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NovartisB
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2026-09-03
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Earnings documents stored for NVS.

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Investor releaseQuarter not tagged2026-09-03

Why Is Merck (MRK) Up 18.2% Since Last Earnings Report?

Zacks
A month has gone by since the last earnings report for Merck (MRK). Shares have added about 18.2% in that time frame, outperforming the S&P 500. But investors have to be wondering, will the recent positive trend continue leading up to its next earnings release, or is Merck due for a pullback? Well, first let's take a quick look at its most recent earnings report in order to get a better handle on the recent catalysts for Merck & Co., Inc. before we dive into how investors and analysts have reacted as of late. Merck reported an adjusted loss of 13 cents per share for the second quarter of 2026, narrower than the Zacks Consensus Estimate of a loss of 26 cents. In the year-ago quarter, the company reported adjusted earnings of $2.13 per share.Including acquisition and divestiture-related costs, restructuring costs, income and losses from investments in equity securities and certain other items, loss was 54 cents per share in the second quarter versus earnings of $1.76 per share in the year-ago quarter.Adjusted as well as reported earnings included a charge of $2.31 per share recorded in the quarter related to the acquisition of Terns Pharmaceuticals, which was completed during the period.Revenues in the second quarter increased 5% year over year on a reported basis and 4% excluding foreign exchange (Fx) to $16.61 billion. Sales beat the Zacks Consensus Estimate of $16.33 billion. Higher sales of oncology drugs, including Keytruda and contributions from new products like Winrevair, Welireg and Capvaxive, and the Animal Health segment were partially offset by lower sales of Gardasil and some other vaccines. The Pharmaceutical segment generated revenues of $14.76 billion, up 5% year over year (4% excluding FX). Pharmaceutical segment revenues beat the Zacks Consensus Estimate of $14.28 billion.All sales growth numbers discussed below exclude FX impact. Combined sales of Keytruda and Keytruda Qlex increased 4% to $8.37 billion. The reported figure topped the Zacks Consensus Estimate of $8.06 billion. Sales of Keytruda benefited from rapid uptake across earlier-stage indications and continued strong momentum in metastatic indications. Keytruda sales in the second quarter included $463 million in sales of Keytruda Qlex, the subcutaneous formulation of Keytruda, compared to $128 million in the previous quarter as patient adoption has increased since the permanent J-co…Read full document

A month has gone by since the last earnings report for Merck (MRK). Shares have added about 18.2% in that time frame, outperforming the S&P 500. But investors have to be wondering, will the recent positive trend continue leading up to its next earnings release, or is Merck due for a pullback? Well, first let's take a quick look at its most recent earnings report in order to get a better handle on the recent catalysts for Merck & Co., Inc. before we dive into how investors and analysts have reacted as of late. Merck reported an adjusted loss of 13 cents per share for the second quarter of 2026, narrower than the Zacks Consensus Estimate of a loss of 26 cents. In the year-ago quarter, the company reported adjusted earnings of $2.13 per share.Including acquisition and divestiture-related costs, restructuring costs, income and losses from investments in equity securities and certain other items, loss was 54 cents per share in the second quarter versus earnings of $1.76 per share in the year-ago quarter.Adjusted as well as reported earnings included a charge of $2.31 per share recorded in the quarter related to the acquisition of Terns Pharmaceuticals, which was completed during the period.Revenues in the second quarter increased 5% year over year on a reported basis and 4% excluding foreign exchange (Fx) to $16.61 billion. Sales beat the Zacks Consensus Estimate of $16.33 billion. Higher sales of oncology drugs, including Keytruda and contributions from new products like Winrevair, Welireg and Capvaxive, and the Animal Health segment were partially offset by lower sales of Gardasil and some other vaccines. The Pharmaceutical segment generated revenues of $14.76 billion, up 5% year over year (4% excluding FX). Pharmaceutical segment revenues beat the Zacks Consensus Estimate of $14.28 billion.All sales growth numbers discussed below exclude FX impact. Combined sales of Keytruda and Keytruda Qlex increased 4% to $8.37 billion. The reported figure topped the Zacks Consensus Estimate of $8.06 billion. Sales of Keytruda benefited from rapid uptake across earlier-stage indications and continued strong momentum in metastatic indications. Keytruda sales in the second quarter included $463 million in sales of Keytruda Qlex, the subcutaneous formulation of Keytruda, compared to $128 million in the previous quarter as patient adoption has increased since the permanent J-code was established in April.Merck is seeing an increase in usage of Keytruda in tumors that primarily affect women, including cervical and breast cancers, as well as Keytruda in combination with Padcev in first-line, locally advanced or metastatic urothelial cancer.Merck said on the conference call that Keytruda’s U.S. growth will moderate as penetration peaks in several indications. The comparison will also be impacted by a $250 million wholesaler purchase benefit in the third quarter of 2025.On the conference call, Merck’s CEO Robert Davis said that the Keytruda exclusivity transition will create a shallow decline followed by a fast return to growth.Alliance revenues from Lynparza declined 2% to $365 million in the quarter. Lenvima alliance revenues increased 6% to $283 million, driven by higher U.S. demand, partly offset by lower net pricing.Welireg sales surged 67% to $271 million, reflecting higher demand in the United States for certain previously treated advanced renal cell carcinoma patients and continued launch uptake across international markets, particularly Japan. Favorable wholesaler purchasing patterns in the United States also aided performance. In vaccines, sales of HPV vaccines — Gardasil and Gardasil 9 — rose 3% to $1.17 billion. Higher demand in the Asia Pacific and Europe, along with favorable tender timing in Europe, supported the franchise. These gains were partly offset by lower demand and unfavorable timing of CDC purchases in the United States. Gardasil/Gardasil 9 sales missed the Zacks Consensus Estimate of $1.18 billion.Combined sales of ProQuad, M-M-R II and Varivax declined 3% to $592 million, mainly due to lower demand in the United States. Sales of the pneumococcal 15-valent conjugate vaccine Vaxneuvance declined 36% to $148 million due to lower demand in the United States and most international markets as well as unfavorable comparison to the prior year quarter, as public-sector activity in the United States increased sales in that period.Capvaxive sales increased 40% to $184 million, driven by increased demand in the United States and continued launch uptake in some international markets. Sales of the new RSV vaccine, Enflonsia, in the United States were $2 million in the second quarter of 2026 compared with $1 million in the first quarter. In the infectious disease portfolio, Bridion sales rose 8% to $497 million due to higher demand and pricing in the United States, partially offset by lower demand in most international markets due to generic competition. Bridion lost patent exclusivity in the United States in July 2026. However, Merck expects that U.S. sales will decline at a slower pace than previously expected due to lower-than-anticipated generic competition.Prevymis sales increased 28% to $295 million, driven by higher demand in the United States and certain European markets.Januvia/Janumet franchise sales fell 31% year over year to $429 million. Sales of the drug declined due to lower demand and net pricing in the United States due to competition, as well as lower demand in China and most other international markets amid ongoing generic competition.Winrevair sales jumped 75% to $588 million, reflecting continued strong demand in the United States and early launch momentum across international markets, particularly Japan and Europe.Ohtuvayre, added from the October 2025 acquisition of Verona Pharma, contributed $204 million in sales in the second quarter compared with $131 million in the previous quarter. Revenues in the second quarter benefitted from continued prescription demand as well as favorable timing of specialty pharmacy purchases. However, third-quarter revenues will be hurt by the unwinding of specialty pharmacy purchases. Merck is investing in salesforce expansion and patient support to drive accelerated growth in 2027.Regarding its newly launched HIV pill, Idvynso, Merck said it is seeing encouraging early progress on access and reimbursement.Merck’s Animal Health segment generated revenues of $1.78 billion, up 8% year over year on a reported basis and 5% excluding FX. This growth was driven by higher demand for livestock as well as companion animal products. Sales from this segment marginally beat the Zacks Consensus Estimate of $1.77 billion.Sales of livestock products rose 6% to $1.04 billion, driven by higher demand for ruminant and poultry products. Sales of companion animal products rose 5% to $734 million, driven by new product launches. Adjusted gross margin was 81.1%, down 110 basis points year over year due to higher inventory write-offs.Adjusted selling, general and administrative expenses rose 10% to $2.89 billion, reflecting higher administrative and promotional spending.Adjusted research and development expenses increased almost 144% to $9.74 billion in the quarter due to a significantly higher charge of $5.7 billion related to the Terns acquisition compared to a $200 million business development charge a year ago.Excluding these business development charges, operating expenses grew 7% in the quarter. Merck raised its sales guidance for 2026 while lowering its adjusted EPS range to include acquisition costs.The company now expects revenues to be in the range of $66.3-$67.3 billion, compared with the previous expectation of $65.8-$67.0 billion. The new range indicates year-over-year growth of 2% to 4%.The company now expects adjusted earnings of $2.66-$2.76 per share, down from its previous guidance of $5.04-$5.16. The revised range includes a one-time charge of $2.43 per share related to the Terns acquisition.The 2026 guidance represents a significant decline from adjusted EPS of $8.98 in 2025 due to higher charges related to business development transactions. In 2025, Merck recorded a one-time charge of 20 cents per share related to business development transactions.The guidance includes a positive impact from Fx of approximately 1% on sales and around 15 cents on EPS.The adjusted gross margin is expected to be around 81%, lower than the prior expectation of approximately 82% due to higher inventory reserves.Adjusted operating expenses are now expected to be in the range of $42.0-$42.7 billion compared with the earlier projection of $36.0 billion to $36.8 billion. The adjusted tax rate guidance was raised to 35-36% compared with the previous guidance of 23.5-24.5%.In 2026, Merck expects to buy back shares worth $3 billion. It turns out, estimates revision have trended downward during the past month. Currently, Merck has a average Growth Score of C, a grade with the same score on the momentum front. Following the exact same course, the stock has a score of C on the value side, putting it in the middle 20% for this investment strategy. Overall, the stock has an aggregate VGM Score of C. If you aren't focused on one strategy, this score is the one you should be interested in. Estimates have been broadly trending downward for the stock, and the magnitude of these revisions indicates a downward shift. Notably, Merck has a Zacks Rank #3 (Hold). We expect an in-line return from the stock in the next few months. Merck is part of the Zacks Large Cap Pharmaceuticals industry. Over the past month, Novartis (NVS), a stock from the same industry, has gained 5.2%. The company reported its results for the quarter ended June 2026 more than a month ago. Novartis reported revenues of $14.41 billion in the last reported quarter, representing a year-over-year change of +2.5%. EPS of $2.41 for the same period compares with $2.42 a year ago. For the current quarter, Novartis is expected to post earnings of $2.24 per share, indicating a change of -0.4% from the year-ago quarter. The Zacks Consensus Estimate has changed -0.7% over the last 30 days. The overall direction and magnitude of estimate revisions translate into a Zacks Rank #3 (Hold) for Novartis. Also, the stock has a VGM Score of D. 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 Merck & Co., Inc. (MRK) : Free Stock Analysis Report Novartis AG (NVS) : Free Stock Analysis Report This article originally published on Zacks Investment Research (zacks.com). Zacks Investment Research

Investor releaseQuarter not tagged2026-09-02

Novartis' Remibrutinib Delivers Positive Results in Late-Stage MS Studies

Zacks
Novartis NVS announced positive top-line results from the late-stage REMODEL-1/-2 studies on remibrutinib in relapsing multiple sclerosis (RMS). Remibrutinib is a highly selective oral Bruton’s tyrosine kinase (BTK) inhibitor that blocks the BTK pathway, reducing the activation of B cells and innate immune cells to modulate immune regulatory networks and associated neuroinflammation. REMODEL-1 and REMODEL-2 are identical multicenter, randomized, double-blind, active comparator-controlled phase III studies evaluating the efficacy and safety of remibrutinib compared to Aubagio (teriflunomide) in adults with RMS. The studies met their primary endpoint, significantly reducing annualized relapse rate (ARR) versus Aubagio in the targeted patient population. Shares of the company gained 6% following the results. Year to date, Novartis shares have gained 17% compared with the industry’s growth of 13%. Image Source: Zacks Investment Research In the REMODEL-1 and REMODEL-2 studies, approximately 2,000 patients worldwide with recent evidence of disease activity and an Expanded Disability Status Scale (EDSS) score of 0.0-5.5 were randomized equally to receive either remibrutinib 100 mg or Aubagio. The studies comprise an initial double-blind Core Part lasting up to 30 months, followed by an open-label extension of up to five years. Remibrutinib demonstrated superiority versus Aubagio in reducing ARR (primary endpoint) and inflammatory brain lesions with a favorable safety profile. The results of the REMODEL studies establish remibrutinib as a BTK inhibitor that achieved significant reductions in ARR across two late-stage studies in RMS adult patients. Remibrutinib also showed clinically meaningful reductions versus Aubagio in key secondary endpoints related to disability progression, with a positive trend in 3-month confirmed disability progression and nominal significance in 6-month confirmed disability progression in a preplanned combined analysis of REMODEL-1/-2 studies. Remibrutinib demonstrated a favorable safety profile with no liver safety signal, consistent with the drug’s safety profile in the chronic spontaneous urticaria (CSU) indication. Novartis plans to present data from the REMODEL-1 and REMODEL-2 studies as a late-breaking presentation at MSToronto2026, followed by an investor call after the congress. The company also intends to pursue regulatory approva…Read full document

