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Eli Lilly and Company’s LLY stock has risen 5.8% since it announced solid second-quarter results on Aug. 5. Lilly’s earnings and revenues comfortably exceeded estimates. Revenues rose 48% year over year to $22.97 billion while adjusted EPS rose 33% to $8.38. Mounjaro and Zepbound remained the primary growth engines, with both drugs beating their respective consensus estimates. Newer medicines also made meaningful contributions across immunology, oncology and neuroscience. The company also raised its sales expectations for the second time this year. However, a single quarter’s results are not so important for long-term investors. To make an informed decision on whether to buy, sell or hold the stock, it is important to evaluate the company’s fundamentals by examining its key strengths and weaknesses. Lilly has seen extraordinary momentum in its cardiometabolic franchise. Its blockbuster drugs, Mounjaro for type II diabetes and Zepbound for obesity, have become some of the fastest-growing medicines in pharmaceutical history, gaining from enormous global demand for GLP-1 therapies. These therapies account for around 65% of the company’s total revenues and have become key top-line drivers for Lilly, with demand rising rapidly. In the first half of 2026, the drugs generated combined sales of $27.6 billion. Robust growth trends in the U.S. incretin analogs market and positive uptake trends of Mounjaro and Zepbound in new international markets led to strong sales growth, with the positive trend expected to continue. On the call, Lilly said that though Mounjaro’s revenue growth was robust in the second quarter, future growth will depend increasingly on market expansion rather than share gains. Mounjaro and Zepbound are also consistently gaining approvals for new indications. Lilly’s newly launched once-daily oral GLP-1 pill, Foundayo (orforglipron) for treating obesity, generated $98 million in sales in the second quarter, its first full quarter on the market. Medicare access is becoming an increasingly important growth driver for Lilly's obesity portfolio. Eligible Medicare Part D beneficiaries gained access to Zepbound and Foundayo for weight management through the Medicare GLP-1 Bridge program beginning July 2026, while Mounjaro already has Medicare coverage for its type II diabetes indication. The obesity market is still in the early stages of expansion, with millions of eligible patients yet to begin treatment. As manufacturing capacity improves and global reimbursement gradually expands, Lilly has significant room to grow sales over the next several years. To maintain leadership in the GLP-1 market, Lilly is developing several next-generation, more powerful and more convenient GLP-1–based treatments, including oral options and multi-acting candidates. Foundayo, which offers the benefits of GLP-1 therapy in a pill form, can prove to be a commercial game-changer for Lilly. Oral pills will be a more convenient alternative to the currently available once-weekly injectable obesity treatments like Zepbound and rival Novo Nordisk’s NVO Wegovy. The launch uptake for Foundayo has been encouraging as Lilly expands physician engagement and direct-to-consumer promotion in the United States. Lilly has also secured coverage across all three major PBMs. Lilly is also continuing Foundayo’s international expansion. Foundayo is currently under regulatory review in more than 40 additional countries, with further approvals expected later this year. Lilly expects to launch Foundayo in most international markets by 2027. Lilly expects Foundayo to become a multi-indication cardiometabolic opportunity. For the type II diabetes indication, Lilly has filed regulatory applications in several countries, including the United States. In addition to obesity and type II diabetes, Lilly is also evaluating Foundayo in six phase III studies for other diabetes and obesity-related diseases, with data from some of these expected later this year. In its GLP pipeline, retatrutide is one of Lilly’s most important late-stage candidates, as it targets three biological pathways — GLP-1, GIP and glucagon — potentially offering greater weight-loss and metabolic benefits than existing medicines, which mostly act on one or two biological pathways. The company is evaluating retatrutide in type II diabetes and obesity, along with other indications like obstructive sleep apnea (OSA), knee osteoarthritis, chronic low back pain and MASH, in late-stage studies. Across its TRIUMPH program, retatrutide has demonstrated profound levels of weight loss and improvements in A1C, cardiovascular risk factors, osteoarthritis pain and sleep apnea. Lilly has completed the clinical data package needed to support global regulatory submissions for retatrutide in obesity, obstructive sleep apnea and knee osteoarthritis pain. The company plans to submit the treatment to the FDA in the first quarter of 2027. If approved, retatrutide could become another multibillion-dollar product. Lilly's investment case is no longer dependent solely on its GLP-1 franchise. Lilly has secured approvals for several non-GLP1 therapies over the past few years. These include Omvoh for treating ulcerative colitis and Crohn’s disease, BTK inhibitor Jaypirca for mantle cell lymphoma and chronic lymphocytic leukemia, Ebglyss for moderate-to-severe atopic dermatitis, Kisunla (donanemab) for early symptomatic Alzheimer’s disease and Inluriyo (imlunestrant) for metastatic breast cancer. These drugs are also contributing to Lilly’s revenue growth, with the positive trend expected to continue. Key product revenues outside cardiometabolic health grew 121% in the second quarter. Lilly has also embarked on an aggressive M&A spree in the past couple of years, acquiring biotech companies across oncology, neuroscience, cardiovascular disease, gene editing, inflammation, cell therapy and vaccines to diversify its long-term growth drivers beyond GLP-1 therapies. The company has announced more than $20 billion in biotech deals this year. Novo Nordisk had gained approval for an oral version of its obesity drug, Wegovy, in December 2025 and launched the pill in January 2026. Novo Nordisk announced sales of around $500 million (DKK 3.22 billion) from the Wegovy oral pill in its second-quarter results announced on Aug 4. Total prescriptions for Wegovy pill reached around 2.9 million in the second quarter. While Lilly and Novo Nordisk currently dominate this space, smaller biotechs like Structure Therapeutics GPCR and Viking Therapeutics VKTX are also developing oral GLP-1 drugs for treating obesity. Viking Therapeutics’ dual GIPR/GLP-1 receptor agonist, VK2735, is being developed both as oral and subcutaneous formulations for the treatment of obesity. Viking