaboration in the first half of 2026. Operating expenses increased to $25.2 million from $19.9 million a year earlier. Research and development expense rose to $17.6 million, driven primarily by Varseta-M manufacturing, personnel costs and other research and development expenses. General and administrative expense increased to $7.6 million from $6.6 million, primarily because of higher consulting costs. Ogden said CytomX expects its existing balance sheet to provide cash runway into at least the second half of 2028, supporting its planned registrational study for Varseta-M, earlier-line combination development and expansion into other EpCAM-expressing cancers. CytomX Therapeutics, Inc is a clinical-stage biopharmaceutical company focused on the discovery and development of next-generation therapeutics based on its proprietary Probody® platform. The company engineers masked antibody prodrugs that remain inactive in healthy tissue but are selectively activated in the tumor microenvironment. This approach is designed to enhance the safety and tolerability of antibody-based therapies, particularly those targeting immuno-oncology pathways. At the core of CytomX's pipeline is Pacmilimab (CX-072), an anti–PD-L1 Probody therapeutic currently undergoing clinical evaluation for multiple solid tumor indications. 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 "CytomX Therapeutics Q2 Earnings Call Highlights" was originally published by MarketBeat. View MarketBeat's top stocks for August 2026.

Intellia Therapeutics NTLA incurred a second-quarter 2026 loss of 80 cents per share, in line with the Zacks Consensus Estimate. The loss narrowed 18.4% from the loss of 98 cents per share in the year-ago quarter. Intellia’s total revenues currently comprise only collaboration revenues. The company reported revenues of $7.7 million, which missed the Zacks Consensus Estimate of $15 million. Revenues declined 46.2% year over year, reflecting lower collaboration revenues from Regeneron Pharmaceuticals REGN. Research and development expenses declined 14.9% year over year to $82.6 million. The decrease was due to lower external costs related to Intellia’s lead development programs, lonvo-z and nex-z, and lower stock-based compensation, partly offset by higher employee-related expenses due to increased headcount. General and administrative expenses increased 39% year over year to $37.8 million. The increase was primarily driven by costs associated with the ongoing buildout of Intellia's commercial infrastructure, higher legal expenses and stock-based compensation. As of June 30, 2026, Intellia had cash, cash equivalents and marketable securities worth $628.4 million compared with $517.2 million as of March 31, 2026. Following the completion of an underwritten public offering of common stock in April, which generated approximately $195 million in net proceeds, the company expects its existing cash resources to fund operations at least into 2028 and well beyond the anticipated U.S. commercial launch of lonvo-z for hereditary angioedema (HAE) in the first half of 2027. Year to date, shares of NTLA have surged 25% compared with the industry’s 3.6% growth. Image Source: Zacks Investment Research Intellia continued to advance lonvoguran ziclumeran (lonvo-z) for HAE. The phase III HAELO study met its primary endpoint and all key secondary endpoints, with a one-time infusion reducing attacks by 87% compared with placebo over the six-month efficacy evaluation period. NTLA expects the FDA to accept its biologics license application for lonvo-z to treat HAE in the second half of 2026. If approved, Intellia plans a U.S. commercial launch in the first half of 2027 and has been building its field medical, reimbursement and strategic accounts teams ahead of that potential launch. Intellia is developing nexiguran ziclumeran (nex-z) with Regeneron for transthyretin (ATTR) amyloidosis. Both phase III studies of nex-z, MAGNITUDE in ATTR cardiomyopathy and MAGNITUDE-2 in hereditary ATTR amyloidosis with polyneuropathy, were previously placed on clinical hold by the FDA. Earlier this year, the FDA lifted the clinical holds on both studies, following which enrollment and dosing resumed in both studies in the first quarter of 2026. NTLA remains on track to complete enrollment in MAGNITUDE-2 in the second half of 2026. Management said screening activity is accelerating globally. The MAGNITUDE study has enrolled well over 650 patients. Working with Regeneron and external experts, Intellia analyzed more than 600 patient samples across nex-z clinical studies. The analysis found that the highest observed liver transaminase elevations occurred in patients carrying one specific HLA allele. About 12% of the analyzed samples carried the allele, while most carriers did not experience severe transaminase elevations. Intellia has incorporated HLA typing into both ongoing phase III nex-z studies and is providing the information to investigators and patients during screening or before crossover. Intellia Therapeutics, Inc. price-consensus-eps-surprise-chart | Intellia Therapeutics, Inc. Quote Intellia currently carries a Zacks Rank #4 (Sell). Some better-ranked stocks in the biotech sector are Harmony Biosciences HRMY 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 Harmony Biosciences’ 2026 earnings per share have risen from $3.20 to $3.33, while estimates for 2027 have increased from $3.64 to $3.92 during the same time. HRMY shares have gained 3.5% year to date. Harmony Biosciences’ earnings missed estimates in three of the trailing four quarters and beat on the remaining occasion, delivering an average negative surprise of 13.97%. 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 159.3% 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 Intellia Therapeutics, Inc. (NTLA) : Free Stock Analysis Report Regeneron Pharmaceuticals, Inc. (REGN) : Free Stock Analysis Report Liquidia Corporation (LQDA) : Free Stock Analysis Report Harmony Biosciences Holdings, Inc. (HRMY) : Free Stock Analysis Report This article originally published on Zacks Investment Research (zacks.com). Zacks Investment Research