Novartis NVS announced positive top-line results from the late-stage REMODEL-1/-2 studies on remibrutinib in relapsing multiple sclerosis (RMS). Remibrutinib is a highly selective oral Bruton’s tyrosine kinase (BTK) inhibitor that blocks the BTK pathway, reducing the activation of B cells and innate immune cells to modulate immune regulatory networks and associated neuroinflammation. REMODEL-1 and REMODEL-2 are identical multicenter, randomized, double-blind, active comparator-controlled phase III studies evaluating the efficacy and safety of remibrutinib compared to Aubagio (teriflunomide) in adults with RMS. The studies met their primary endpoint, significantly reducing annualized relapse rate (ARR) versus Aubagio in the targeted patient population. Shares of the company gained 6% following the results. Year to date, Novartis shares have gained 17% compared with the industry’s growth of 13%. Image Source: Zacks Investment Research In the REMODEL-1 and REMODEL-2 studies, approximately 2,000 patients worldwide with recent evidence of disease activity and an Expanded Disability Status Scale (EDSS) score of 0.0-5.5 were randomized equally to receive either remibrutinib 100 mg or Aubagio. The studies comprise an initial double-blind Core Part lasting up to 30 months, followed by an open-label extension of up to five years. Remibrutinib demonstrated superiority versus Aubagio in reducing ARR (primary endpoint) and inflammatory brain lesions with a favorable safety profile. The results of the REMODEL studies establish remibrutinib as a BTK inhibitor that achieved significant reductions in ARR across two late-stage studies in RMS adult patients. Remibrutinib also showed clinically meaningful reductions versus Aubagio in key secondary endpoints related to disability progression, with a positive trend in 3-month confirmed disability progression and nominal significance in 6-month confirmed disability progression in a preplanned combined analysis of REMODEL-1/-2 studies. Remibrutinib demonstrated a favorable safety profile with no liver safety signal, consistent with the drug’s safety profile in the chronic spontaneous urticaria (CSU) indication. Novartis plans to present data from the REMODEL-1 and REMODEL-2 studies as a late-breaking presentation at MSToronto2026, followed by an investor call after the congress. The company also intends to pursue regulatory approvals for remibrutinib in RMS across global markets. We remind investors that remibrutinib 25 mg was approved as Rhapsido by the FDA in September 2025 and the EMA in April 2026 for the treatment of adults with CSU. Rhapsido generated sales of $101 million in the first half of 2026. The drug continues to see strong early uptake in the United States, aided by expanding payer coverage and a free-drug program that is helping improve patient access. Outside the United States, sales benefited from early-launch momentum in China, while recent launches in Germany, Austria and the UAE, following second-quarter approvals, also contributed to growth in CSU. A potential label expansion into additional indication should boost sales. Remibrutinib is also being investigated in the REMASTER study in secondary progressive multiple sclerosis, as well as other immune-mediated conditions, such as hidradenitis suppurativa and food allergy. Novartis’ broad and strong portfolio already includes RMS drug Kesimpta (ofatumumab). The drug is an anti-CD20 monoclonal antibody that enables the targeted depletion of B-cells, specifically in lymph nodes. Kesimpta is approved in the United States to treat adults with RMS, including clinically isolated syndrome, relapsing-remitting multiple sclerosis and active secondary progressive multiple sclerosis. Novartis delivered a strong second-quarter performance, demonstrating that its portfolio of newer growth products is increasingly capable of offsetting the impact of generic competition, including the loss of U.S. exclusivity for blockbuster heart failure drug Entresto. Strong demand for key growth brands, including Kisqali, Kesimpta, Scemblix, Pluvicto and Leqvio, is boosting the top line. With 2026 marking the largest patent cliff in the company's history, execution remains the key investment theme. Novartis is also strengthening its long-term growth outlook through targeted business development. Separately, per a Wall Street Journal article, NVS recently paused eight clinical studies on experimental CAR-T cell treatment, rap-cel, after three patients died. Novartis currently carries a Zacks Rank #3 (Hold).  A couple of better-ranked stocks in the drug/biotech sector are Repligen RGEN and Anika Therapeutics ANIK, both sporting a Zacks Rank #1 (Strong Buy) at present. 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 those for 2027 EPS have increased from $2.57 to $2.61 during the same period. RGEN’s shares have gained 3.8% 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 Anika Therapeutics’ 2026 EPS have risen from 41 cents to $1.05, while those for 2027 EPS have increased from 46 cents to 95 cents over the same period. ANIK’s shares have surged 119.7% year to date. 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 Novartis AG (NVS) : Free Stock Analysis Report Repligen Corporation (RGEN) : Free Stock Analysis Report Anika Therapeutics Inc. (ANIK) : Free Stock Analysis Report This article originally published on Zacks Investment Research (zacks.com). Zacks Investment Research

Investor releaseQuarter not tagged2026-09-02

Novartis stock rises after MS drug remibrutinib trial results

Quartz
Novartis stock climbed after the Swiss drugmaker announced positive results Tuesday from two late-stage trials of its oral multiple sclerosis drug remibrutinib, raising expectations that the medicine could become a major revenue driver. By Tuesday's European midday session, Novartis shares had gained 4.5%, pushing the stock's gain for the year to 18%, according to the Wall Street Journal. The two Phase III studies, called REMODEL-1 and REMODEL-2, each enrolled approximately 1,000 patients with relapsing multiple sclerosis and compared remibrutinib against teriflunomide, sold by Sanofi under the brand name Aubagio. Both trials met their primary endpoint, reducing the annualized relapse rate, and showed superiority over teriflunomide across all key secondary endpoints, including a reduction in MRI brain lesions, the company said. The drug also produced clinically meaningful results in slowing disability progression. Novartis said remibrutinib showed no liver safety signal across more than 4,500 clinical trial participants in multiple indications, with no cases meeting Hy's Law criteria. Other medicines in the BTK inhibitor category — which stands for Bruton's tyrosine kinase — have run into trouble with regulators because of liver-toxicity findings, according to Reuters. In December, the U.S. Food and Drug Administration declined to approve Sanofi's tolebrutinib after that drug failed to show superiority to Aubagio in preventing relapses. UBS analyst Matt Weston told clients that "remi looks like it is at least a best-in-class oral agent." Weston added that remibrutinib's pairing of robust relapse control with a cleaner liver-safety record made it "a no-brainer" compared with competing drugs. Reuters reported that two patients died during the trials, with investigators determining the deaths were unconnected to the study drug. Analysts said they would be looking for more detailed safety data. The company intends to pursue regulatory approval for remibrutinib in relapsing multiple sclerosis across major markets, with complete trial data to be shared at an upcoming medical conference in Toronto. "Despite advances in treatment, an unmet need remains for oral therapies that can deliver robust relapse prevention, slow disability progression, while maintaining a favorable safety profile," said Shreeram Aradhye, Novartis's chief medical officer, in the company's anno…Read full document

Novartis stock climbed after the Swiss drugmaker announced positive results Tuesday from two late-stage trials of its oral multiple sclerosis drug remibrutinib, raising expectations that the medicine could become a major revenue driver. By Tuesday's European midday session, Novartis shares had gained 4.5%, pushing the stock's gain for the year to 18%, according to the Wall Street Journal. The two Phase III studies, called REMODEL-1 and REMODEL-2, each enrolled approximately 1,000 patients with relapsing multiple sclerosis and compared remibrutinib against teriflunomide, sold by Sanofi under the brand name Aubagio. Both trials met their primary endpoint, reducing the annualized relapse rate, and showed superiority over teriflunomide across all key secondary endpoints, including a reduction in MRI brain lesions, the company said. The drug also produced clinically meaningful results in slowing disability progression. Novartis said remibrutinib showed no liver safety signal across more than 4,500 clinical trial participants in multiple indications, with no cases meeting Hy's Law criteria. Other medicines in the BTK inhibitor category — which stands for Bruton's tyrosine kinase — have run into trouble with regulators because of liver-toxicity findings, according to Reuters. In December, the U.S. Food and Drug Administration declined to approve Sanofi's tolebrutinib after that drug failed to show superiority to Aubagio in preventing relapses. UBS analyst Matt Weston told clients that "remi looks like it is at least a best-in-class oral agent." Weston added that remibrutinib's pairing of robust relapse control with a cleaner liver-safety record made it "a no-brainer" compared with competing drugs. Reuters reported that two patients died during the trials, with investigators determining the deaths were unconnected to the study drug. Analysts said they would be looking for more detailed safety data. The company intends to pursue regulatory approval for remibrutinib in relapsing multiple sclerosis across major markets, with complete trial data to be shared at an upcoming medical conference in Toronto. "Despite advances in treatment, an unmet need remains for oral therapies that can deliver robust relapse prevention, slow disability progression, while maintaining a favorable safety profile," said Shreeram Aradhye, Novartis's chief medical officer, in the company's announcement. Remibrutinib is already approved in the U.S. and the European Union under the brand name Rhapsido for the skin condition chronic spontaneous urticaria. The company has identified remibrutinib as a key pipeline asset as it works to offset revenue lost when blockbuster heart drug Entresto faced generic competition. Multiple sclerosis drug Kesimpta grew 32% to $1.42 billion in the second quarter, underscoring the commercial potential of the MS franchise. Among a trio of high-profile Novartis development programs expected to produce readouts this year, the REMODEL trials represent the first positive outcome. The company is also awaiting results from studies of heart drug pelacarsen and gene therapy del-desiran.

Investor releaseQuarter not tagged2026-08-11

Legend Biotech Gains 6% on Q2 Earnings Beat as Adjusted EPS Doubles Consensus

24/7 Wall St.
LEGN surged 6% as Q2 revenue of $388M beat estimates and adjusted EPS of $0.16 doubled consensus, marking the company's first-ever profitable quarter. CARVYKTI net sales hit $657M, up 50%, with JNJ co-developer Janssen supporting management's target of over $5B in peak annual sales. Alan Bash, interim CEO following Ying Huang's departure, emphasized continuity as Wall Street's $52 consensus target sits well above current share prices. Act now: the analyst who called NVIDIA in 2010 just named his top 10 AI stocks — and Legend Biotech didn't make the cut. Grab the names FREE today. Shares of Legend Biotech (NASDAQ:LEGN) are climbing 6% to $21.88 Tuesday midday after the company reported Q2 2026 results that paired a solid revenue beat with the first quarter of company-wide profitability in its history. LEGN stock is still down 41% over the past year, so today's reaction reads as validation of Legend Biotech's CARVYKTI ramp. Legend Biotech disclosed the results in an SEC filing before the open and hosted its earnings call at 8:00 a.m. ET. The commercial trajectory of CARVYKTI, the CAR-T multiple myeloma therapy Legend co-develops with Johnson & Johnson (NYSE:JNJ) through its Janssen unit, continues to anchor the investment case here. The setup entering the report was heavy for Legend Biotech. LEGN stock had drifted lower through July, and short-dated positioning had grown cautious around the ongoing CEO transition, leaving room for a squeeze on any clean numbers. Legend Biotech posted total revenue of $387.5 million, up 52% year over year, topping the $362.81 million estimate. Legend Biotech's adjusted EPS came in at $0.16, more than double the roughly $0.07 analyst consensus. The revenue beat headlined the report, though the bigger surprise sat further down the income statement. Act now: the analyst who called NVIDIA in 2010 just named his top 10 AI stocks — and Legend Biotech didn't make the cut. Grab the names FREE today. Legend Biotech booked net income of $33.2 million versus a net loss of $125.4 million a year earlier, adjusted net income of $63.1 million, and operating income of $57.7 million. That marks the company's first quarter of company-wide profitability on both an IFRS and adjusted basis. A meaningful piece of the swing reflects foreign exchange dynamics for Legend Biotech. Unrealized FX losses fell to $0.6 million in Q2 2026 from $110.9 million…Read full document