plans to advance oral VK2735 into phase III development for obesity in the fourth quarter of 2026. Structure Therapeutics recently initiated the phase III ACCOMPLISH program on its once-daily oral small molecule GLP-1 receptor agonist, aleniglipron. Lilly’s stock has risen 9.8% so far this year compared with the industry’s increase of 11.5% over the same timeframe. Image Source: Zacks Investment Research From a valuation standpoint, Lilly’s stock is expensive. Going by the price/earnings ratio, the company’s shares currently trade at 27.99 forward earnings, higher than 18.47 for the industry. However, the stock is trading below its 5-year mean of 34.57. Image Source: Zacks Investment Research The Zacks Consensus Estimate for 2026 has risen from $34.55 to $35.93 per share over the past 30 days, while that for 2027 has risen from $45.10 to $45.87 per share over the same timeframe. Image Source: Zacks Investment Research Lilly has its share of problems. Prices of most of Lilly’s products are declining in the United States.  Price is expected to continue to be a drag on top-line growth in the low to mid-teens percentage in 2026. Rising competition in the GLP-1 diabetes/obesity market is a key headwind. Also, sales of late-life cycle products like Trulicity, Taltz and Verzenio are expected to be flat to down in 2026. Also, second-half sales growth could be slower than in the first half, as the U.S. rebate/discount estimate adjustments that benefited first-half sales are not expected to recur in the second half. Moreover, the second half faces tougher comparisons from prior-year international launches and normal vacation seasonality in Europe. Moreover, U.S. diabetes has also historically shown fourth-quarter seasonality. Due to these factors, second-half percentage growth may appear to decelerate, though Lilly expects significant absolute-dollar growth in the second half. Nonetheless, Lilly remains one of the most compelling growth stories in the pharmaceutical industry, supported by its significant price appreciation, dominant position in the rapidly expanding obesity and diabetes markets, a diversified late-stage pipeline and strong financial performance. While the stock trades at a premium valuation after a remarkable multi-year rally, the company's long-term growth prospects remain among the strongest in the healthcare sector. An existing investor should stay invested in this Zacks Rank #3 (Hold) stock. You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here. New investors may consider accumulating on market corrections rather than buying aggressively at current levels. 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 Eli Lilly and Company (LLY) : Free Stock Analysis Report Novo Nordisk A/S (NVO) : Free Stock Analysis Report Viking Therapeutics, Inc. (VKTX) : Free Stock Analysis Report Structure Therapeutics Inc. Sponsored ADR (GPCR) : Free Stock Analysis Report This article originally published on Zacks Investment Research (zacks.com). Zacks Investment Research

All participants successfully dosed in SLIM-1™, the Company's first-in-human Phase 1 trial of NPM-139, a miniature, ultra long-acting semaglutide implant for chronic weight management; top-line data expected in November 2026 Company entered into non-exclusive agreement with Novo Nordisk to evaluate NPM-139 and Vivani's proprietary NanoPortal™ technology Completion of the Cortigent-ClearOne merger into Cortigent Holdings and initiation of trading on the Nasdaq exchange under ticker symbol CRGT anticipated in the third quarter of 2026 ALAMEDA, Calif., Aug. 13, 2026 (GLOBE NEWSWIRE) -- Vivani Medical, Inc. (Nasdaq: VANI) ("Vivani" or the "Company"), a clinical-stage biopharmaceutical company developing miniature, ultra long-acting drug implants utilizing its proprietary NanoPortal™ technology, today reported financial results for the second quarter ended June 30, 2026, and highlighted recent business progress. "I am very pleased with the progress and achievements that Vivani made in all aspects of our business during the second quarter of 2026. We accelerated clinical development of lead asset NPM-139 (semaglutide implant), entered into a non-exclusive agreement with Novo Nordisk enabling them to evaluate NPM-139, and signed a merger agreement with Nasdaq-listed ClearOne which, upon successful closing, would finance and establish our neurostimulation subsidiary Cortigent as a stand-alone publicly traded company," said Adam Mendelsohn, Ph.D., CEO of Vivani Medical. "We enrolled and dosed all 20 SLIM-1 participants ahead of schedule, with every insertion procedure completed successfully. We expect to be able to share top-line data in November, an exciting milestone that we anticipate will support advancing NPM-139 into a Phase 2 dose-ranging trial in 2027. Combined with the agreement with Novo Nordisk announced in July, these positive developments further strengthen our conviction in the potential of our pipeline to transform chronic disease management for the roughly half of patients who struggle with medication adherence. Today, Vivani remains the only developer of convenient, ultra-long-acting and reversible GLP-1 candidates with the potential for administration once or twice yearly during a routine primary care office visit." Vivani’s NanoPortal implant technology has the potential to enable patients to maintain continuous and therapeutic drug exposure levels with convenient once- or twice-yearly administration while still enabling the ability to rapidly reverse GLP-1 drug exposure in patients when cessation of therapy is needed or desired. Reversibility can be an important clinical consideration in certain situations including when a woman becomes pregnant or when patients undergoing surgery have an increased aspiration risk. Recent Business Highlights On August 6, 2026, Vivani announced full enrollment and successful initial dosing of all participants in its SLIM-1™ Phase 1 trial for NPM-139, a miniature, subdermal semaglutide implant designed to provide six- to twelve-months of continuous drug delivery utilizing its proprietary NanoPortal™ technology. The trial of 20 GLP-1 naïve participants in Australia includes low-doses of NPM-139 and Wegovy® to assess safety, tolerability, and pharmacokinetics. Changes in weight will be measured. Top-line data from SLIM-1 are expected in November 2026, which the Company anticipates will pave the way for initiation of a Phase 2 dose-ranging trial in 2027. On July 7, 2026, the Company announced the signing of an agreement with Novo Nordisk to enable Novo Nordisk to evaluate NPM-139, the Company’s semaglutide drug implant. NPM-139, which utilizes Vivani’s NanoPortal™ platform technology, is under development for chronic weight management. There are no exclusivity provisions for NPM-139 or