This article first appeared on GuruFocus. Cash Position: Cash, equivalents, and marketable securities totaled $628.4 million as of June 30, 2026, up from $605.1 million at the end of 2025. Cash Runway: Company expects current cash balance to fund operations at least into 2028, excluding all potential product revenues. Collaboration Revenue: $7.7 million for Q2 2026, down from $14.2 million in the prior-year quarter, primarily due to reduced revenue from Regeneron. R&D Expenses: $82.6 million for Q2 2026, down from $97.0 million in the prior-year quarter, driven by lower external costs and reduced stock-based compensation. G&A Expenses: $37.8 million for Q2 2026, up from $27.2 million in the prior-year quarter, due to commercial infrastructure build-out and higher legal expenses. Net Loss: $106.6 million for Q2 2026, compared to a net loss of $101.3 million in the prior-year quarter. Equity Financing: Completed an equity financing in April 2026, yielding approximately $195 million in net proceeds. Warning! GuruFocus has detected 5 Warning Signs with NTLA. Is NTLA fairly valued? Test your thesis with our free DCF calculator. Release Date: August 06, 2026 For the complete transcript of the earnings call, please refer to the full earnings call transcript. Intellia Therapeutics Inc (NASDAQ:NTLA) reported positive top-line results from the Phase III HALO trial for LONVOSI in hereditary angioedema (HAE), achieving statistical significance on the primary and all key secondary endpoints, including an 87% reduction in mean monthly attacks versus placebo. The company is advancing its rolling BLA submission for LONVOSI with the FDA and expects to announce acceptance by the end of 2026, positioning it for a potential U.S. launch in the first half of 2027 as the world's first in vivo gene editing product. Intellia Therapeutics Inc (NASDAQ:NTLA) resumed enrollment and dosing in both Phase III trials for NEXI in ATTR after resolving clinical holds, with screening rates rapidly increasing globally and over 650 patients enrolled in the Magnitude trial. The company identified a specific HLA allele (C0501) associated with higher-grade transaminase elevations in NEXI trials, enabling the implementation of HLA typing and mitigation strategies to enhance patient safety and informed decision-making. Intellia Therapeutics Inc (NASDAQ:NTLA) maintains a strong financial position with $628.4 million in cash, sufficient to fund operations into 2028, excluding any potential product revenues from a LONVOSI launch. Intellia Therapeutics Inc (NASDAQ:NTLA) faces uncertainty in the ATTR market following the disappointing top-line results from the CardioTransform trial of a competing TTR silencer, which has sparked debate about the efficacy of combination therapies. The company identified a statistically significant finding that patients carrying the C0501 HLA allele have a higher rate of grade 3 or greater transaminase elevations, potentially limiting the addressable patient population for NEXI. Intellia Therapeutics Inc (NASDAQ:NTLA) reported a decrease in collaboration revenue to $7.7 million in Q2 2026 from $14.2 million in the prior year quarter, primarily due to reduced revenue from Regeneron. The company's net loss widened to $106.6 million in Q2 2026 from $101.3 million in the prior year quarter, reflecting increased G&A expenses tied to commercial infrastructure build-out and higher legal costs. Intellia Therapeutics Inc (NASDAQ:NTLA) is still awaiting detailed data from the CardioTransform trial and has not yet guided on data timing for its Magnitude trial, leaving uncertainty around the potential need for trial design changes. Q: Can you discuss the implications of the C0501 HLA allele finding for the 12% of patients who carry it, and is there another parameter that could help fine-tune patient selection? What is the biologic relationship triggering the immune response?A: John Leonard, CEO, explained that the finding confirms the hypothesis of an adaptive immune response, as HLAs are deeply implicated in cell-mediated immunity. This validates the mitigation measures already in place. For patients carrying the C0501 allele, the information is being shared with investigators and patients so they can make informed decisions. While the relationship is statistically significant, many carriers do not experience liver enzyme elevations. The company expects some patients may choose to self-exclude, but for those who see a favorable benefit-risk profile, the therapy remains available. Intellia is engaging with the FDA on the findings and any further implications. Q: Given the disappointing CardioTransform results, what options are you contemplating to potentially optimize the Magnitude trial design to maximize the probability of success?A: John Leonard, CEO, stated that the first priority is understanding the CardioTransform data in detail. Intellia believes the negative outcome is specific to eplontersen and not