LEGN surged 6% as Q2 revenue of $388M beat estimates and adjusted EPS of $0.16 doubled consensus, marking the company's first-ever profitable quarter. CARVYKTI net sales hit $657M, up 50%, with JNJ co-developer Janssen supporting management's target of over $5B in peak annual sales. Alan Bash, interim CEO following Ying Huang's departure, emphasized continuity as Wall Street's $52 consensus target sits well above current share prices. Act now: the analyst who called NVIDIA in 2010 just named his top 10 AI stocks — and Legend Biotech didn't make the cut. Grab the names FREE today. Shares of Legend Biotech (NASDAQ:LEGN) are climbing 6% to $21.88 Tuesday midday after the company reported Q2 2026 results that paired a solid revenue beat with the first quarter of company-wide profitability in its history. LEGN stock is still down 41% over the past year, so today's reaction reads as validation of Legend Biotech's CARVYKTI ramp. Legend Biotech disclosed the results in an SEC filing before the open and hosted its earnings call at 8:00 a.m. ET. The commercial trajectory of CARVYKTI, the CAR-T multiple myeloma therapy Legend co-develops with Johnson & Johnson (NYSE:JNJ) through its Janssen unit, continues to anchor the investment case here. The setup entering the report was heavy for Legend Biotech. LEGN stock had drifted lower through July, and short-dated positioning had grown cautious around the ongoing CEO transition, leaving room for a squeeze on any clean numbers. Legend Biotech posted total revenue of $387.5 million, up 52% year over year, topping the $362.81 million estimate. Legend Biotech's adjusted EPS came in at $0.16, more than double the roughly $0.07 analyst consensus. The revenue beat headlined the report, though the bigger surprise sat further down the income statement. Act now: the analyst who called NVIDIA in 2010 just named his top 10 AI stocks — and Legend Biotech didn't make the cut. Grab the names FREE today. Legend Biotech booked net income of $33.2 million versus a net loss of $125.4 million a year earlier, adjusted net income of $63.1 million, and operating income of $57.7 million. That marks the company's first quarter of company-wide profitability on both an IFRS and adjusted basis. A meaningful piece of the swing reflects foreign exchange dynamics for Legend Biotech. Unrealized FX losses fell to $0.6 million in Q2 2026 from $110.9 million a year earlier, cushioning the bottom line even as operating gains did most of the work. The balance sheet also strengthened. Legend Biotech ended the quarter with approximately $965 million in cash, cash equivalents and time deposits and no long-term debt, boosted by about $212 million of net proceeds from a June public offering. Legend Biotech's CARVYKTI net trade sales reached $657 million, up 50% year over year, with U.S. sales up 32% and ex-U.S. sales up 128%. The mix highlights international momentum outpacing the more mature U.S. launch. CARVYKTI is now available across 348 treatment sites and 19 markets, with Ireland the most recent launch for Legend Biotech. Management reiterated peak annual sales potential above $5 billion, keeping CARVYKTI the central pillar of the LEGN investment case. In the multiple myeloma CAR-T space, Bristol Myers Squibb (NYSE:BMY) markets Abecma, the other approved BCMA CAR-T therapy. Competitive positioning against Bristol Myers Squibb remains a key debate, since Legend Biotech is still a single-product commercial story tied largely to CARVYKTI. Legend Biotech reported first clinical proof-of-concept for LB2501, an investigational in vivo CD19/CD20 dual-targeting CAR-T therapy, showing a 100% overall response rate and 83.3% complete response rate at the higher dose level in relapsed or refractory B-cell non-Hodgkin lymphoma. A U.S. IND filing is planned by year-end. The LB2102 DLL3-targeted CAR-T program is licensed to Novartis (NYSE:NVS), giving Legend Biotech a partnered second shot on goal beyond the Johnson & Johnson collaboration. Novartis funding for LB2102 lets Legend Biotech concentrate spend on wholly-owned candidates like LB2501. Sector conditions remain supportive. The iShares Biotechnology ETF (NASDAQ:IBB) is up 18.5% year to date, keeping the backdrop friendly for biotech beats. The IBB ETF is a large-cap-concentrated biotechnology fund and unleveraged, so sector-concentration caution applies here. The leadership context matters with Legend Biotech. Alan Bash is the company's interim CEO following the departure of former CEO Ying Huang last month, and some analysts trimmed their Legend Biotech stock price targets around the transition even while maintaining confidence in CARVYKTI's growth curve. Bash stated in the release, "With meaningful commercial and clinical momentum and a strengthened balance sheet, we remain confident in our ability to advance innovation and progress toward company-wide profitability." The tone from Legend Biotech's management underscored a focus on continuity through the search for a permanent chief executive. Meanwhile, the Wall Street setup still leans constructive. The consensus analyst target on LEGN stock sits at $52.10, well above where shares trade today, with 5 strong buys, 6 buys, and 4 holds. That distribution can compress if analysts lower their ratings and/or price targets around Legend Biotech's CEO search. Traders can watch for whether LEGN stock holds today's gains into the close, and they can check for refreshed analyst notes on Wednesday as well as follow-up commentary from Johnson & Johnson on CARVYKTI's trajectory. This marks a first quarter of profitability, so investors may want to size their positions with Legend Biotech's single-product concentration and early-stage pipeline profile in mind. Act now: the analyst who called NVIDIA in 2010 just named his top 10 AI stocks — and Legend Biotech didn't make the cut. Grab the names FREE today. Contact [email protected] for any questions or corrections.

Investor releaseQuarter not tagged2026-08-06

Monte Rosa Therapeutics Announces Second Quarter 2026 Financial Results and Business Updates

GlobeNewswire
Completed enrollment and dosing for GFORCE-1 study of MRT-8102 in subjects with elevated cardiovascular disease (CVD) risk; readout anticipated in H2 2026 Company expects to initiate multiple MRT-8102 Phase 2 studies, including in patients with elevated atherosclerotic risk and cardiometabolic syndrome in H2 2026, in patients with gout flares in Q4 2026/Q1 2027, and in patients with moderate to severe hidradenitis suppurativa in H1 2027 MODeFIRe-1 Phase 2 study of MRT-2359 activated, in combination with apalutamide in metastatic castration-resistant prostate cancer patients (mCRPC) with androgen receptor (AR) mutations Phase 2a/b clinical trial for VAV1-directed MGD MRT-6160 (DDY391) activated in participants with Sjögren’s disease; study to be conducted by Novartis under global exclusive development and commercialization license agreement Strong balance sheet with cash, cash equivalents, restricted cash, and marketable securities of$626.0 million, expected to support operations into 2029 BOSTON, Aug. 06, 2026 (GLOBE NEWSWIRE) --  Monte Rosa Therapeutics, Inc. (Nasdaq: GLUE), a clinical-stage biotechnology company developing novel molecular glue degrader (MGD)-based medicines, today reported business highlights and financial results for the second quarter ended June 30, 2026. “We’re tremendously proud of our progress to date in 2026, defined by strong execution across our clinical-stage portfolio, with two Phase 2 trials activated and additional trials expected across our programs,” said Markus Warmuth, M.D., Chief Executive Officer of Monte Rosa Therapeutics. “Importantly, for our VAV1 program, Novartis recently activated a Phase 2 study evaluating MRT-6160 (DDY391) in individuals with Sjögren’s disease, representing an important step forward for this program and established collaboration. We look forward to additional Phase 2 study activations expected as part of a broader development effort to evaluate the potential of MRT-6160 across other immune-mediated diseases. In addition, the Phase 2 study of MRT-2359 in combination with apalutamide in mCRPC patients with AR mutations is now activated, and we expect to enroll our first patients imminently, positioning us to validate the strong signals of clinical activity we observed in this patient population in our Phase 1/2 trial. We will update data from the initial Phase 1/2 arm exploring MRT-2359 in advanced…Read full document