Vivani’s proprietary NanoPortal technology associated with this agreement. Also in July 2026, Vivani announced that its wholly owned subsidiary Cortigent, Inc., a developer of brain-computer interface devices based on precision neurostimulation technology, entered into a definitive merger agreement with Nasdaq-listed ClearOne, Inc. The transaction, which is expected to close in the third quarter of 2026 subject to customary closing conditions, is designed to establish Cortigent as a separately listed public company, reduce Vivani's direct expenditures related to Cortigent, and enable the Vivani team to focus fully on advancing its portfolio of miniature, ultra long-acting drug implants. On June 26, 2026, the Company announced the appointment of August J. Moretti to its board of directors. Mr. Moretti joins the board with extensive operating and financial executive experience spanning all phases of company growth. Mr. Moretti served as CFO of 4D Molecular Therapeutics from 2019 until his retirement. Prior to this he held CFO positions at Assertio Therapeutics until its acquisition by Zydus Lifesciences; Alexza Pharmaceuticals until its acquisition by Ferrer Pharmaceuticals; and Alavita, Inc. Mr. Moretti holds a B.A. in Economics from Princeton University and a J.D. from Harvard Law School. On June 25, 2026, Vivani announced that it had received approval from Bellberry, a human research ethics committee (HREC) in Australia to initiate SLIM-1™, a Phase 1 clinical trial of NPM-139, a semaglutide implant. Upcoming Anticipated Milestones Completion of SLIM-1, the on-going Phase 1 study of low-dose NPM-139, Vivani’s miniature, ultra long-acting semaglutide implant under development for chronic weight management, and anticipated reporting of top-line results in November 2026. Preparation, and submission of an Investigational New Drug (“IND”) Application for NPM-139 to support initiation of a proposed Phase 2 dose-ranging study of this semaglutide implant planned for 2027. Transition of Cortigent into an independent, publicly traded company following completion of all customary closing and related financing activities. We anticipate establishment of the post-merger company, renamed Cortigent Holdings (d/b/a Cortigent), to be traded on the Nasdaq exchange under the ticker (CRGT) in the third quarter of 2026. Second Quarter 2026 Financial Results Cash: As of June 30, 2026, Vivani had cash, cash equivalents and restricted cash totaling $20.8 million, compared to $17.6 million as of December 31, 2025. The increase of $3.2 million is primarily attributed to tranche closings associated with share purchase agreements entered into in 2025 with an entity affiliated with one of our independent directors and a private placement and registered direct offering completed in January, 2026, offset by net loss for the six months ending June 30, 2026, of $13.2 million. Research and development expense, net of grants: Research and development expense, net of grants, during the three months ended June 30, 2026 was $4.5 million, compared to $4.8 million during the three months ended June 30, 2025. The decrease of $0.3 million, or 6%, was primarily attributable to the decrease in both the clinical trial related expense and development expense from our Biopharm Division. General and administrative expense, net of grants: General and administrative expense, net of grants, during the three months ended June 30, 2026 was $2.4 million, compared to $2.7 million during the three months ended June 30, 2025. The decrease of $0.3 million, or 11%, was primarily attributable to the decrease in the professional services from our Neurostimulation Division and our Biopharm Division. Other income, net: Other income, net during the three months ended June 30, 2026 was $0.5 million, compared to $0.3 million during the three months ended June 30, 2025. The increase of $0.2 million was primarily attributable to the derecognition of a contract liability previously held by the Neurostimulation Division, offset by lower interest income earned during the period. Net loss: For the foregoing reasons, we had a net loss of $6.4 million during the three months ended June 30, 2026 compared to $7.1 million during the three months ended June 30, 2025. About SLIM-1™ TrialSLIM-1 is an open-label, active-controlled trial evaluating a low-dose NPM-139 (semaglutide implant) given to 10 participants, and the starting dose of Wegovy (0.25mg/week semaglutide injection) is also given to 10 participants, over a four-week duration. The trial is designed to evaluate the safety, tolerability and pharmacokinetic profile in overweight or obese participants who are otherwise healthy. Top-line results from SLIM-1 are expected to be available in November. About Vivani Medical, Inc. Leveraging its proprietary NanoPortal™ platform, Vivani develops miniature, biopharmaceutical implants designed to deliver drug molecules steadily over extended periods of time with the goal of guaranteeing adherence and improving patient tolerance to their medication. Vivani is developing a portfolio of GLP-1 based implants for metabolic diseases including obesity and type 2 diabetes. These NanoPortal implants are designed for once- or twice-yearly administration to provide patients with the opportunity to realize the full potential benefit of their medication by avoiding the numerous challenges associated with the daily or weekly administration of orals and injectables, including tolerability issues and loss of efficacy. Medication non-adherence occurs when patients do not take their medication as prescribed. This affects an alarming number of patients, approximately 50%, including those taking daily pills. For more information, please visit: www.vivani.com. About Cortigent, Inc. Cortigent, Inc., a wholly owned subsidiary of Vivani, is developing brain implant devices to help patients recover critical body functions. Its patent-protected precision neurostimulation technology platform leverages neuroscience and proprietary microelectronics to create advanced medical devices. Vivani’s predecessor, Second Sight Medical Products, previously marketed Argus® II, the first and only medical device to obtain FDA approval to treat a rare form of blindness. This innovative device has helped hundreds of profoundly blind patients to achieve meaningful visual perception. Cortigent’s next generation investigational system, the Orion® cortical stimulation system, has been designed to treat blindness caused by common conditions including glaucoma and diabetic retinopathy. Orion has an FDA Breakthrough Device designation, completed a 6-year Early Feasibility Study in 2025 with promising safety and efficacy results and is covered by an extensive intellectual property estate. Cortigent is also applying its core technology