applicable to combination therapy in general. The key factors to analyze include the degree of TTR reduction, variability, speed of treatment effect, and durability. The company remains open-minded and will consider changes to the trialsuch as enrollment size or follow-up durationonly after a thorough review of the data and consultation with experts. No changes will be made until the full picture is understood. Q: Can you confirm that the HLA allele finding is specific to NEXI and not LONVOSI? And is it correct that only a fraction of the 12% of patients carrying the allele actually experienced elevations?A: John Leonard, CEO, confirmed the finding is almost certainly specific to NEXI, as HLA molecules bind to very specific short peptides that would not be implicated in the LONVOSI treatment effect. This is supported by the New England Journal publication showing no signal in LONVOSI patients. Edward Dulac, CFO, added that while 12% of the 600+ samples carry the allele, only a small subset of those patients experienced higher-grade transaminase elevations, meaning the vast majority of carriers did not have severe elevations. Q: What is the background stabilizer use in the Magnitude trial, and do you expect that to change given the CardioTransform results? Also, do you see enrollment changes due to HLA screening?A: John Leonard, CEO, noted that background stabilizer use is running around 80%, consistent with projections and reflecting real-world usage patterns. Regarding HLA screening, investigators view the finding as confidence-building, as it allows for better patient selection. The company is rapidly rolling out the information to sites and patients. Rather than slowing enrollment, many investigators believe the HLA typing will actually accelerate the pace of screening, which is already increasing globally. Q: Can you provide more detail on the HLA analysis? How many patients with grade 3 liver signals do not carry the allele, and are you considering additional prophylaxis for C0501 carriers?A: John Leonard, CEO, declined to release the full data set at this time, stating it will be presented at an appropriate future date. For C0501-positive patients who choose to participate, no additional prophylaxis is planned, as the current mitigation measures are deemed appropriate for a cell-mediated immune response. The key value of the finding is identifying at-risk patients before an event occurs, allowing them to make informed decisions. For the ~90% of patients who do not carry the allele, the likelihood of a high-grade LFT elevation is extremely low, which is confidence-building. Q: Do you expect the HLA genotyping finding to be on the label if approved, and will every patient be genotyped in a commercial setting?A: John Leonard, CEO, stated it is too early to say whether this will be reflected on the label, as that will depend on the data accumulated and regulatory discussions. In the meantime, the company is excited about the finding's ability to focus benefit-risk on patients who can most benefit. HLA typing is being incorporated into the screening process for the Phase III trials, and it is not expected to slow down screening. In fact, investigators believe it may pick up the pace, as it provides valuable information for patient selection. Q: Regarding the LONVOSI BLA, has the final submission been completed, and are you expecting a bolus of patients at launch if approved?A: John Leonard, CEO, indicated the company is far into the BLA filing process and expects to announce FDA acceptance by the end of the year, which will provide more information on PDUFA dates and priority review. He expressed excitement about the team's preparation and the efficient collaboration with the FDA. While he did not provide specific launch projections, the company's pre-commercial readiness efforts are well underway, including hiring for field medical, reimbursement, and strategic accounts teams. Q: Is the HLA genotyping finding specific to ATTR cardiomyopathy, or does it also apply to polyneuropathy? And are you implementing genotyping in other trials?A: John Leonard, CEO, clarified that the genotyping is being applied across the entire NEXI program, irrespective of the indication. The same rules and information are being provided for both the cardiomyopathy and polyneuropathy studies. For other programs, the company is not currently doing genotyping on a standard basis, as the finding is believed to be very specific to NEXI, and it would be difficult to know what to look for in other programs. Q: Can you elaborate on the patient gateway being built with HAE Reframe, and what can we expect from the upcoming symposium data?A: John Leonard, CEO, explained that the HAE Reframe initiative is designed to elevate understanding of the burdens patients face with lifelong chronic therapy, including prior authorizations and the ongoing impact of the disease. The goal is to ensure payers, patients, and doctors understand the contrast between chronic therapy burdens and the one-time LONVOSI profile. At the upcoming symposium, the company will present molecular-level data on the drug's behavior, including a specific case of a patient who benefited significantly but did not achieve attack-free status, likely due to a second, unrelated process. Q: Regarding the LONVOSI NEJM publication, can you comment on the ALT/AST excursions seen at later time points in some patients?A: John Leonard, CEO, addressed For the complete transcript of the earnings call, please refer to the full earnings call transcript.