Completed enrollment and dosing for GFORCE-1 study of MRT-8102 in subjects with elevated cardiovascular disease (CVD) risk; readout anticipated in H2 2026 Company expects to initiate multiple MRT-8102 Phase 2 studies, including in patients with elevated atherosclerotic risk and cardiometabolic syndrome in H2 2026, in patients with gout flares in Q4 2026/Q1 2027, and in patients with moderate to severe hidradenitis suppurativa in H1 2027 MODeFIRe-1 Phase 2 study of MRT-2359 activated, in combination with apalutamide in metastatic castration-resistant prostate cancer patients (mCRPC) with androgen receptor (AR) mutations Phase 2a/b clinical trial for VAV1-directed MGD MRT-6160 (DDY391) activated in participants with Sjögren’s disease; study to be conducted by Novartis under global exclusive development and commercialization license agreement Strong balance sheet with cash, cash equivalents, restricted cash, and marketable securities of$626.0 million, expected to support operations into 2029 BOSTON, Aug. 06, 2026 (GLOBE NEWSWIRE) --  Monte Rosa Therapeutics, Inc. (Nasdaq: GLUE), a clinical-stage biotechnology company developing novel molecular glue degrader (MGD)-based medicines, today reported business highlights and financial results for the second quarter ended June 30, 2026. “We’re tremendously proud of our progress to date in 2026, defined by strong execution across our clinical-stage portfolio, with two Phase 2 trials activated and additional trials expected across our programs,” said Markus Warmuth, M.D., Chief Executive Officer of Monte Rosa Therapeutics. “Importantly, for our VAV1 program, Novartis recently activated a Phase 2 study evaluating MRT-6160 (DDY391) in individuals with Sjögren’s disease, representing an important step forward for this program and established collaboration. We look forward to additional Phase 2 study activations expected as part of a broader development effort to evaluate the potential of MRT-6160 across other immune-mediated diseases. In addition, the Phase 2 study of MRT-2359 in combination with apalutamide in mCRPC patients with AR mutations is now activated, and we expect to enroll our first patients imminently, positioning us to validate the strong signals of clinical activity we observed in this patient population in our Phase 1/2 trial. We will update data from the initial Phase 1/2 arm exploring MRT-2359 in advanced CRPC by the end of the year.” Dr. Warmuth continued: “Moving forward, we expect a catalyst-rich second half of 2026, including data from our GFORCE-1 study of MRT-8102 in subjects with elevated cardiovascular disease risk, the study having been fully enrolled in June. With these data, we look forward to deepening our understanding of MRT-8102’s clinical activity across multiple dose levels and its impact on inflammatory and cardiometabolic biomarker endpoints. In particular, we will present data on levels of damage-associated molecular patterns (DAMPs) such as calprotectin that promote local inflammation, atherosclerotic plaque instability, and rupture of plaques in individuals with ASCVD – processes not adequately addressed by IL-1/IL-6 antibodies – as well as pathologic cytokines and C-reactive protein (CRP), a well-established pharmacodynamic marker. Over the next 9 to 12 months, we expect to initiate three MRT-8102 Phase 2 studies, including our Phase 2b study, GFORCE-2, later this year, which will inform the potential of MRT-8102 to modulate key parameters of metabolic and atherosclerotic risk, liver inflammation and anemia of inflammation through both primary and secondary study endpoints, as well as GEMINI-1, our study to explore the potential of MRT-8102 to prevent recurrent gout flares following management of acute flares. In summary, we continue to be impressed by the potential of MRT-8102 to address sterile inflammation in a variety of disorders with high unmet medical need, and we continue to explore multiple promising development opportunities in that space.” RECENT HIGHLIGHTS MRT-8102, NEK7-directed MGD for inflammatory diseases driven by the NLRP3 inflammasome and IL-1 Enrollment and dosing have been completed for all subjects participating in the GFORCE-1 Phase 1 study of MRT-8102 in individuals with elevated cardiovascular disease (CVD) risk (NCT07119125). The GFORCE-1 study explored multiple dose levels in a 4-week treatment regimen and 4 weeks of safety follow-up to accelerate dose selection and development in multiple indications, including in atherosclerotic cardiovascular disease (ASCVD), gout, and hidradenitis suppurativa, with an anticipated readout in H2 2026. Based on data reported in January, in subjects with elevated CVD risk, MRT-8102 demonstrated rapid and durable reductions in systemic inflammation, including an 85% median reduction of CRP levels after four weeks of treatment. Additional biomarker data, including impact on calprotectin, an independent risk factor for ASCVD, will be reported. Monte Rosa expects to initiate multiple Phase 2 studies of MRT-8102 in indications with high unmet need and strong biologic rationale for targeting the NLRP3/IL-1 pathway: MRT-6160, VAV1-directed MGD for immune-mediated conditions Monte Rosa’s collaborator Novartis has activated a Phase 2 clinical study for the VAV1-directed MGD MRT-6160 (DDY391) in people living with Sjögren’s disease. Monte Rosa expects to receive a milestone payment upon the first patient visit in the Phase 2 clinical study. More information about the study, “A Phase 2a/​b Study to Assess the Efficacy, Safety and Tolerability of DDY391 in Participants With Sjögren's Disease,” can be found at ClinicalTrials.gov, study identifier NCT07737743. Monte Rosa expects additional Phase 2 study activations as part of a broader development effort to evaluate the potential of MRT-6160 (DDY391) across immune-mediated diseases; Monte Rosa is eligible for additional Phase 2 milestones in conjunction with these study initiations. Monte Rosa has a global exclusive development and commercialization license agreement with Novartis to advance VAV1-directed MGDs, including MRT-6160 (DDY391). Monte Rosa is eligible to receive up to $2.1 billion in development, regulatory, and sales milestones, beginning upon initiation of Phase 2 studies. Novartis is responsible for conducting and funding Phase 2 studies. Monte Rosa will co-fund any Phase 3 clinical development and will share 30% of any profits and losses associated with the manufacturing and commercialization of MRT-6160 in the U.S., and is also eligible for tiered royalties on ex-U.S. net sales. MRT-2359, GSPT1-directed MGD for metastatic CRPC Monte Rosa has activated the MODeFIRe-1 Phase 2 study of MRT-2359. The study will include up to 25 patients to efficiently assess the efficacy of MRT-2359 in combination with the second-generation AR inhibitor apalutamide in mCRPC patients with AR mutations, with potential to expand the study into additional patient subsets. Monte Rosa has a clinical supply agreement with Johnson & Johnson to support the Phase 2 trial evaluating MRT-2359 in combination with apalutamide. More information about the study, “MODeFIRe-1 (Molecular Degrader for Inhibitor Resistance): A Phase 2, Open-Label, Multicenter Study of Oral MRT-2359 in Combination with Apalutamide in Patients with Castration-Resistant Prostate Cancer,” can be found at ClinicalTrials.gov, study identifier: NCT07745361. Enrollment in the initial Phase 1/2 study expansion arm, in patients with advanced CRPC, has been completed. A total of 6 patients with AR mutation were enrolled and treated with MRT-2359 in combination with enzalutamide. Monte Rosa plans to provide an update on this patient subset by the end of the year. Interim data were presented at the ASCO Genitourinary Cancers Symposium (ASCO GU) in February. Cyclin E1 and CDK2-directed MGD programs for solid tumors Monte Rosa expects to submit an IND application for its cyclin E1 (CCNE1)-directed molecular glue degrader program in 2027. Monte Rosa continues to advance its CDK2-directed MGD program for the treatment of ER+ breast cancer toward clinical development. ANTICIPATED UPCOMING MILESTONES AND DEVELOPMENT PRIORITIESImmunology and inflammation programs Readout of MRT-8102 GFORCE-1 study in subjects with elevated CVD risk anticipated in H2 2026. Initiate multiple Phase 2 studies of MRT-8102, including in elevated atherosclerotic risk patients in H2 2026, in gout flare patients in Q4 2026/Q1 2027, and in hidradenitis suppurativa patients in H1 2027. Submit an IND application for a second-generation NEK7-directed MGD in H2 2026. Monte Rosa expects its collaborator, Novartis, to initiate multiple Phase 2 studies of the VAV1-directed MGD MRT-6160 (DDY391) in immune-mediated diseases in 2026. Oncology programs Update on the initial Phase 1/2 expansion arm exploring MRT-2359 in combination with enzalutamide in advanced CRPC by the end of the year. Dose the first patient in the MODeFIRe-1 Phase 2 study of MRT-2359 in combination with apalutamide in mCRPC in Q3 2026. Submit an IND application for a cyclin E1-directed MGD in 2027. SECOND QUARTER 2026 FINANCIAL RESULTS Collaboration Revenue: Collaboration revenue for the second quarter of 2026 was $9.0 million, compared to $23.2 million for the second quarter of 2025. Collaboration revenue represents amounts earned from Monte Rosa’s collaboration and license agreements with Roche and Novartis. Research and Development (R&D) Expenses: R&D expenses for the second quarter of 2026 were $48.0 million, compared to $30.7 million for the second quarter of 2025. The increase was primarily driven by increased spending on the MRT-8102 program and on other development and discovery programs. R&D expenses included non-cash stock-based compensation of $3.3 million for the second quarter of 2026, compared to $2.9 million in the same period in 2025. General and Administrative (G&A) Expenses: G&A expenses for the second quarter of 2026 were $10.1 million compared to $8.1 million for the second quarter of 2025. G&A expenses included non-cash stock-based compensation of $2.7 million for the second quarter of 2026, compared to $2.0 million in the same period in 2025. Net Loss: Net loss for the second quarter of 2026 was $43.4 million, compared to $12.3 million for the second quarter of 2025. Cash Position and Financial Guidance: Cash, cash equivalents, restricted cash, and marketable securities as of June 30, 2026, were $626.0 million, compared to cash, cash equivalents, restricted cash, and marketable securities of $671.2 million as of March 31, 2026. The decrease of $45.2 million was primarily due to operational use of cash. Monte Rosa expects that its cash, cash equivalents, restricted cash, and marketable securities will support operations into 2029. About Monte RosaMonte Rosa Therapeutics is a clinical-stage biotechnology company developing highly selective molecular glue degrader (MGD) medicines for patients living with serious diseases. MGDs are small molecule protein degraders that have the potential to treat many diseases that other modalities, including other degraders, cannot. Monte Rosa’s QuEEN™ (Quantitative and Engineered Elimination of Neosubstrates) discovery engine combines AI-guided chemistry, diverse chemical libraries, structural biology, and proteomics to rationally design MGDs with unprecedented selectivity. Monte Rosa has developed the industry’s leading pipeline of first-in-class and only-in-class MGDs, spanning autoimmune and inflammatory diseases, oncology, and beyond, with three programs in the clinic. Monte Rosa has ongoing collaborations with leading pharmaceutical companies in the areas of immunology, oncology, and neurology. For more information, visit www.monterosatx.com. Forward-Looking Statements This communication includes express and implied “forward-looking statements,” including forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Forward-looking statements include all statements that are not historical facts and in some cases, can be identified by terms such as “may,” “might,” “will,” “could,” “would,” “should,” “expect,” “intend,” “plan,” “objective,” “anticipate,” “believe,” “estimate,” “predict,” “potential,” “continue,” “ongoing,” or the negative of these terms, or other comparable terminology intended to identify statements about the future. Forward-looking statements contained herein include, but are not limited to, statements about our ability to grow our product pipeline, our ability to successfully complete research and further development and commercialization of our drug candidates in current or future indications, including the timing and results of our clinical trials and our ability to conduct and complete clinical trials, statements regarding our progress and speed of development of only-in-class and first-in-class molecular glue degrader therapeutics, statements about our QuEEN™ discovery engine and the broad potential applications of the platform and our ability to create long-term value through focused pipeline execution and strategic collaborations, as well as to expand the targetable protein space for MGD drug discovery, statements about our potential to rationally design MGDs with unprecedented selectivity, statements about the advancement and timeline of our preclinical and clinical programs, pipeline and the various products therein, including (i) the ongoing development of our VAV1-directed degrader, referred to as MRT-6160 (DDY391), including the activation of a Phase 2 clinical study in Sjögren's disease by our collaborator Novartis, our expectations regarding the milestone payments upon Phase 2 study initiations, additional Phase 2 study activations to evaluate the potential of MRT-6160 (DDY391) across immune-mediated diseases, our eligibility to receive up to $2.1 billion in development, regulatory, and sales milestones, Novartis's responsibility for conducting and funding Phase 2 studies, our co-funding of any Phase 3 clinical development and sharing of 30% of any profits and losses associated with the manufacturing and commercialization of MRT-6160 in the U.S., and our eligibility for tiered royalties on ex-U.S. net sales, (ii) the ongoing development of our NEK7-directed MGD, referred to as MRT-8102, including the completion of enrollment and dosing for the GFORCE-1 Phase 1 study in individuals with elevated cardiovascular disease risk, anticipated readout of GFORCE-1 data in H2 2026 and our expectations to initiate multiple Phase 2 studies of MRT-8102, including the GFORCE-2 study in elevated atherosclerotic risk patients in H2 2026, the GEMINI-1 study in gout flare patients in Q4 2026/Q1 2027, and the GALAXY-1 study in hidradenitis suppurativa patients in H1 2027, (iii) the ongoing development of a second-generation NEK7-directed MGD with enhanced CNS penetration and expected IND submission in H2 2026, (iv) our ongoing clinical development of MRT-2359, including the activation of the MODeFIRe-1 Phase 2 study of MRT-2359 in combination with apalutamide in mCRPC, with potential to expand the study into additional patient subsets, and our clinical supply agreement with Johnson & Johnson to support such trial, and (v) progress of our CDK2 and cyclin E1-directed MGD programs, including the timing of an IND application submission in 2027 for a cyclin E1-directed MGD, as well as statements related to the expected potential clinical benefit of any of our candidates, advancement and application of our platform, our ability to capitalize on and potential benefits resulting from our research and translational insights, including announcements related to preclinical programs, as well as our ability to optimize collaborations with industry partners, statements about obligations under our collaboration agreements, expectations around the receipt of payments under such agreements and the future development and commercialization of various products, statements regarding regulatory filings, including the planned timing of such filings, and potential review by regulatory authorities, our use of capital, expenses and other financial results in the future, ability to fund operations and capital expenditures into 2029, as well as our expectations of success for our programs, strength of collaboration relationships and the strength of our financial position, among others. By their nature, these statements are subject to numerous risks and uncertainties, including those risks and uncertainties set forth in our most recent Annual Report on Form 10-K for the year ended December 31, 2025, filed with the U.S. Securities and Exchange Commission on March 17, 2026, and any subsequent filings, that could cause actual results, performance or achievement to differ materially and adversely from those anticipated or implied in the statements. You should not rely upon forward-looking statements as predictions of future events. Although our management believes that the expectations reflected in our statements are reasonable, we cannot guarantee that the future results, performance, or events and circumstances described in the forward-looking statements will be achieved or occur. Recipients are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date such statements are made and should not be construed as statements of fact. We undertake no obligation to publicly update any forward-looking statements, whether as a result of new information, any future presentations, or otherwise, except as required by applicable law. Certain information contained in these materials and any statements made orally during any presentation of these materials that relate to the materials or are based on studies, publications, surveys and other data obtained from third-party sources and our own internal estimates and research. While we believe these third-party studies, publications, surveys and other data to be reliable as of the date of these materials, we have not independently verified, and make no representations as to the adequacy, fairness, accuracy or completeness of, any information obtained from third-party sources. In addition, no independent source has evaluated the reasonableness or accuracy of our internal estimates or research and no reliance should be made on any information or statements made in these materials relating to or based on such internal estimates and research. InvestorsAndrew [email protected] MediaCory Tromblee, Scient [email protected]

Investor releaseQuarter not tagged2026-08-05

Arrowhead Pharmaceuticals Inc (ARWR) (Q3 2026) Earnings Call Highlights: Strong Phase III Data ...

GuruFocus.com
This article first appeared on GuruFocus. Net Loss: $194.3 million, or a loss of $1.36 per share, for the fiscal 2026 third quarter ended June 30, 2026. Revenue: Approximately $75 million for the quarter, up from $28 million in the prior year quarter. Commercial Revenue: Approximately $2.4 million from Redemplo sales, more than double the approximately $1 million recorded in fiscal quarter two. Collaboration Revenue: Approximately $26 million from Sarepta, $20 million from Novartis, $25 million from Madrigal, and $1.2 million from Sanofi. Total Operating Expenses: Approximately $245 million, compared to $193 million in the prior year quarter. R&D Expense: Approximately $198 million, up $36 million year-over-year. SG&A Expense: Approximately $47 million, up $16 million year-over-year. Cash and Investments: Approximately $1.6 billion as of June 30, 2026. Common Shares Outstanding: 141.1 million at quarter end. Priority Review Voucher: $215 million payment expected in fiscal fourth quarter following HSR clearance. Warning! GuruFocus has detected 7 Warning Signs with ARWR. Is ARWR fairly valued? Test your thesis with our free DCF calculator. Release Date: August 04, 2026 For the complete transcript of the earnings call, please refer to the full earnings call transcript. Positive top-line Phase III results from SHASTA-3 and SHASTA-4 studies, with both meeting primary and all pre-specified secondary endpoints, showing median triglyceride reductions of 79% and 81%. Significant reduction in acute pancreatitis events, with a 78% reduction in the broad SHTG population and a 100% reduction in the highest-risk subgroup. Favorable safety and tolerability profile with no new safety signals, no clinically meaningful liver enzyme changes, no hypersensitivity, and no thrombocytopenia signal. Strong commercial momentum in the FCS launch, with prescriptions more than doubling quarter-over-quarter and over 400 unique prescribers. Expansion of regulatory approvals for Redemplo to five geographies, including the EU, Australia, Canada, China, and the U.S., with a unique label covering clinically diagnosed FCS patients in Europe. Acquisition of a priority review voucher to potentially accelerate FDA review of the SNDA for SHTG, potentially bringing the drug to market four months earlier. Robust pipeline progress, including positive interim data for ARO-INHBE in obesity/MASH, full e…Read full document