to improving recovery of arm and hand motion in patients with paralysis due to stroke. For more information and patient videos, please visit: www.cortigent.com. Forward-Looking Statements This press release contains certain “forward-looking statements” within the meaning of the “safe harbor” provisions of the U.S. Private Securities Litigation Reform Act of 1995. Forward-looking statements can be identified by words such as: “target,” “believe,” “expect,” “will,” “may,” “anticipate,” “estimate,” “would,” “positioned,” “future,” and other similar expressions that are used in this press release, including statements regarding Vivani’s business, products in development, including the therapeutic potential or the planned development thereof, and its technology, strategy, cash position and financial runway. Forward-looking statements are neither historical facts nor assurances of future performance. Instead, they are based only on Vivani’s current beliefs, expectations, and assumptions. Because forward-looking statements relate to the future, they are subject to inherent uncertainties, risks and changes in circumstances that are difficult to predict and many of which are outside of Vivani’s control. These statements involve risks and uncertainties that could cause actual results to differ materially from those reflected in such statements, including, without limitation, risks of unexpected costs or delays, and risks and uncertainties associated with the development and commercialization of products and product candidates that may impact or alter anticipated business plans, strategies and objectives. Actual results and outcomes may differ materially from those indicated in the forward-looking statements. Therefore, you should not rely on any of these forward-looking statements. The foregoing sets forth many, but not all, of the factors that could cause actual results to differ from Vivani’s expectations in any forward-looking statement. There may be additional risks that the Company considers immaterial, or which are unknown. A further list and description of risks and uncertainties are more fully described in periodic filings with the U.S. Securities and Exchange Commission (the “SEC”) including the factors described in Vivani’s most recent Quarterly Report on Form 10-Q filed with the SEC on May 13, 2026, as updated by future filings with the SEC. Any forward-looking statement made by Vivani in this press release is based only on information currently available to the Company and speaks only as of the date of this press release. The Company undertakes no obligation to publicly update any forward-looking statement, whether written or oral, that may be made from time to time, whether as a result of added information, future developments or otherwise, except as required by law. Company Contact:Donald DwyerChief Business [email protected](415) 506-8462 Investor and Media Relations Contact:Jami TaylorInvestor and Media Relations [email protected](415) 506-8462

-- Phase 2b PLATEAU clinical trial of enobosarm and semaglutide combination for high quality weight loss is fully enrolled with 239 patients – -- Phase 2b PLATEAU clinical trial interim analysis and results on track for calendar Q1 2027-- -- In June 2026 Company announced a clinical supply agreement with Novo Nordisk for its Phase 2b PLATEAU clinical trial -- -- In August 2026 Company announced USPTO notice of allowance for key U.S. patent for enobosarm and semaglutide; when issued, U.S. patent protection until at least October 2044 -- -- Company to host conference call and webcast today at 8:00 a.m. ET – MIAMI, FL, Aug. 10, 2026 (GLOBE NEWSWIRE) -- Veru Inc. (NASDAQ: VERU), a late clinical stage biopharmaceutical company focused on developing innovative medicines for the treatment of cardiometabolic and inflammatory diseases, today announced financial results for its fiscal 2026 third quarter ended June 30, 2026, and provided an update on progress of its clinical development programs. “We are extremely pleased with the continued enobosarm progress during this past quarter,” said Mitchell Steiner, M.D., Chairman, President, and Chief Executive Officer of Veru Inc. “We reached full enrollment of the Phase 2b PLATEAU clinical trial and entered into a clinical supply agreement with Novo Nordisk for the Phase 2b PLATEAU clinical trial.* In addition, we received from the USPTO a notice of allowance for a key U.S. patent for enobosarm with semaglutide for high quality weight loss which when issued, will provide U.S. patent protection until at least October 2044.” Dr. Steiner added: “We believe these accomplishments mark important milestones in advancing enobosarm as a potential important combination therapy with GLP-1 receptor agonists. There is a significant unmet medical need to make weight reduction more tissue selective by maximizing fat loss while preserving lean mass, physical function, and bone mineral density for the highest quality weight reduction especially in older patients who have low muscle reserves and obesity. I want to thank both the patients and the investigators for their enthusiasm to expeditiously reach full enrollment for this very important study. We remain on track to achieve the near-term milestone of reporting the interim analysis results from the Phase 2b PLATEAU clinical trial in the first quarter of calendar year 2027.” Obesity ProgramEvaluating enobosarm in combination with GLP-1 RA for higher quality weight reduction in older patients with obesity Fully Enrolled Phase 2b PLATEAU Clinical StudyThe Phase 2b PLATEAU clinical trial is a double-blind, placebo-controlled study to evaluate the effect of enobosarm 3mg on total body weight, fat mass, lean mass, physical function, bone mineral density and safety in older patients (age ≥ 65 years) who have obesity (BMI ≥ 35) and are initiating semaglutide treatment for weight reduction. During the past quarter, the Company exceeded its Phase 2b PLATEAU clinical trial targeted full enrollment of 200 patients by enrolling 239 patients. The Phase 2b PLATEAU study is designed to assess the ability of enobosarm treatment to break through the weight loss plateau observed in patients with obesity receiving GLP-1 RA treatment by preserving muscle mass and physical function to achieve clinically meaningful incremental weight reduction by 68 weeks. The primary efficacy endpoint of the study is the percent change from baseline in total body weight at 68 weeks. The key secondary endpoints are total fat mass, total lean mass, physical function (stair climb test), mobility disability assessment, bone mineral density, and patient reported outcome questionnaires for physical function, HbA1c, and insulin resistance. Results of an interim analysis assessing lean body mass and fat mass as measured