Varsetatug masetecan (“Varseta-M”) Program: - Phase 1 monotherapy update in advanced colorectal cancer (CRC) expected by the end of 2026. Registrational study planned for initiation in 1H 2027 - - Phase 1 study in combination with bevacizumab in 3L+ mCRC ongoing. Phase 1/2 chemotherapy combination study focused in 2L mCRC initiating in Q4 2026 - - Phase 1 monotherapy expansion cohorts initiating in Q3 2026 in gastric and gastroesophageal junction (GEJ), EpCAM-selected pancreatic ductal adenocarcinoma (PDAC), and EpCAM-selected biliary tract cancer (BTC) - Corporate: - Regeneron alliance in masked bispecific immunotherapies expanded to additional targets - - Board of directors and executive leadership team strengthened with additions of Charles Fuchs, MD, Mamata Gokhale, Ph.D. and Alejandra Carvajal, JD - - Company to host conference call today at 5 p.m. ET / 2 p.m. PT - SOUTH SAN FRANCISCO, Calif., Aug. 06, 2026 (GLOBE NEWSWIRE) -- CytomX Therapeutics, Inc. (Nasdaq: CTMX), a leader in the field of masked, conditionally activated biologics, today announced Q2 2026 financial results and provided a business update. “CytomX had a productive second quarter as we advanced and broadened the Varseta-M program, the only EpCAM-directed antibody drug conjugate (ADC) in clinical development and a potentially best-in-class ADC for colorectal cancer. As we drive Varseta-M towards its first registrational study in late-line CRC, we are also accelerating our broader vision of earlier line utilization in CRC combination regimens, while also initiating development in additional gastrointestinal cancers of high unmet need,” said Dr. Sean McCarthy, chairman and CEO of CytomX Therapeutics. “Additionally, this quarter, we were excited to announce a significant expansion of our Regeneron collaboration in bispecific immunotherapies, further validating our PROBODY® therapeutic platform expertise. We are also pleased to be strengthening the CytomX team and board of directors for CytomX’s next phase of growth as we remain highly focused on making a meaningful difference for patients and stakeholders over the near- and long-term.” Pipeline Program Updates: Varsetatug masetecan (EpCAM PROBODY Topo-1 ADC, CX-2051) Varseta-M Monotherapy CRC: Varseta-M CRC Combinations: Varseta-M Non-CRC Indication Expansion: CX-801 (PROBODY Interferon alpha-2b) The CX-801 Phase 1 study in advanced melanoma is ongoing. The CX-801 monotherapy dose escalation portion of the study has reached the fourth dose level. CX-801 monotherapy has been generally well tolerated at dose levels exceeding the approved dose of unmasked IFNα2b.2 In May 2025, Phase 1 dose escalation of CX-801 in combination with KEYTRUDA® (pembrolizumab) was initiated. Dose escalation of CX-801 in combination with KEYTRUDA® has cleared the third dose level and enrollment into the study continues. Initial clinical data for CX-801 in combination with KEYTRUDA® in advanced melanoma is expected in the first half of 2027. KEYTRUDA® is a registered trademark of Merck Sharp & Dohme LLC, a subsidiary of Merck & Co., Inc., Rahway, NJ, USA. Corporate and Financial: Strengthened Board of Directors and Leadership for Next Phase of Growth Regeneron Collaboration Expansion: Financial: Q2 2026 Financial Results: Cash, cash equivalents and investments totaled $330.3 million as of June 30, 2026, compared to $346.7 million as of March 31, 2026. Total revenue was $1.4 million for the quarter ended June 30, 2026, compared to $18.7 million for the second quarter of 2025. The decrease in revenue was driven primarily by the completion of the Company’s performance obligation during 2025 in the collaborations with Bristol Myers Squibb and lower research activities in the Astellas collaboration which concluded in the second quarter of 2026. Total operating expense for the quarter ended June 30, 2026 was $25.2 million compared to $19.9 million for the quarter ended June 30, 2025, an increase of $5.3 million. Research and development expenses increased by $4.3 million during the quarter ended June 30, 2026, to $17.6 million compared to $13.3 million for the quarter ended June 30, 2025. Research and development expenses increased primarily due to manufacturing activities for Varseta-M as well as increased personnel related costs and general research and development expenses. General and administrative expenses increased by $1.0 million during the quarter ended June 30, 2026, to $7.6 million, compared to $6.6 million for the quarter ended June 30, 2025. Increased general and administrative expenses were primarily driven by higher consulting expenses and higher rent expenses. About CytomX Therapeutics, Inc.CytomX is a clinical-stage, oncology-focused biopharmaceutical company focused on developing novel conditionally