This article first appeared on GuruFocus. Net Loss: $194.3 million, or a loss of $1.36 per share, for the fiscal 2026 third quarter ended June 30, 2026. Revenue: Approximately $75 million for the quarter, up from $28 million in the prior year quarter. Commercial Revenue: Approximately $2.4 million from Redemplo sales, more than double the approximately $1 million recorded in fiscal quarter two. Collaboration Revenue: Approximately $26 million from Sarepta, $20 million from Novartis, $25 million from Madrigal, and $1.2 million from Sanofi. Total Operating Expenses: Approximately $245 million, compared to $193 million in the prior year quarter. R&D Expense: Approximately $198 million, up $36 million year-over-year. SG&A Expense: Approximately $47 million, up $16 million year-over-year. Cash and Investments: Approximately $1.6 billion as of June 30, 2026. Common Shares Outstanding: 141.1 million at quarter end. Priority Review Voucher: $215 million payment expected in fiscal fourth quarter following HSR clearance. Warning! GuruFocus has detected 7 Warning Signs with ARWR. Is ARWR fairly valued? Test your thesis with our free DCF calculator. Release Date: August 04, 2026 For the complete transcript of the earnings call, please refer to the full earnings call transcript. Positive top-line Phase III results from SHASTA-3 and SHASTA-4 studies, with both meeting primary and all pre-specified secondary endpoints, showing median triglyceride reductions of 79% and 81%. Significant reduction in acute pancreatitis events, with a 78% reduction in the broad SHTG population and a 100% reduction in the highest-risk subgroup. Favorable safety and tolerability profile with no new safety signals, no clinically meaningful liver enzyme changes, no hypersensitivity, and no thrombocytopenia signal. Strong commercial momentum in the FCS launch, with prescriptions more than doubling quarter-over-quarter and over 400 unique prescribers. Expansion of regulatory approvals for Redemplo to five geographies, including the EU, Australia, Canada, China, and the U.S., with a unique label covering clinically diagnosed FCS patients in Europe. Acquisition of a priority review voucher to potentially accelerate FDA review of the SNDA for SHTG, potentially bringing the drug to market four months earlier. Robust pipeline progress, including positive interim data for ARO-INHBE in obesity/MASH, full enrollment of the Phase III Yosemite study for zodasiran, and upcoming data readouts for ARO-DiRPA and ARO-MAP-T. Strong balance sheet with approximately $1.6 billion in cash and investments, providing financial flexibility for ongoing development and commercialization. Partnership strategy yielding significant milestones, including a $25 million upfront payment from Madrigal for ARO-PNPLA-3, with potential for up to $975 million in milestones and royalties. Scalable commercial infrastructure designed to support future indications and multiple products, with plans to expand field force to address over 20,000 HCP targets for SHTG. Net loss widened to $194.3 million in the quarter, compared to $175.2 million in the prior year, driven by higher R&D and SG&A expenses. R&D expenses increased by $36 million year-over-year, reflecting continued high investment in clinical development and manufacturing. SG&A expenses rose to $47 million, up from $31 million, due to increased commercial headcount and launch support costs. The acquisition of the priority review voucher for $215 million represents a significant cash outlay, with the return dependent on successful approval and launch. Commercial revenue from Redemplo remains modest at approximately $2.4 million for the quarter, indicating early-stage launch revenue generation. The SHTG market launch is expected to be a slow ramp due to the need for extensive physician and patient education, potentially limiting near-term revenue growth. Uncertainty regarding ex-U.S. market revenue due to factors like MFN and varying reimbursement processes, which could impact international sales. The company is under embargo for detailed SHASTA-3/4 data until ESC, limiting transparency and potentially affecting investor confidence. The Phase III Yosemite study for zodasiran is not expected to complete until mid-2027, with data in the second half of 2027, delaying potential revenue from this program. The company faces competitive pressure in the SHTG market, with a competitor already launched, and the need to justify a premium price for Redemplo. Q: With the SHASTA-3 and SHASTA-4 data in hand, what are the gating factors for the sNDA submission by year-end 2026, and can you comment on any imbalances in liver fat, ALP elevations, or glycemic parameters?A: James Hamilton (CMO & Head of R&D) stated that the team is focused on generating sNDA modules and study reports to file by the end of the year, with a pre-sNDA meeting with the FDA planned. He declined to comment on specific safety data details, citing the embargo until the ESC presentation. Q: What top-line data will you share from the ARO-MAP-T Phase 1 study in September, and what level of target knockdown are you looking for?A: James Hamilton (CMO & Head of R&D) explained that the September readout will be from healthy volunteers, focusing on safety and total tau knockdown as the primary pharmacodynamic biomarker. He reiterated that the benchmark for success remains a 50% to 60% knockdown, a level that has shown clinical improvements in other studies. Q: How will you scale the sales force for the potential SHTG launch, and what is the sequencing over the next several months?A: Andy Davis (SVP & Head of Global Cardiometabolic Franchise) stated that the field force will expand from addressing over 5,000 HCP targets to over 20,000, including specialists and primary care physicians who act like specialists. The final onboarding and optimization of the field force is expected to be completed before the end of the year to prepare for a potential accelerated SHTG launch in Q2 2027. Q: What proportion of patients in SHASTA-3 and SHASTA-4 received an MRI to assess liver fat, and will you continue the SHASTA-5 trial?A: James Hamilton (CMO & Head of R&D) declined to provide details on the MRI subgroup, citing the embargo. He confirmed that there are no plans to terminate the SHASTA-5 study at this time, and it will continue to run without changes until the label is better understood. Q: Which triglyceride responder analysis is more important for establishing plozasiran's value, and will the priority review voucher allow for Part D coverage for most of 2027?A: James Hamilton (CMO & Head of R&D) noted that the 500 mg/dL threshold is key for reducing acute pancreatitis risk, while Chris Anzalone (CEO) added that both 150 and 500 mg/dL thresholds are important, as normalizing a large percentage of patients is an attractive goal. Andy Davis (SVP) stated that the market access team will interact with payers as soon as data is published to prepare for policy development and coverage throughout 2027. Q: How do you see the difference in prescribing between the U.S. and European markets for SHTG, and how much of the $3-4 billion peak sales estimate is U.S.-based?A: Chris Anzalone (CEO) stated that the overwhelming majority of the peak sales estimate is U.S.-based. Andy Davis (SVP) added that European markets are very outcomes-based, making the statistically significant reduction in acute pancreatitis events from the pooled analysis incredibly important for demonstrating value, though the MFN uncertainty makes it difficult to project ex-U.S. revenue. Q: With the Ionis launch underway, how should we think about the right analogs for the SHTG commercial opportunity, and how important are the initial quarters for validating the market size?A: Andy Davis (SVP) emphasized the importance of getting out of the gates quickly, focusing on educating providers and working with payers to accelerate the ramp. He noted a high degree of overlap between FCS and SHTG prescribers, which bodes well for the ramp. Chris Anzalone (CEO) added that SHTG is a large market opportunity, but the launch will be a relatively slow ramp as it is a brand-new market requiring significant education. Q: What is the current weekly prescription run rate for Redemplo, and has the prescription-to-drug conversion rate hit steady state?A: Andy Davis (SVP) confirmed the run rate is approximately 20-30 new prescriptions per week, consistent with prior disclosures. He noted that the market access team is working hard to navigate prior authorizations and appeals, and with new field personnel onboarding this month, he expects an inflection point in both prescriptions and the conversion funnel to patient shipments. Q: Will the SHTG launch be segmented to the highest-risk patients or broader across patients with TGs above 500, and how will this reflect on the commercial build?A: Andy Davis (SVP) stated that while the data supports Redemplo across the spectrum of SHTG patients, the initial focus will be on high-risk patients with the highest unmet need and payer willingness to pay. Chris Anzalone (CEO) added that the data shows it's important to lower triglycerides for anyone above 500 mg/dL, as pancreatitis events occurred in patients below 880 mg/dL, but the broader market will require time and education. Q: How are you thinking about price differential versus the competitor now that you have the SHASTA data?A: Andy Davis (SVP) declined to discuss pricing or contracting strategy but noted the $45,000 WAC is justified by the product's efficacy, safety, and convenience. Chris Anzalone (CEO) confirmed there are no plans to change the price, citing the better safety profile, greater TG reduction, quarterly dosing, lack of liver enzyme monitoring, and simple 25 mg dose as reasons for the premium. Q: What other CNS targets are you excited about if the ARO-MAP-T Phase 1 data is positive?A: James Hamilton (CMO & Head of R&D) stated that the company has many undisclosed targets in its preclinical pipeline. He noted that wholly owned programs will likely not be disclosed until around the time of CTA filing due to the competitive nature of the siRNA space. Q: What are the plans for marketing Redemplo in the newly approved geographies (U.S., Canada, Australia, Europe), and how will revenue be recognized?A: Andy Davis (SVP) explained that Arrowhead is marketing directly in those countries using commercial partners, with the exception of China, where San For the complete transcript of the earnings call, please refer to the full earnings call transcript.

Investor releaseQuarter not tagged2026-08-03

4 Biotech Stocks Likely to Outpace Q2 Earnings Estimates

Zacks
The second-quarter 2026 earnings season is currently in full swing. The scorecard for the Medical sector is pretty good so far. The sector primarily comprises pharma/biotech and medical device companies. The earnings season for the pharma/biotech sector kicked off last month when pharma bellwether Johnson & Johnson posted better-than-expected results and upped its annual guidance. Swiss pharma giant Novartis also beat on earnings and sales in the second quarter. On the biotech front, Bristol-Myers (BMY) beat earnings and revenue estimates, driven by Growth Portfolio strength and Eliquis demand. Biogen also posted strong results, beating both earnings and sales estimates. The Earnings Trends report indicates that, as of July 29, 10.2% of the companies in the Medical sector, representing about 32.2% of the sector’s market capitalization, have reported quarterly earnings. While 100% of the companies topped on earnings, 94.7% beat on sales. While earnings increased 18.1% year over year, sales grew 6.8%. Overall, second-quarter earnings are expected to fall 15.2% year over year, while revenues are likely to rise 6.1%. Even though some of the bigwigs from the biotech sector have already announced results, there are many companies that are yet to report. Some of them seem poised to surpass estimates for the quarter. Here, we have highlighted four biotech companies, Arcutis Biotherapeutics ARQT, Nuvation Bio NUVB, Perspective Therapeutics, Inc. CATX and Tango Therapeutics TNGX — that are expected to deliver a beat in their upcoming quarterly results. Earnings ESP is our proprietary methodology for determining the stocks with the best chance of delivering an earnings surprise. It shows the percentage difference between the Most Accurate Estimate and the Zacks Consensus Estimate. According to the Zacks model, the combination of a positive Earnings ESP and a Zacks Rank #1 (Strong Buy), 2 (Buy) or 3 (Hold) increases the odds of an earnings beat. The selection can be made with the help of the Zacks Stock Screener. Our research shows that the chance of an earnings surprise for stocks with this combination is as high as 70%. You can uncover the best stocks to buy or sell before they’re reported with our Earnings ESP Filter. Arcutis Biotherapeutics, a commercial-stage medical dermatology, has a growing portfolio of advanced targeted topicals approved to treat three major in…Read full document