by DXA after patients have completed 32 weeks is expected in the first quarter of calendar year 2027. Final topline clinical data is expected in the fourth quarter of calendar year 2027. The Principal Investigator for the Phase 2b PLATEAU clinical trial is Steven Heymsfield, MD, a Professor and the Director of the Body Composition-Metabolism Laboratory at the Pennington Biomedical Research Center in Baton Rouge, Louisiana. Dr. Heymsfield was also the Principal Investigator of Veru’s Phase 2 QUALITY clinical study. Completed Positive Phase 2b QUALITY Clinical StudyThe Phase 2b QUALITY clinical study was a positive multicenter, double-blind, placebo-controlled, randomized, dose-finding clinical trial that evaluated the safety and efficacy of enobosarm 3 mg, enobosarm 6 mg, or placebo as a treatment to augment fat loss and to prevent muscle loss in 168 older patients (≥60 years of age) receiving semaglutide (Wegovy®**) for weight reduction. After the efficacy dose-finding portion of the Phase 2b QUALITY clinical trial was completed at 16 weeks, participants continued into a Phase 2b maintenance extension study where all patients discontinued semaglutide treatment, but continued receiving placebo, enobosarm 3 mg, or enobosarm 6 mg as monotherapy in a double-blind fashion for 12 weeks. The Phase 2b QUALITY and Maintenance Extension clinical trial was a positive study that demonstrated that enobosarm plus semaglutide preserved lean mass and physical function and led to greater fat loss during the 16 week active weight loss period and enobosarm monotherapy prevented the regain of weight lost when the GLP-1 RA was discontinued. Recent Developments Regarding Enobosarm Intellectual PropertyRecently the Company received from the United States Patent and Trademark Office (USPTO) a Notice of Allowance for U.S. Patent Application titled “Compositions Comprising Selective Androgen Receptor Modulator Compounds in Combination with Weight Loss Drugs and Uses Thereof for Quality Weight Loss.” The Notice of Allowance indicates that the USPTO has determined that the patent application meets the requirements for patentability and is expected to issue as a U.S. patent. The Notice of Allowance encompasses treatment regimens where: (i) enobosarm is concurrently given with semaglutide; (ii) enobosarm is added to initial semaglutide monotherapy with said co-therapy continuing; and (iii) enobosarm continues or is initiated as monotherapy after semaglutide therapy is discontinued. The allowed claims are directed to the: (i) preservation, restoration, or gaining of lean body mass; (ii) preservation, restoration, or gaining of muscle mass; (iii) enhancement of fat mass loss, including reducing abdominal, subcutaneous, or intramuscular fat accumulation, improving body composition, lowering body fat content, and lowering fat mass; (iv) preservation, restoration, or improvement of physical function and the corresponding prevention or treatment of a number of conditions that can result from decreased physical function such as reducing or treating muscle weakness, poor balance, decreased gait speed, mobility disability, loss of independence, increased risk of falls, loss of physical function, physical disability, poor quality of life, high hospitalization rates, and/or increased mortality; (v) preservation, restoration, or gaining of bone, and the corresponding prevention or treatment of bone fractures; (vi) overcoming or improving of insulin resistance; (vii) improving of HbA1c; (viii) reduction of or treatment to prevent total body weight gain rebound after discontinuing semaglutide; (ix) reduction of or treatment to prevent fat mass gain rebound after discontinuing semaglutide; and (x) treatment to prevent or restore lean mass loss during rebound after discontinuing semaglutide. When issued, this U.S. patent will have a patent expiry of at least October 3, 2044, prior to the potential application of any patent term adjustment or patent term extension. These allowed claims add to the Company’s growing intellectual property portfolio for enobosarm for quality weight loss, including already issued enobosarm specific polymorph composition of matter patents, as well as a number of other pending uses of selective androgen receptor modulator compounds alone or in combination with weight loss drugs for quality weight loss and chronic weight management patent applications.  In addition, the patent portfolio of Veru includes patent applications directed to a novel, oral, modified-release enobosarm formulation, which if such patent were to issue, would provide patent protection until at least May 2046. The Company owns a worldwide portfolio of patent applications directed to the methods of use of enobosarm in combination with weight loss drugs for higher quality weight loss and incremental weight loss. These claims encompass weight loss drugs including incretin containing drugs such as GLP-1 RA drugs. The Company continues to prosecute a number of pending patent applications worldwide covering a number of different weight loss drugs beyond semaglutide. Third Quarter Financial Summary: Fiscal 2026 vs Fiscal 2025 Research and development expenses increased to $4.4 million from $3.0 million General and administrative expenses decreased to $3.4 million from $5.0 million Operating loss from continuing operations increased to $7.7 million from $7.5 million Net loss decreased to $7.0 million, or $0.30 per share, compared to $7.3 million, or $0.50 per share Year-to-Date Financial Summary: Fiscal 2026 vs Fiscal 2025 Research and development expenses decreased to $8.8 million from $12.7 million General and administrative expenses decreased to $11.5 million from $15.4 million Operating loss from continuing operations decreased to $20.4 million from $25.9 million Net loss decreased to $15.1 million, or $0.68 per share, compared to $24.2 million, or $1.65 per share Balance Sheet Information ​​​​​Cash, cash equivalents and restricted cash were $23.9 million as of June 30, 2026 versus $15.8 million as of September 30, 2025 Event DetailsThe audio webcast will be accessible under the Home page and Investors page of the Company’s website at www.verupharma.com. To join the conference call via telephone, please dial 1-800-341-1602 (domestic) or 1-412-902-6706 (international) and ask to join the Veru Inc. call. An archived version of the audio webcast will be available for replay on the Company’s website for approximately three months. A telephonic replay will be available at approximately 12:00 p.m. ET by dialing 1-855-669-9658 (domestic) or 1-412-317-0088 (international), passcode 2565519, for one week. About Veru Inc.Veru is a late clinical stage biopharmaceutical company focused on developing innovative medicines for the treatment of cardiometabolic and