activated, masked PROBODY® therapeutics designed to be localized to the tumor microenvironment. By pioneering a novel pipeline of localized biologics, powered by its PROBODY therapeutic platform, CytomX’s vision is to create safer, more effective therapies for the treatment of cancer. CytomX’s robust and differentiated pipeline comprises therapeutic candidates across multiple treatment modalities including antibody-drug conjugates (“ADCs”), cytokines and T-cell engagers. CytomX’s clinical-stage pipeline includes varsetatug masetecan (Varseta-M; CX-2051) and CX-801. Varseta-M is a masked, conditionally activated ADC armed with a topoisomerase-1 inhibitor payload and directed toward epithelial cell adhesion molecule (EpCAM). EpCAM is a highly expressed tumor antigen that has previously been undruggable due to expression on normal tissues. Varseta-M is designed to open a therapeutic window for this high potential target and is initially being developed for the treatment of metastatic colorectal cancer. Varseta-M was discovered in collaboration with ImmunoGen, now part of AbbVie. CX-801 is a masked interferon alpha-2b PROBODY® cytokine with broad potential applicability in traditionally immuno-oncology sensitive as well as insensitive (cold) tumors. CX-801 is initially being developed for the treatment of metastatic melanoma. CytomX has established strategic collaborations with multiple leaders in oncology, including Amgen, Regeneron and Moderna. For more information about CytomX and how it is working to make conditionally activated treatments the new standard-of-care in the fight against cancer, visit www.cytomx.com and follow us on LinkedIn and X (formerly Twitter). CytomX Therapeutics Forward-Looking StatementsThis press release includes forward-looking statements. Such forward-looking statements involve known and unknown risks, uncertainties and other important factors that are difficult to predict, may be beyond CytomX’s control, and may cause the actual results, performance, or achievements to be materially different from any future results, performance or achievements expressed or implied in such statements, including those related to the future potential of partnerships or collaboration agreements and projected cash runway. Accordingly, you should not rely on any of these forward-looking statements, including those relating to the potential benefits, safety and efficacy or progress of CytomX’s or any of its collaborative partners’ product candidates, including varsetatug masetecan (Varseta-M) and CX-801, the potential benefits or applications of CytomX’s PROBODY® therapeutic platform, CytomX's planned interactions with the U.S. Food and Drug Administration and the ability to align on a potential registrational study design and regulatory pathway for Varseta-M, CytomX’s or its collaborative partners’ ability to develop and advance product candidates into and successfully complete clinical trials, including the ongoing and planned clinical trials of Varseta-M and CX-801 and the timing of initial and ongoing data availability for CytomX’s clinical trials, including Varseta-M and CX-801, and other development milestones. Risks and uncertainties that contribute to the uncertain nature of the forward-looking statements include: the unproven nature of CytomX’s novel PROBODY® therapeutic technology; uncertainties around the Company’s ability to raise sufficient funds to carry out its planned research and development; CytomX’s clinical trial product candidates are in the initial stages of clinical development and its other product candidates are currently in preclinical development, and the process by which preclinical and clinical development could potentially lead to an approved product is long and subject to significant risks and uncertainties, including the possibility that the results of preclinical research and early clinical trials, including initial Varseta-M clinical trial results, may not be predictive of future results; the possibility that CytomX’s clinical trials will not be successful; the possibility that current preclinical research may not result in additional product candidates; the possibility that CytomX may not be able to realize the full potential of its collaborations; CytomX’s dependence on the success of Varseta-M and CX-801; CytomX’s reliance on third parties for the manufacture of the Company’s product candidates; possible regulatory developments in the United States and foreign countries, including China and the European Union; and the risk that CytomX may incur higher costs than expected for research and development. Additional applicable risks and uncertainties include those relating to CytomX’s preclinical research and development, clinical development, and other