The second-quarter 2026 earnings season is currently in full swing. The scorecard for the Medical sector is pretty good so far. The sector primarily comprises pharma/biotech and medical device companies. The earnings season for the pharma/biotech sector kicked off last month when pharma bellwether Johnson & Johnson posted better-than-expected results and upped its annual guidance. Swiss pharma giant Novartis also beat on earnings and sales in the second quarter. On the biotech front, Bristol-Myers (BMY) beat earnings and revenue estimates, driven by Growth Portfolio strength and Eliquis demand. Biogen also posted strong results, beating both earnings and sales estimates. The Earnings Trends report indicates that, as of July 29, 10.2% of the companies in the Medical sector, representing about 32.2% of the sector’s market capitalization, have reported quarterly earnings. While 100% of the companies topped on earnings, 94.7% beat on sales. While earnings increased 18.1% year over year, sales grew 6.8%. Overall, second-quarter earnings are expected to fall 15.2% year over year, while revenues are likely to rise 6.1%. Even though some of the bigwigs from the biotech sector have already announced results, there are many companies that are yet to report. Some of them seem poised to surpass estimates for the quarter. Here, we have highlighted four biotech companies, Arcutis Biotherapeutics ARQT, Nuvation Bio NUVB, Perspective Therapeutics, Inc. CATX and Tango Therapeutics TNGX — that are expected to deliver a beat in their upcoming quarterly results. Earnings ESP is our proprietary methodology for determining the stocks with the best chance of delivering an earnings surprise. It shows the percentage difference between the Most Accurate Estimate and the Zacks Consensus Estimate. According to the Zacks model, the combination of a positive Earnings ESP and a Zacks Rank #1 (Strong Buy), 2 (Buy) or 3 (Hold) increases the odds of an earnings beat. The selection can be made with the help of the Zacks Stock Screener. Our research shows that the chance of an earnings surprise for stocks with this combination is as high as 70%. You can uncover the best stocks to buy or sell before they’re reported with our Earnings ESP Filter. Arcutis Biotherapeutics, a commercial-stage medical dermatology, has a growing portfolio of advanced targeted topicals approved to treat three major inflammatory skin diseases. Continued robust demand for flagship product, Zoryve, is boosting top-line revenue growth. ARQT has an Earnings ESP of +52.94% and a Zacks rank 2. The Zacks Consensus Estimate for the to-be-reported quarter’s revenues is pegged at $121.85 million, while the same for earnings is pinned at 9 cents per share. Arcutis Biotherapeutics, Inc. price-consensus-eps-surprise-chart | Arcutis Biotherapeutics, Inc. Quote ARQT is scheduled to report second-quarter results on Aug. 5. Nuvation Bio is a global oncology company focused on developing innovative therapies for difficult-to-treat cancers. Its pipeline includes taletrectinib (IBTROZI), a next-generation ROS1 inhibitor; safusidenib, a brain-penetrant IDH1 inhibitor; and a novel drug-drug conjugate (DDC) program, all aimed at improving outcomes for patients with cancer. NUVB has an Earnings ESP of +10.35% and a Zacks Rank of 2. The Zacks Consensus Estimate for revenues is pegged at $27.12 million, while the same for earnings is pinned at a loss of 15 cents per share. Nuvation Bio Inc. price-consensus-eps-surprise-chart | Nuvation Bio Inc. Quote NUVB is scheduled to report second-quarter results on Aug. 6. Perspective Therapeutics is a radiopharmaceutical development company pioneering advanced treatments for cancers throughout the body. The company is advancing a portfolio of clinical-stage programs in the United States, including VMT-α-NET (neuroendocrine tumors), VMT01 (melanoma), and PSV359 (solid tumors). CATX has an Earnings ESP of +1.89% and a Zacks Rank of 2. The Zacks Consensus Estimate for revenues is pegged at $0.2 million, while the same for earnings is pinned at a loss of 27 cents per share. Perspective Therapeutics, Inc. price-consensus-eps-surprise-chart | Perspective Therapeutics, Inc. Quote CATX is scheduled to report second-quarter results on Aug. 10. Tango Therapeutics is a clinical-stage biotechnology company focused on discovering novel cancer drug targets and developing next-generation precision medicines. The company is advancing two selective PRMT5 inhibitors targeting MTAP-deleted cancers. TNGX’s lead candidate, vopimetostat (TNG462), is being evaluated for non-central nervous system (non-CNS) cancers as both a monotherapy and in combination with RAS inhibitors. The company's second candidate, TNG456, is a next-generation, brain-penetrant PRMT5 inhibitor being developed for central nervous system (CNS) cancers, including glioblastoma (GBM). The company has an Earnings ESP of +1.06% and a Zacks Rank #2 at present. You can see the complete list of today’s Zacks #1 Rank stocks here. Tango Therapeutics, Inc. price-consensus-eps-surprise-chart | Tango Therapeutics, Inc. Quote The Zacks Consensus Estimate for second-quarter earnings is pegged at a loss of 31 cents per share. Tango Therapeutics beat on earnings in two of the trailing four quarters and met in the remaining two, delivering an average surprise of 301.61%. 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 Arcutis Biotherapeutics, Inc. (ARQT) : Free Stock Analysis Report Nuvation Bio Inc. (NUVB) : Free Stock Analysis Report Tango Therapeutics, Inc. (TNGX) : Free Stock Analysis Report Perspective Therapeutics, Inc. (CATX) : Free Stock Analysis Report This article originally published on Zacks Investment Research (zacks.com). Zacks Investment Research

Investor releaseQuarter not tagged2026-07-31

ALNY Stock Tanks 28% as Q2 Earnings Miss Estimates, '26 Sales View Cut

Zacks
Alnylam Pharmaceuticals ALNY reported second-quarter 2026 adjusted earnings of $1.84 per share, missing the Zacks Consensus Estimate of $2.05. The company had reported adjusted earnings of 28 cents in the year-ago quarter. Alnylam recorded total revenues of $1.29 billion in the quarter, missing the Zacks Consensus Estimate of $1.32 billion. In the year-ago quarter, total revenues were $773.7 million. The top line rose 67% year over year on a reported basis and at a constant exchange rate (CER), mainly driven by increased sales of its lead drug, Amvuttra (vutrisiran), following label expansion. ALNY stock declined 28.3% on Thursday as investors were likely disappointed by the dismal second-quarter performance and the downward revision of total product sales guidance. Net product revenues increased 74% on a reported basis and at CER to $1.17 billion, driven by strong growth in patient demand for Amvuttra and its other marketed drugs, Givlaari (givosiran) and Oxlumo (lumasiran). Amvuttra is approved in the United States and EU to treat adult patients with polyneuropathy of hATTR amyloidosis (hATTR-PN). A label expansion for the drug has also been approved in the United States and the EU for treating cardiomyopathy of wild-type or hereditary transthyretin-mediated amyloidosis (ATTR-CM) in adults to reduce cardiovascular mortality, cardiovascular hospitalizations and urgent heart failure visits. Amvuttra generated sales of $1.01 billion, up 106% year over year, driven by increased patient demand, mainly among ATTR-CM patients in the United States. This marked the first time Amvuttra revenues exceeded $1 billion in a quarter. Amvuttra sales, however, missed the Zacks Consensus Estimate of $1.05 billion. Onpattro sales declined 65% year over year to $18.5 million as patients continued transitioning to Amvuttra. Onpattro sales missed the Zacks Consensus Estimate of $24.2 million. Givlaari, approved for the treatment of acute hepatic porphyria, sales increased 11% year over year on a reported basis to $89.8 million, supported by growth in the number of patients receiving treatment. Givlaari sales beat the Zacks Consensus Estimate of $82.6 million. Oxlumo revenues also rose 11% on a reported basis to $52.1 million. Oxlumo sales missed the Zacks Consensus Estimate of $53.7 million. Collaboration revenues declined 23% year over year to $47.2 million. Lower revenues reco…Read full document

Alnylam Pharmaceuticals ALNY reported second-quarter 2026 adjusted earnings of $1.84 per share, missing the Zacks Consensus Estimate of $2.05. The company had reported adjusted earnings of 28 cents in the year-ago quarter. Alnylam recorded total revenues of $1.29 billion in the quarter, missing the Zacks Consensus Estimate of $1.32 billion. In the year-ago quarter, total revenues were $773.7 million. The top line rose 67% year over year on a reported basis and at a constant exchange rate (CER), mainly driven by increased sales of its lead drug, Amvuttra (vutrisiran), following label expansion. ALNY stock declined 28.3% on Thursday as investors were likely disappointed by the dismal second-quarter performance and the downward revision of total product sales guidance. Net product revenues increased 74% on a reported basis and at CER to $1.17 billion, driven by strong growth in patient demand for Amvuttra and its other marketed drugs, Givlaari (givosiran) and Oxlumo (lumasiran). Amvuttra is approved in the United States and EU to treat adult patients with polyneuropathy of hATTR amyloidosis (hATTR-PN). A label expansion for the drug has also been approved in the United States and the EU for treating cardiomyopathy of wild-type or hereditary transthyretin-mediated amyloidosis (ATTR-CM) in adults to reduce cardiovascular mortality, cardiovascular hospitalizations and urgent heart failure visits. Amvuttra generated sales of $1.01 billion, up 106% year over year, driven by increased patient demand, mainly among ATTR-CM patients in the United States. This marked the first time Amvuttra revenues exceeded $1 billion in a quarter. Amvuttra sales, however, missed the Zacks Consensus Estimate of $1.05 billion. Onpattro sales declined 65% year over year to $18.5 million as patients continued transitioning to Amvuttra. Onpattro sales missed the Zacks Consensus Estimate of $24.2 million. Givlaari, approved for the treatment of acute hepatic porphyria, sales increased 11% year over year on a reported basis to $89.8 million, supported by growth in the number of patients receiving treatment. Givlaari sales beat the Zacks Consensus Estimate of $82.6 million. Oxlumo revenues also rose 11% on a reported basis to $52.1 million. Oxlumo sales missed the Zacks Consensus Estimate of $53.7 million. Collaboration revenues declined 23% year over year to $47.2 million. Lower revenues recognized under the Regeneron REGN collaboration more than offset increased revenues from Roche RHHBY. The increase in Roche revenues reflected higher reimbursable development activities related to the phase III ZENITH study of zilebesiran, which will evaluate zilebesiran to treat patients with hypertension at high cardiovascular risk. ALNY entered a strategic collaboration with RHHBY to co-develop and co-commercialize zilebesiran for the treatment of hypertension in 2023. Year to date, Alnylam shares have plunged 48.3% against the industry’s 2.8% growth. Image Source: Zacks Investment Research Alnylam, in collaboration with Regeneron, is advancing cemdisiran as a monotherapy and in combination studies for the treatment of complement-mediated diseases. Per Regeneron, regulatory filings in the United States and the EU for cemdisiran in AChR antibody-positive generalized myasthenia gravis are currently under review. An FDA decision is expected in November 2026, while an EU decision is anticipated in the second half of 2027. Per the 2019 agreement, ALNY and REGN are also currently advancing multiple other programs. Royalty revenues jumped 79% to $71.7 million, driven by increased volumes and royalty rates on global Leqvio sales by Novartis NVS. Alnylam has granted Novartis exclusive global rights to manufacture and commercialize RNAi therapeutics targeting PCSK9, including Leqvio, for the treatment of hypercholesterolemia and other diseases. The FDA has approved Leqvio for several heart disease indications, alongside diet and statins. As of June 2026, Leqvio is approved in more than 109 countries. Adjusted research and development (R&D) expenses increased 38% year over year to $377.2 million. The rise primarily reflected increased clinical study costs associated with the ZENITH phase III cardiovascular outcomes study in partnership with Roche. Increased expenses associated with the phase III TRITON-CM and TRITON-PN studies, evaluating nucresiran in patients with ATTR-CM and hATTR-PN, respectively, also contributed to higher R&D costs. The company also increased spending on programs targeting bleeding disorders, Huntington's disease and cerebral amyloid angiopathy. Adjusted selling, general and administrative (SG&A) expenses rose 14% to $297.2 million, mainly due to investments supporting the global Amvuttra launch in ATTR-CM. Despite higher expenses, adjusted operating income increased to $318.1 million from $95.5 million in the year-ago quarter. Product gross margin was 75%, down four percentage points year over year due primarily to higher royalties payable on Amvuttra sales. Cash, cash equivalents and marketable securities totaled $3.3 billion as of June 30, 2026, compared with $3 billion as of March 31, 2026. The increase was primarily driven by net cash inflows from operating activities. Management said Amvuttra access remained broad, while patient adherence continued to exceed 90%. First-line patients now represent about 80% of new treatment initiations in the ATTR-CM market. Alnylam is increasing customer-facing investments to broaden the drug's prescriber base. Management estimated that only about one-third of the growing pool of transthyretin prescribers has used Amvuttra, indicating room to expand physician adoption. Alnylam Pharmaceuticals, Inc. price-consensus-eps-surprise-chart | Alnylam Pharmaceuticals, Inc. Quote Alnylam lowered its 2026 net product revenue guidance to $4.7-$5.1 billion from $4.9-$5.3 billion. The revised range implies year-over-year growth of 57-71% at CER. The company reduced its combined Amvuttra and Onpattro revenue forecast to $4.2-$4.5 billion from $4.4-$4.7 billion. Management attributed the cut to normalized second-line Amvuttra demand after early launch volumes benefited from pent-up demand among patients progressing on stabilizer therapy. Alnylam reiterated its Givlaari and Oxlumo revenue forecast of $500-$600 million and adjusted R&D and SG&A expense guidance of $2.7-$2.8 billion. The company raised its collaboration and royalty revenue outlook to $575-$625 million from $400-$500 million. The upward revision reflects stronger Leqvio royalties and higher Roche reimbursements tied to enrollment progress in the ZENITH study. Alnylam's second-quarter results disappointed, with both earnings and revenues missing expectations, triggering a sharp selloff in the stock. Although total revenues surged year over year, fueled by blockbuster Amvuttra sales that exceeded $1 billion for the first time, the drug still fell short of consensus estimates. Higher R&D spending on late-stage pipeline programs and increased commercialization investments further weighed on the quarter, overshadowing continued strength in Givlaari, Oxlumo and Leqvio royalty revenues. Investor sentiment was further dented by management's decision to lower its 2026 product sales guidance, reflecting a normalization in Amvuttra demand following the initial surge from previously untreated ATTR-CM patients. While Alnylam continues to highlight broad market access, strong patient adherence and significant room for physician adoption, the guidance cut suggests that near-term growth could be slower than previously anticipated. We believe the company's long-term growth story remains intact, but the reduced outlook is likely to weigh on the stock until Amvuttra's commercial momentum reaccelerates. Alnylam currently carries a Zacks Rank #3 (Hold). You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here. 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 Alnylam Pharmaceuticals, Inc. (ALNY) : Free Stock Analysis Report Regeneron Pharmaceuticals, Inc. (REGN) : Free Stock Analysis Report Novartis AG (NVS) : Free Stock Analysis Report Roche Holding AG (RHHBY) : Free Stock Analysis Report This article originally published on Zacks Investment Research (zacks.com). Zacks Investment Research

Investor releaseQuarter not tagged2026-07-30

Alnylam Pharmaceuticals Inc (ALNY) (Q2 2026) Earnings Call Highlights: Amvuttra Surpasses $1 ...