inflammatory diseases. The Company’s drug development program includes two late-stage novel small molecules, enobosarm and sabizabulin. Enobosarm, an oral selective androgen receptor modulator (SARM), is being developed as a next generation drug that makes weight reduction by GLP-1 RA drugs more tissue selective for loss of fat and preservation of lean mass to improve body composition and physical function which is expected to result in clinically meaningful incremental weight reduction versus GLP-1 RA therapy alone. Sabizabulin, a microtubule disruptor, is being developed for the treatment of chronic inflammation related to atherosclerotic cardiovascular disease. Forward-Looking StatementsThis press release contains "forward-looking statements" as that term is defined in the Private Securities Litigation Reform Act of 1995, including, without limitation, express or implied statements related to the planned design, enrollment, timing, commencement, interim, topline and full data readout timing, scope and regulatory pathways for the continued development of enobosarm in patients with obesity, including the PLATEAU Phase 2b study; express or implied statements related to the issuance and scope of coverage, including allowed claims and treatment regimens, of a method of use patent from the Notice of Allowance for US Patent Application titled “Compositions Comprising Selective Androgen Receptor Modulator Compounds in Combination with Weight Loss Drugs and Uses Thereof for Quality Weight Loss”, as well as other pending methods of use and formulation patents; whether the patent application meets requirements of patentability and, if and when the patent is issued, will provide patent protection until at least October 2044; whether new indications will be discovered or granted and whether the allowed claims under said Notice of Allowance, if and when issued, will add additional coverage and protection to new indications and the Company’s growing intellectual property portfolio for enobosarm for quality weight loss, and other pending uses of selective androgen receptor modulator compounds alone or in combination with weight loss drugs; whether the pending patent applications will be approved for claims that encompass a novel, oral, modified-release enobosarm formulation and if issued, will provide patent protection until at least May 2046; the planned design, number of sites, timing, endpoints, patient population and patient size of such trial and whether the PLATEAU trial will successfully meet any of its primary or secondary endpoints; whether the results of the Phase 2b QUALITY study and the extension maintenance study of enobosarm, including weight loss, preservation of lean mass and physical function and loss of fat mass and the prevention of the regain of fat mass and total body weight loss, will be replicated to the same or any degree in the PLATEAU Phase 2b study or in any future Phase 3 studies; whether and when the PLATEAU Phase 2b study of enobosarm will produce an interim analysis and/or topline data; whether enobosarm in combination with a GLP-1 RA drug will provide a higher quality and/or greater quantity weight loss in patients and whether enobosarm will be the next generation combination therapy with GLP-1 receptor agonists for older patients with obesity that makes weight reduction more tissue selective for loss of fat, preservation of lean mass, physical function, improved body composition and maintaining or increasing bone mineral density, and demonstrating favorable HbA1c and insulin resistance results, all while maintaining a favorable safety profile; whether patients treated with enobosarm in the PLATEAU Phase 2B study will break through the weight loss plateau and achieve clinically meaningful incremental weight reduction by preserving muscle mass and physical function whether enobosarm will enhance or achieve a higher quality weight loss or the preservation of muscle in, or meet any unmet need for, obesity patients, including whether it will provide important insights into quality weight loss therapy and the design of a Phase 3 clinical development program; and whether the Company will be successful in its transformation into a late stage biopharmaceutical company focused on obesity and inflammatory disease. The words "anticipate," "believe," "could," "expect," "intend," "may," "opportunity," "plan," "predict," "potential," "estimate," "should," "will," "would" and similar expressions are intended to identify forward-looking statements, although not all forward-looking statements contain these identifying words. Any forward-looking statements in this press release are based upon current plans and strategies of the Company and reflect the Company's current assessment of the risks and uncertainties related to its business and are made as of the date of this press release. The Company assumes no obligation to update any forward-looking statements contained in this press release because of new information or future events, developments, or circumstances. Such forward-looking statements are subject to known and unknown risks, uncertainties and assumptions, and if any such risks or uncertainties materialize or if any of the assumptions prove incorrect, our actual results could differ materially from those expressed or implied by such statements. Factors that may cause actual results to differ materially from those contemplated by such forward-looking statements include, but are not limited to: the development of the Company’s product portfolio and the results of clinical studies, including any interim or topline analysis, possibly being unsuccessful or insufficient to meet applicable regulatory standards or warrant continued development; although the Company has sought and received feedback from the FDA on the designs of its clinical trials and intends to continue to do so, the FDA may ultimately disagree that the Company’s clinical trials support approval; the Company’s ability to reach agreement with FDA on study design requirements for the Company’s planned clinical studies, including for the Phase 2b program for enobosarm as a weight loss or body composition drug and the number of future Phase 3 studies to be required and the cost thereof; potential delays in the timing of and results from clinical trials and studies, including as a result of an inability to enroll sufficient numbers of patients in clinical studies or an inability to enroll patients in accordance with planned schedules; the ability to fund planned clinical development as well as other operations of the Company; the Company plans to prioritize the use of its current internal cash to the development of enobosarm, with a primary near-term focus on funding its PLATEAU Phase 2b clinical trial, and as a result advancement