risks identified under the heading "Risk Factors" included in CytomX’s Quarterly Report on Form 10-Q filed with the SEC on August 6, 2026. The forward-looking statements contained in this press release are based on information currently available to CytomX and speak only as of the date on which they are made. CytomX does not undertake and specifically disclaims any obligation to update any forward-looking statements, whether as a result of any new information, future events, changed circumstances or otherwise. PROBODY is a U.S. registered trademark of CytomX Therapeutics, Inc. All other trademarks are the properties of their respective owners.Company Contact:Chris OgdenSVP, Chief Financial [email protected] Investor Contact:Precision AQ Stephanie [email protected] Media Contact:Precision AQColleen [email protected] __________________(1)    The condensed balance sheet as of December 31, 2025 was derived from the audited financial statements included in the Company's Annual Report on Form 10-K for the year ended December 31, 2025. 1 Dose Optimization utilizes adjusted ideal body weight dosing2 Merck & Co., Inc. (2018). Sylatron (peginterferon alfa-2b) prescribing information. U.S. Food and Drug Administration

Regeneron (REGN) could be a solid addition to your portfolio given a notable revision in the company's earnings estimates. While the stock has been gaining lately, the trend might continue since its earnings outlook is still improving. The upward trend in estimate revisions for this biopharmaceutical company reflects growing optimism of analysts on its earnings prospects, which should get reflected in its stock price. After all, empirical research shows a strong correlation between trends in earnings estimate revisions and near-term stock price movements. This insight is at the core of our stock rating tool -- the Zacks Rank. The five-grade Zacks Rank system, which ranges from a Zacks Rank #1 (Strong Buy) to a Zacks Rank #5 (Strong Sell), has an impressive externally-audited track record of outperformance, with Zacks #1 Ranked stocks generating an average annual return of +25% since 2008. Consensus earnings estimates for the next quarter and full year have moved considerably higher for Regeneron, as there has been strong agreement among the covering analysts in raising estimates. The chart below shows the evolution of forward 12-month Zacks Consensus EPS estimate: The company is expected to earn $14.52 per share for the current quarter, which represents a year-over-year change of +22.7%. Over the last 30 days, the Zacks Consensus Estimate for Regeneron has increased 15.85% because five estimates have moved higher compared to no negative revisions. The company is expected to earn $52.03 per share for the full year, which represents a change of +17.4% from the prior-year number. The revisions trend for the current year also appears quite promising for Regeneron, with eight estimates moving higher over the past month compared to no negative revisions. The consensus estimate has also received a boost over this time frame, increasing 15.07%. The promising estimate revisions have helped Regeneron earn a Zacks Rank #2 (Buy). The Zacks Rank is a tried-and-tested rating tool that helps investors effectively harness the power of earnings estimate revisions and make the right investment decision.You can see the complete list of today's Zacks #1 Rank (Strong Buy) stocks here. Our research shows that stocks with Zacks Rank #1 (Strong Buy) and 2 (Buy) significantly outperform the S&P 500. Regeneron shares have added 12.5% over the past four weeks, suggesting that investors are betting on its impressive estimate revisions. So, you may consider adding it to your portfolio right away to benefit from its earnings growth prospects. 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 Regeneron Pharmaceuticals, Inc. (REGN) : Free Stock Analysis Report This article originally published on Zacks Investment Research (zacks.com). Zacks Investment Research

Ultragenyx Pharmaceutical RARE reported second-quarter 2026 loss of 90 cents per share, which was narrower than the Zacks Consensus Estimate of a loss of $1.27. The company had incurred a loss of $1.17 per share in the year-ago quarter. Total revenues in the second quarter were $214 million, which surged 28.1% year over year due to higher product sales. The top line also beat the Zacks Consensus Estimate of $181 million. Management stated that second-quarter 2026 revenues were the highest quarterly revenues ever reported by the company. Ultragenyx markets four drugs, namely Crysvita, Mepsevii, Dojolvi and Evkeeza. Crysvita is approved for treating X-linked hypophosphatemia, an inherited disorder and tumor-induced osteomalacia, an ultra-rare disease. Mepsevii is approved