GuruFocus.com
This article first appeared on GuruFocus. Total Global Net Product Revenues: Approximately $1.2 billion, representing 74% growth versus Q2 last year. Global TTR Net Revenues (Amvutra): $1.03 billion in Q2, increasing 13% versus Q1 and 89% year-over-year. Rare Disease Net Revenue: $142 million in Q2, up 11% year-over-year. Collaboration Revenue: $47 million in Q2, a 23% decrease compared to the same period last year. Royalty Revenue: $72 million in Q2, an increase of 79% driven by higher Leqvio sales by Novartis. Gross Margin on Product Sales: 75% in Q2, 4% lower than Q2 last year. Non-GAAP R&D Expenses: $377 million in Q2, increased 38% compared to last year. Non-GAAP SG&A Expenses: $297 million in Q2, increased 14% compared to last year. Non-GAAP Operating Income: $318 million in Q2, more than triple the amount achieved last year. Cash Equivalents and Marketable Securities: $3.3 billion as of Q2 2026, compared with $2.9 billion as of year-end 2025. Full Year 2026 Total Net Product Revenue Guidance: Revised to $4.7 billion to $5.1 billion. Full Year 2026 TTR Revenue Guidance: Revised to $4.2 billion to $4.5 billion. Full Year 2026 Collaboration and Royalty Revenue Guidance: Updated to $575 million to $625 million. Warning! GuruFocus has detected 3 Warning Sign with ALNY. Is ALNY fairly valued? Test your thesis with our free DCF calculator. Release Date: July 30, 2026 For the complete transcript of the earnings call, please refer to the full earnings call transcript. Alnylam Pharmaceuticals Inc (NASDAQ:ALNY) reported strong Q2 2026 performance with total global net product revenues of approximately $1.2 billion, representing 74% year-over-year growth. Amvutra revenues exceeded $1 billion in a single quarter for the first time, achieving an annual run rate of more than $4 billion just 15 months into the ATTR Cardiomyopathy launch. First-line new patient starts now account for about 80% of category growth, indicating strong progress in establishing Ambutra as a foundational therapy. The company maintains strong confidence in its Phase III Triton-CM study for nucrisiran, citing the established clinical evidence for RNAi therapeutics in TTR and a track record of successful clinical development. Alnylam announced a strategic collaboration with B1 for exclusive commercialization and distribution rights for Ambutra in mainland China and Macau, expanding its geograph…Read full document

This article first appeared on GuruFocus. Total Global Net Product Revenues: Approximately $1.2 billion, representing 74% growth versus Q2 last year. Global TTR Net Revenues (Amvutra): $1.03 billion in Q2, increasing 13% versus Q1 and 89% year-over-year. Rare Disease Net Revenue: $142 million in Q2, up 11% year-over-year. Collaboration Revenue: $47 million in Q2, a 23% decrease compared to the same period last year. Royalty Revenue: $72 million in Q2, an increase of 79% driven by higher Leqvio sales by Novartis. Gross Margin on Product Sales: 75% in Q2, 4% lower than Q2 last year. Non-GAAP R&D Expenses: $377 million in Q2, increased 38% compared to last year. Non-GAAP SG&A Expenses: $297 million in Q2, increased 14% compared to last year. Non-GAAP Operating Income: $318 million in Q2, more than triple the amount achieved last year. Cash Equivalents and Marketable Securities: $3.3 billion as of Q2 2026, compared with $2.9 billion as of year-end 2025. Full Year 2026 Total Net Product Revenue Guidance: Revised to $4.7 billion to $5.1 billion. Full Year 2026 TTR Revenue Guidance: Revised to $4.2 billion to $4.5 billion. Full Year 2026 Collaboration and Royalty Revenue Guidance: Updated to $575 million to $625 million. Warning! GuruFocus has detected 3 Warning Sign with ALNY. Is ALNY fairly valued? Test your thesis with our free DCF calculator. Release Date: July 30, 2026 For the complete transcript of the earnings call, please refer to the full earnings call transcript. Alnylam Pharmaceuticals Inc (NASDAQ:ALNY) reported strong Q2 2026 performance with total global net product revenues of approximately $1.2 billion, representing 74% year-over-year growth. Amvutra revenues exceeded $1 billion in a single quarter for the first time, achieving an annual run rate of more than $4 billion just 15 months into the ATTR Cardiomyopathy launch. First-line new patient starts now account for about 80% of category growth, indicating strong progress in establishing Ambutra as a foundational therapy. The company maintains strong confidence in its Phase III Triton-CM study for nucrisiran, citing the established clinical evidence for RNAi therapeutics in TTR and a track record of successful clinical development. Alnylam announced a strategic collaboration with B1 for exclusive commercialization and distribution rights for Ambutra in mainland China and Macau, expanding its geographic reach. Alnylam Pharmaceuticals Inc (NASDAQ:ALNY) lowered its 2026 total net product revenue guidance to $4.7 billion to $5.1 billion, driven by a $200 million reduction in TTR revenue guidance at the midpoint. The guidance revision was attributed to a normalization of second-line demand growth, which had previously benefited from pent-up demand that has since moderated. The company acknowledged it did not get its original guidance right, stating, 'We own that,' regarding the need to adjust market expectations. Gross margin on product sales decreased to 75%, down 4% from Q2 last year, primarily due to increased royalties payable to Sanofi on higher Ambutra revenues. The negative outcome of the Cardio-Transform study for Eplontersen introduces uncertainty in the competitive landscape, though Alnylam asserts it does not alter its confidence in its own programs. Here are the key highlights from the Alnylam Pharmaceuticals Inc (NASDAQ:ALNY) Q2 2026 earnings call. Q: Can you elaborate on the change in 2026 revenue guidance and your confidence in the long-term 25% CAGR goal? A: (Yvonne Greenstreet, CEO; Jeff Poulton, CFO; Tolga Tanguler, CCO) The guidance revision reflects a better understanding of second-line demand dynamics. Early launch growth benefited from pent-up demand from patients waiting for a new therapy, which has now normalized. However, the fundamentals are strong, with first-line new patient starts now driving ~80% of category growth. The company remains confident in its 2030 goals due to a highly untapped market (80% of patients untreated), strong first-line momentum, and a favorable competitive landscape following the CardioTransform failure. Q: What is your confidence in the Triton-CM study for nucrisiran following the failure of the CardioTransform study for eplontersen? A: (Pushkal Garg, Chief R&D Officer) The outcome does not alter our conviction. Confidence is grounded in three factors: 1) Molecule attributes: RNAi therapeutics deliver rapid, deep, and durable TTR knockdown. Nucrisiran is expected to achieve >95% knockdown with low variability, with modeling suggesting >99% of patients will reach a deep knockdown threshold, compared to an estimated 67% for eplontersen. 2) Study design: Triton-CM is an event-driven study with 1,750 patients, the largest in ATTR-CM, and uses entry criteria to enrich for patients most likely to benefit. 3) Track record: Alnylam has over 15 years of TTR experience and has shown additive benefits of RNAi silencing on top of stabilizers in two separate studies (Helios-B and Apollo-B). Q: What is the split of Amvuttra use between first-line and second-line patients, and how do you plan to maintain growth in the first-line setting? A: (Tolga Tanguler, CCO) In Q2, approximately 80% of new treatment initiations in the category were first-line starts. While second-line demand has normalized, the company is maintaining a strong share of second-line starts. Growth is driven by deepening adoption among existing prescribers (Amvuttra now represents >50% of their new starts) and expanding the prescriber base. The company is increasing investment in customer-facing activities to educate community physicians on the differentiated profile of silencers versus stabilizers, as experience drives preference. Q: Are you seeing any commercial impact or payer pushback on combination use (silencer + stabilizer) following the CardioTransform results? A: (Tolga Tanguler, CCO) It is too early to see significant impact, but payer access for Amvuttra remains very strong. CardioTransform was a study of a different molecule and does not change Amvuttra's evidence or label. Payers are not expected to alter coverage based on those results. While some Medicare Advantage policies already limit combination use, physicians continue to have pathways to access for medically appropriate patients. Q: What are the potential options available to you to adapt the Triton-CM study to maximize its probability of success? A: (Pushkal Garg, Chief R&D Officer) While we may not need to change anything, we have options at our disposal. These fall into two buckets: 1) Modifying enrollment to further enrich for certain subpopulations, and 2) Making modifications to the analytic plan, such as the endpoint hierarchy. The company will review the full CardioTransform dataset and consider if any changes are warranted, emphasizing a long-term commitment to delivering a successful study. For the complete transcript of the earnings call, please refer to the full earnings call transcript.

Investor releaseQuarter not tagged2026-07-29

Why Biogen Stock Is Resisting a Market Downturn After Earnings

Barrons.com

Biogen’s growth portfolio, which includes one closely watched Alzheimer’s drug, is a bright spot in the second quarter.

Investor releaseQuarter not tagged2026-07-28

INCY Q2 Earnings & Revenues Beat on Higher Sales, '26 View Raised

Zacks
Incyte Corporation INCY reported second-quarter 2026 adjusted earnings of $3.09 per share, which beat the Zacks Consensus Estimate of $2.00, primarily due to higher product sales. The company had reported adjusted earnings of $1.57 per share in the year-ago quarter. Total revenues in the second quarter were $1.67 billion, which grew 38% year over year, driven primarily by the sustained performance of its lead drug, Jakafi (ruxolitinib), and increased sales of Opzelura (ruxolitinib) cream on strong launch and demand. The top line beat the Zacks Consensus Estimate of $1.46 billion. All percentages mentioned below are on a reported basis. Revenues from the sale of Jakafi, a first-in-class JAK1/JAK2 inhibitor approved for polycythemia vera, myelofibrosis and refractory acute graft-versus-host disease (GVHD), came in at $816.7 million, up 7% from the year-ago quarter, owing to a 9% increase in paid demand and growth across all indications. Jakafi's sales beat the Zacks Consensus Estimate of $798 million. Opzelura (ruxolitinib) cream, approved for atopic dermatitis and vitiligo, generated $449.7 million in sales, which rose 173% year over year, beating the Zacks Consensus Estimate of $277.8 million. The massive uptick was driven by a one-time, non-cash benefit of $246 million associated with the reversal of previously established accrual balances through March 31, 2026, for Opzelura, as well as by increased patient demand in both approved indications. The newly approved medicine Zynyz (retifanlimab-dlwr) generated sales of $49.9 million, which significantly increased from the year-ago quarter and beat the Zacks Consensus Estimate of $43.8 million. The company obtained accelerated approval for Zynyz to treat metastatic or recurrent locally advanced Merkel cell carcinoma. Net product revenues of Iclusig were $34.4 million, up 5% year over year. The figure missed the Zacks Consensus Estimate of $35.5 million. Pemazyre generated $23.4 million in sales, reflecting a year-over-year increase of 6%. The figure surpassed the Zacks Consensus Estimate of $22.4 million. Minjuvi's revenues totaled $53.7 million, up 72% year over year. The figure beat the Zacks Consensus Estimate of $50.6 million. Incyte gained exclusive global rights for tafasitamab from MorphoSys AG, which is marketed as Monjuvi in the United States and as Minjuvi in the ex-U.S. markets in 2024. Incyte and pa…Read full document