of sabizabulin as a treatment for slowing progression of or promoting regression of atherosclerosis disease will depend upon the Company securing additional funding; whether the Company will be able to partner with another company in the development of enobosarm or sabizabulin; the timing of any submission to the FDA or any other regulatory authority and any determinations made by the FDA or any other regulatory authority; the potential for disruptions at the FDA or other government agencies to negatively affect our business, including as a result of a future shutdown of the U.S. government; any products of the Company, if approved, possibly not being commercially successful; the risk that the Supply Agreement with Novo Nordisk could be terminated prior to the completion of the Company’s PLATEAU Phase 2b clinical trial, including pursuant to a provision that permits Novo Nordisk to terminate for convenience upon 60 days’ prior notice; the ability of the Company to obtain sufficient financing, including any partnership or collaboration agreements, on acceptable terms when needed to fund development and operations and to enable us to continue as a going concern; the effect of the SEC’s “baby shelf” rules on the Company’s ability to raise sufficient capital when needed; demand for, market acceptance of, and competition against any of the Company’s products or product candidates; new or existing competitors with greater resources and capabilities and new competitive product approvals and/or introductions; changes in regulatory practices or policies or government-driven healthcare reform efforts, including pricing pressures and insurance coverage and reimbursement changes; the Company’s ability to obtain, protect and enforce its data, intellectual property and other proprietary rights; costs and other effects of litigation, including regulatory challenges, product liability claims, intellectual property claims and challenges, securities litigation and litigation with the purchaser of the Company’s FC2 business; the Company’s ability to identify, successfully negotiate and complete suitable acquisitions or other strategic initiatives; the Company’s ability to successfully integrate acquired businesses, technologies or products; and other risks detailed from time to time in the Company’s press releases, shareholder communications and Securities and Exchange Commission filings, including the Company's Form 10-K for the year ended September 30, 2025, and subsequent quarterly reports on Form 10-Q. These documents are available on the “SEC Filings” section of our website at www.verupharma.com/investors. *During the past quarter the Company announced a clinical supply agreement with Novo Nordisk for its Phase 2b PLATEAU clinical study. Please see the Company’s SEC Form 8-K dated June 2, 2026 for further details. **Wegovy® is a registered trademark of Novo Nordisk A/S. FINANCIAL SCHEDULES FOLLOW Investor and Media Contact: Samuel FischExecutive Director, Investor Relations and Corporate CommunicationsEmail: [email protected]

Pfizer PFE stock has risen 6.9% since it announced second-quarter 2026 results on Aug. 4. Pfizer delivered a solid second quarter, beating estimates for both earnings and revenues. While earnings growth was flat year over year, revenues rose 1% on an operational basis. Strength in non-COVID products continued to offset declining sales of its COVID products, Comirnaty (COVID-19 vaccine - in partnership with BioNTech [BNTX]) and Paxlovid (oral antiviral). Excluding sales from BioNTech-partnered Comirnaty and Paxlovid, revenues increased 5% operationally. Pfizer also raised the lower end of its 2026 revenue guidance, backed by continued strong performance of its new and acquired products. The company now expects revenues between $60.5 billion and $62.5 billion, compared with the previous range of $59.5 billion to $62.5 billion. The adjusted earnings guidance was reaffirmed at $2.80-$3.00 per share. However, the guidance now absorbs a 10 cents per share charge related to its licensing deal with Chinese biotech Innovent Biologics that will be recorded in the third quarter of 2026. However, a single quarter’s results are not so important for long-term investors. To make an informed decision on whether to buy, sell or hold the stock, it is important to evaluate the company’s fundamentals by examining its key strengths and weaknesses. First, let’s understand the negatives. During the pandemic, Pfizer generated extraordinary COVID-related sales from Comirnaty and Paxlovid. Those revenues have fallen sharply as the pandemic faded. Sales of Pfizer’s COVID products, Comirnaty and Paxlovid, came down to around $11 billion in 2024 and $6.7 billion in 2025 from $56.7 billion in 2022. Sales of Comirnaty are declining due to a narrow recommendation for COVID vaccines in the United States, while Paxlovid is experiencing reduced demand from lower infection rates. In 2026, Pfizer expects COVID-related revenues of approximately $4 billion, down from its previous forecast of $5 billion and below $6.7 billion generated in 2025. The decline reflects the continued normalization of COVID-19 infection rates and lower demand for COVID products. Consistent with this trend, sales of both Comirnaty and Paxlovid declined significantly during the first half of 2026. Pfizer faces a significant patent cliff later this decade. Pfizer expects a significant negative impact on revenues from the loss of exclusivity (“LOE”) cliff in the 2026-2030 period as several of its key products, including Eliquis, Ibrance, Xeljanz and Xtandi, face patent expirations. The LOE cliff is expected to hurt sales by approximately $1.1 billion in 2026, which is slightly lower than the prior expectation of $1.5 billion. Pfizer’s revenue and earnings guidance for 2026 indicates mostly flat to slightly negative year-over-year growth. Pfizer expects total revenues for 2026 to be between $60.5 billion and $62.5 billion. The range represents a slight decline from 2025 revenues of $62.6 billion due to lower revenues from COVID products, Comirnaty and Paxlovid, and loss of revenues from the upcoming patent cliff. In 2026, Pfizer expects adjusted earnings per share in the range of $2.80-$3.00, which represents a decline from the 2025 EPS of $3.22 due to the dilutive impact of 3SBio and Metsera deals, lower COVID revenues and higher taxes. However, not everything is going wrong at Pfizer. Let’s see the positives. Pfizer's business mix has changed significantly over the past few years. During the pandemic, the company became heavily dependent on COVID-19 products.  