to treat Mucopolysaccharidosis VII, also known as Sly syndrome. Dojolvi is approved for treating all forms of long-chain fatty acid oxidation disorders. Evkeeza is indicated for homozygous familial hypercholesterolemia (HoFH). In 2022, Ultragenyx announced a license and collaboration agreement with Regeneron Pharmaceuticals REGN for Evkeeza, which is approved in multiple geographies as a first-in-class therapy for use together with diet and other low-density lipoprotein-cholesterol-lowering therapies to treat adults and adolescents aged 12 years and older with HoFH. Per the deal, RARE has obtained the rights to develop, commercialize and distribute Evkeeza outside the United States. The regions include the European Economic Area. The collaboration with Regeneron for Evkeeza gives Ultragenyx a fourth approved product that adds to the top line. However, REGN solely commercializes Evkeeza in the United States. Year to date, shares of Ultragenyx have gained 12.2% compared with the industry’s 1.6% rise. Image Source: Zacks Investment Research Crysvita’s total revenues were $156 million, up 28.9% year over year. Management noted that Crysvita sales were consistent with expected seasonality in the United States and Canada and ordering patterns in Latin America. Crysvita’s net product revenues in the second quarter of 2026 included $94 million from North America, $54 million from Latin America and Turkey, and $8 million from Europe. Mepsevii product revenues increased 11.1% year over year to $10 million in the reported quarter. Dojolvi product revenues were $27 million, up 17.4%, driven by strong demand. Evkeeza recorded sales of $21 million in the second quarter, up 50%, driven by increased demand from new country launches and early access. Operating expenses of $289 million in the quarter rose 5.1% year over year due to increased investments in multiple late-stage pipeline programs and marketing costs for approved drugs. Operating expenses included research and development (R&D) expenses of $167 million (up 1.2%), selling, general and administrative (SG&A) expenses of $88 million (up 1.1%) and cost of sales of $34 million (up 47.8%). Cash, cash equivalents and marketable securities amounted to $436 million as of June 30, 2026, compared with $534 million as of March 31, 2026. Ultragenyx continues to expect total revenues in 2026, excluding potential revenues from new product launches, between $730 million and $760 million. Crysvita revenues in 2026 are expected to be in the range of $500-$520 million, reflecting growing underlying global demand. Meanwhile, Dojolvi revenues are expected to be between $100 million and $110 million in 2026. In April 2026, the FDA accepted the resubmitted biologics license application (BLA) seeking accelerated approval of UX111 for the treatment of MPS IIIA. The application included extensive long-term data with follow-up of up to eight years. The data showed sustained clinical benefits compared with the decline seen in natural history studies, along with durable treatment effects across multiple clinical measures and biomarkers, while maintaining an acceptable safety profile. A final decision from the regulatory body is expected on Sept. 19, 2026. The FDA has also accepted for review Ultragenyx’s BLA for its investigational AAV8 gene therapy, DTX401, to treat glycogen storage disease type Ia. A final decision from the regulatory agency is expected on Aug. 23, 2026. Ultragenyx is also evaluating UX701, an investigational AAV9 gene therapy, in a phase I/II/III Cyprus2+ study to treat Wilson disease and expects to share top-line data in the fourth quarter of 2026. Ultragenyx’s GTX-102, an investigational antisense oligonucleotide, is being developed in the pivotal phase III Aspire study for treating Angelman syndrome (AS) patients with a genetically confirmed diagnosis of UBE3A deletion. Top-line data are expected in September or October 2026. Meanwhile, enrollment in the phase II/III Aurora study is currently ongoing to evaluate the safety and efficacy of GTX-102 for treating other AS genotypes in other patient age groups. This additional study aims to enable treatment for a broader range of AS patients. The study is expected to complete enrollment in the second half of 2026. Ultragenyx Pharmaceutical Inc. price-consensus-eps-surprise-chart | Ultragenyx Pharmaceutical Inc. Quote Ultragenyx currently carries a Zacks Rank #2 (Buy). Some other top-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 8.6% 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 156.3% 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 Ultragenyx Pharmaceutical Inc. (RARE) : Free Stock Analysis Report Regeneron Pharmaceuticals, Inc. (REGN) : 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