Incyte Corporation INCY reported second-quarter 2026 adjusted earnings of $3.09 per share, which beat the Zacks Consensus Estimate of $2.00, primarily due to higher product sales. The company had reported adjusted earnings of $1.57 per share in the year-ago quarter. Total revenues in the second quarter were $1.67 billion, which grew 38% year over year, driven primarily by the sustained performance of its lead drug, Jakafi (ruxolitinib), and increased sales of Opzelura (ruxolitinib) cream on strong launch and demand. The top line beat the Zacks Consensus Estimate of $1.46 billion. All percentages mentioned below are on a reported basis. Revenues from the sale of Jakafi, a first-in-class JAK1/JAK2 inhibitor approved for polycythemia vera, myelofibrosis and refractory acute graft-versus-host disease (GVHD), came in at $816.7 million, up 7% from the year-ago quarter, owing to a 9% increase in paid demand and growth across all indications. Jakafi's sales beat the Zacks Consensus Estimate of $798 million. Opzelura (ruxolitinib) cream, approved for atopic dermatitis and vitiligo, generated $449.7 million in sales, which rose 173% year over year, beating the Zacks Consensus Estimate of $277.8 million. The massive uptick was driven by a one-time, non-cash benefit of $246 million associated with the reversal of previously established accrual balances through March 31, 2026, for Opzelura, as well as by increased patient demand in both approved indications. The newly approved medicine Zynyz (retifanlimab-dlwr) generated sales of $49.9 million, which significantly increased from the year-ago quarter and beat the Zacks Consensus Estimate of $43.8 million. The company obtained accelerated approval for Zynyz to treat metastatic or recurrent locally advanced Merkel cell carcinoma. Net product revenues of Iclusig were $34.4 million, up 5% year over year. The figure missed the Zacks Consensus Estimate of $35.5 million. Pemazyre generated $23.4 million in sales, reflecting a year-over-year increase of 6%. The figure surpassed the Zacks Consensus Estimate of $22.4 million. Minjuvi's revenues totaled $53.7 million, up 72% year over year. The figure beat the Zacks Consensus Estimate of $50.6 million. Incyte gained exclusive global rights for tafasitamab from MorphoSys AG, which is marketed as Monjuvi in the United States and as Minjuvi in the ex-U.S. markets in 2024. Incyte and partner Syndax Pharmaceuticals obtained FDA approval for axatilimab-csfr, an anti-CSF-1R antibody, for the treatment of GVHD after the failure of at least two prior lines of systemic therapy in adult and pediatric patients weighing at least 40 kg. The candidate was approved under the brand name Niktimvo. The drug is Incyte’s second approved treatment for chronic GVHD (third-line) and was launched in the United States during the first quarter of 2025. The drug recorded $60.3 million in sales in the second quarter of 2026, up 67% on a year-over-year basis, driven by strong uptake, but missed the Zacks Consensus Estimate of $63.8 million. Shares of Incyte have rallied 20.3% year to date compared with the industry’s 2% growth. Image Source: Zacks Investment Research Jakafi is marketed by Incyte in the United States and by Novartis NVS as Jakavi in ex-U.S. markets. Jakavi royalty revenues from Novartis for commercialization in ex-U.S. markets rose 13% to $124.2 million. Jakavi royalties beat the Zacks Consensus Estimate of $117 million. Incyte also receives royalties from the sales of Tabrecta (capmatinib) for the treatment of adult patients with metastatic non-small-cell lung cancer. Its partner, Novartis, has exclusive worldwide development and commercialization rights for Tabrecta. Royalty revenues from the drug’s sales amounted to $6.7 million, up 1% year over year. The reported figure missed the Zacks Consensus Estimate of $7.1 million. Olumiant’s (baricitinib) product royalty revenues from Eli Lilly LLY totaled $38.5 million, up 15% year over year. The figure beat the Zacks Consensus Estimate of $36.9 million. Incyte has a collaboration agreement with Eli Lilly for Olumiant. The drug is a once-daily oral JAK inhibitor discovered by Incyte and licensed to LLY. It is approved for several types of autoimmune diseases. Adjusted research and development (R&D) expenses totaled $478.8 million, up 5% year over year. This increase was primarily due to continued investment in late-stage development assets. Adjusted selling, general and administrative (SG&A) expenses were $323.6 million, up 6% from the prior-year quarter’s number, primarily due to increased consumer marketing and pre-launch activities. INCY’s cash, cash equivalents and marketable securities amounted to $4.5 billion as of June 30, 2026, compared with the $4 billion recorded as of March 31, 2026. Incyte Corporation price-consensus-eps-surprise-chart | Incyte Corporation Quote While Incyte continues to expect Jakafi revenues in the range of $3.22-$3.27 billion in 2026, it now expects Opzelura net product revenues to be in the range of $1.05-$1.1 billion, up from the previously guided range of $750-$790 million. Net product revenues for 2026 are now expected to be in the range of $5.13-$5.26 billion, up from the previously guided range of $4.77-$4.94 billion. Total adjusted R&D expenses and SG&A expenses for 2026 are now expected in the range of$4.625 - $4.695 billion compared with the previous guidance of $3.205-$3.375 billion. Incyte currently carries a Zacks Rank #3 (Hold). A better-ranked stock in the biotech sector is Neurocrine Biosciences NBIX,carrying a Zacks Rank #2 (Buy) at present. You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here. Over the past 60 days, estimates for Neurocrine Biosciences’ 2026 earnings per share have decreased from $9.15 to $9.09. Over the same period, EPS estimates for 2027 have increased from $10.23 to $10.81. NBIX shares have gained 24.4% year to date. Neurocrine Biosciences’ earnings beat estimates in three of the trailing four quarters and missed in the remaining one, the average surprise being 9.08%. 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 Incyte Corporation (INCY) : Free Stock Analysis Report Novartis AG (NVS) : Free Stock Analysis Report Eli Lilly and Company (LLY) : Free Stock Analysis Report Neurocrine Biosciences, Inc. (NBIX) : Free Stock Analysis Report This article originally published on Zacks Investment Research (zacks.com). Zacks Investment Research

Investor releaseQuarter not tagged2026-07-27

Watch These 5 Biotech Stocks for Q2 Earnings: Beat or Miss?

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The second-quarter 2026 reporting cycle for the Medical sector is picking up pace. The sector primarily comprises pharma/biotech and medical device companies. The earnings season for the Medical sector kicked off earlier this month when pharma bellwether Johnson & Johnson posted encouraging earnings results. J&J also raised its 2026 outlook for the second time this year, driven by the strong performance of its Innovative Medicines/Pharma segment. Another large-cap company that recently reported impressive earnings results was Novartis, driven by strong demand for key growth brands. The Earnings Trends report indicates that, as of July 22, 10.2% of the companies in the Medical sector, representing about 25% of the sector’s market capitalization, have reported quarterly earnings. So far, all participants have outperformed both earnings and revenues. While earnings rose 14.6% year over year, sales increased 2.3%. Overall, second-quarter earnings are expected to fall 17.4% year over year, while revenues are expected to rise 5.2%. We have highlighted five biotech companies — Harmony Biosciences HRMY, Acadia Pharmaceuticals ACAD, Biogen BIIB, Insmed INSM and Agios Pharmaceuticals AGIO — that are expected to deliver a beat in their upcoming quarterly results. Earnings ESP is our proprietary methodology for determining the stocks with the best chance of delivering an earnings surprise. It shows the percentage difference between the Most Accurate Estimate and the Zacks Consensus Estimate. According to the Zacks model, the combination of a positive Earnings ESP and a Zacks Rank #1 (Strong Buy), 2 (Buy) or 3 (Hold) increases the odds of an earnings beat. The selection can be made with the help of the Zacks Stock Screener. Our research shows that the chance of an earnings surprise for stocks with this combination is as high as 70%. You can uncover the best stocks to buy or sell before they’re reported with our Earnings ESP Filter. HRMY is a commercial-stage company that develops and commercializes therapies for sleep/wake disorders and rare neurological diseases. The company has an Earnings ESP of +14.14% and a Zacks Rank #1 at present. You can see the complete list of today’s Zacks #1 Rank stocks here. The Zacks Consensus Estimate for second-quarter earnings is pegged at 97 cents per share. Harmony Biosciences missed on earnings in each of the trailing four quarters, d…Read full document

The second-quarter 2026 reporting cycle for the Medical sector is picking up pace. The sector primarily comprises pharma/biotech and medical device companies. The earnings season for the Medical sector kicked off earlier this month when pharma bellwether Johnson & Johnson posted encouraging earnings results. J&J also raised its 2026 outlook for the second time this year, driven by the strong performance of its Innovative Medicines/Pharma segment. Another large-cap company that recently reported impressive earnings results was Novartis, driven by strong demand for key growth brands. The Earnings Trends report indicates that, as of July 22, 10.2% of the companies in the Medical sector, representing about 25% of the sector’s market capitalization, have reported quarterly earnings. So far, all participants have outperformed both earnings and revenues. While earnings rose 14.6% year over year, sales increased 2.3%. Overall, second-quarter earnings are expected to fall 17.4% year over year, while revenues are expected to rise 5.2%. We have highlighted five biotech companies — Harmony Biosciences HRMY, Acadia Pharmaceuticals ACAD, Biogen BIIB, Insmed INSM and Agios Pharmaceuticals AGIO — that are expected to deliver a beat in their upcoming quarterly results. Earnings ESP is our proprietary methodology for determining the stocks with the best chance of delivering an earnings surprise. It shows the percentage difference between the Most Accurate Estimate and the Zacks Consensus Estimate. According to the Zacks model, the combination of a positive Earnings ESP and a Zacks Rank #1 (Strong Buy), 2 (Buy) or 3 (Hold) increases the odds of an earnings beat. The selection can be made with the help of the Zacks Stock Screener. Our research shows that the chance of an earnings surprise for stocks with this combination is as high as 70%. You can uncover the best stocks to buy or sell before they’re reported with our Earnings ESP Filter. HRMY is a commercial-stage company that develops and commercializes therapies for sleep/wake disorders and rare neurological diseases. The company has an Earnings ESP of +14.14% and a Zacks Rank #1 at present. You can see the complete list of today’s Zacks #1 Rank stocks here. The Zacks Consensus Estimate for second-quarter earnings is pegged at 97 cents per share. Harmony Biosciences missed on earnings in each of the trailing four quarters, delivering an average negative surprise of 25.16%. It is scheduled to report earnings on Aug. 4, before the opening bell. Harmony Biosciences Holdings, Inc. price-eps-surprise | Harmony Biosciences Holdings, Inc. Quote A commercial-stage company, ACAD, is focused on developing and marketing therapies for central nervous system disorders and rare diseases. The company has an Earnings ESP of +25.00% and a Zacks Rank #2 at present. The Zacks Consensus Estimate for second-quarter earnings is pegged at 6 cents per share. Acadia Pharmaceuticals beat on earnings in three of the trailing four quarters and missed the mark on one occasion, delivering an average surprise of 20.83%. The company is scheduled to release results on Aug. 4, after the market closes. ACADIA Pharmaceuticals Inc. price-eps-surprise | ACADIA Pharmaceuticals Inc. Quote BIIB is one of the world’s leading biotechs, focusing on developing innovative therapies for treating serious neurological and neurodegenerative diseases. The company has an Earnings ESP of +220.79% and a Zacks Rank #3 at present. The Zacks Consensus Estimate for second-quarter earnings is pegged at 94 cents per share. Biogen beat on earnings in each of the trailing four quarters, delivering an average surprise of 26.87%. It is scheduled to report earnings on July 29, before the opening bell. Biogen Inc. price-eps-surprise | Biogen Inc. Quote INSM is a commercial-stage biopharmaceutical company focused on the development of therapies targeting serious and rare indications. The company has an Earnings ESP of +22.32% and a Zacks Rank #3 at present. The Zacks Consensus Estimate for second-quarter earnings is pegged at a loss of 69 cents per share. Insmed missed on earnings in three of the trailing four quarters and beat the mark on one occasion, delivering an average negative surprise of 22.93%. The company is scheduled to release results on Aug. 6, before the opening bell. Insmed, Inc. price-eps-surprise | Insmed, Inc. Quote AGIO is a biopharmaceutical company focused on the development of treatments for rare genetic metabolic disorders, a subset of orphan genetic metabolic diseases. The company has an Earnings ESP of +12.67% and a Zacks Rank #3 at present. The Zacks Consensus Estimate for second-quarter earnings is pegged at a loss of $1.86 per share. Agios beat on earnings in three of the trailing four quarters and missed the mark on one occasion, delivering an average surprise of 2.39%. It is scheduled to report earnings on July 30, before the opening bell. Agios Pharmaceuticals, Inc. price-eps-surprise | Agios Pharmaceuticals, Inc. Quote 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 Biogen Inc. (BIIB) : Free Stock Analysis Report Insmed, Inc. (INSM) : Free Stock Analysis Report Agios Pharmaceuticals, Inc. (AGIO) : Free Stock Analysis Report ACADIA Pharmaceuticals Inc. (ACAD) : 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

As of 2026-09-05 • Updated weeklySource: Earnings sourceIngestion runbook