However, the company is gradually diversifying its portfolio through a combination of internal product launches like Abrysvo, Zavzpret, Elrexfio, Hympavzi, Litfulo and others, strategic acquisitions like Seagen, Metsera and Biohaven and the continued growth of several established brands like Vyndaqel, Padcev and Eliquis. Pfizer expects its recently launched and acquired products to record continued double-digit growth. Reflecting this trend, sales from these products increased 22% operationally in the first quarter of 2026 and 18% in the second quarter. Pfizer is one of the world’s leading oncology drugmakers with a broad portfolio of marketed cancer therapies as well as a deep oncology pipeline spanning multiple treatment modalities, including small molecules, antibody-drug conjugates (ADCs) and immuno-oncology biologics. Oncology sales comprise around 27% of its total revenues. Its oncology revenues grew 5% in the first half of 2026, driven by drugs like Xtandi, Lorbrena, the Braftovi-Mektovi combination and Padcev. Pfizer considers Padcev to be a potential growth driver in the oncology segment and plans to invest in this asset. Pfizer has ventured into the oncology biosimilars space and markets six biosimilars for cancer. It is also advancing its oncology clinical pipeline across areas such as breast, thoracic, gastrointestinal and blood cancers. Several oncology candidates have entered late-stage development, such as atirmociclib and sigvotatug vedotin. A regulatory application seeking approval of sasanlimab is also under review in the EU. A key candidate in its oncology pipeline is PF-08634404, a dual PD-1/VEGF inhibitor in-licensed from Chinese biotech 3SBio in 2025. Pfizer has initiated nine studies, including two pivotal phase III studies for PF-08634404 in first-line metastatic colorectal cancer and first-line NSCLC. Pfizer aims to establish PF-08634404 as a potential backbone therapy across multiple tumor types. By 2030, Pfizer expects to have eight or more blockbuster oncology medicines in its portfolio. The company is rebuilding its pipeline in oncology and obesity, which it believes can drive growth in 2028 and beyond. Pfizer plans an extensive phase III program for berobenatide, its monthly GLP-1 receptor agonist added from last year’s Metsera acquisition, in 2026. Pfizer plans to start more than 20 obesity studies in 2026, including 10 phase III studies for berobenatide for obesity and obesity-related comorbidities, including knee osteoarthritis and obstructive sleep apnea. Three phase III studies on berobenatide have already begun. Pfizer is targeting the first of a series of potential approvals for berobenatide in 2028. Pfizer is also evaluating berobenatide in combination with an amylin-based therapy, PF'3945, in phase II studies. However, in the obesity space, Pfizer lags far behind leaders like Eli Lilly LLY and Novo Nordisk NVO. Pfizer’s stock has risen 7.5% so far this year compared with an increase of 11.4% for the industry. Image Source: Zacks Investment Research From a valuation standpoint, Pfizer appears attractive relative to the industry and is trading below its five-year mean. Going by the price/earnings ratio, Pfizer’s shares currently trade at 9.08 forward earnings, significantly lower than 18.53 for the industry and slightly lower than the stock’s five-year mean of 9.28. The stock is also trading below most large drugmakers like Lilly, Novo Nordisk, AstraZeneca, AbbVie, J&J and others. Image Source: Zacks Investment Research The Zacks Consensus Estimate for 2026 earnings is stable at $2.97 per share, while that for 2027 has risen from $2.86 per share to $2.93 per share over the past 30 days. Image Source: Zacks Investment Research Pfizer is navigating a difficult transition following the sharp decline in COVID-related sales from Comirnaty and Paxlovid. The market is concerned about Pfizer’s ability to replace declining COVID-related revenues and offset upcoming patent expirations through new product launches, pipeline development and contributions from acquisitions. Although Pfizer’s 2026 sales guidance indicates minimal growth, the company expects a high single-digit revenue CAGR for five years, starting from year-end 2028. Pfizer expects its recently launched and acquired products, along with a strong pipeline, to help it return to growth from 2029 onward. Pfizer's valuation is relatively inexpensive compared with many large pharmaceutical peers, and the stock offers one of the highest dividend yields in the sector. Pfizer’s dividend yield stands at around 6.4% Pfizer’s significant cost reduction and efforts to improve R&D productivity measures are also driving profit growth. Pfizer expects approximately $9.7 billion in total net savings from its productivity enhancement initiative through 2029. Long-term investors may consider retaining this Zacks Rank #3 (Hold) stock and can wait and see if Pfizer can successfully execute on its strategy and generate meaningful growth from its newer assets and restore revenue growth. 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 Pfizer Inc. (PFE) : Free Stock Analysis Report Novo Nordisk A/S (NVO) : Free Stock Analysis Report Eli Lilly and Company (LLY) : Free Stock Analysis Report BioNTech SE Sponsored ADR (BNTX) : Free Stock Analysis Report This article originally published on Zacks Investment Research (zacks.com). Zacks Investment Research

Interested in Novo Nordisk A/S? Here are five stocks we like better. Novo Nordisk raised its 2026 outlook after a better-than-expected start to the year, reporting Q2 adjusted sales of DKK 78.5 billion and 7% growth at constant exchange rates. However, lower realized prices, manufacturing costs and currency effects reduced the adjusted gross margin to 78.2% from 82.7%. Oral Wegovy drove obesity-treatment momentum. The U.S. pill surpassed 5 million prescriptions and captured about 90% of the oral obesity-drug market, while roughly 80% of users were new to GLP-1 treatments; international obesity sales rose 37%. Competition and pipeline risks remain. Novo expects U.S. sales declines, greater pricing pressure, reduced Medicaid coverage and rising generic competition, while the ZEUS cardiovascular trial of ziltivekimab failed to reduce major adverse cardiovascular events; CagriSema remains on track for a potential U.S. launch in 2027. The FTC Is Suing Hims & Hers Health—Here's Why Investors Shouldn't Panic Novo Nordisk A/S (NYSE:NVO) reported second-quarter adjusted sales growth of 7% at constant exchange rates, supported by GLP-1 volume growth across its obesity and diabetes franchises, while lower realized prices and manufacturing-related costs weighed on margins. Chief Executive Officer Mike Doustdar said the company is serving more than 46 million people with obesity and diabetes and is treating nearly 5 million people with its obesity therapies, about 70% more than a year earlier. Novo Nordisk also raised its full-year outlook following what Chief Financial Officer Karsten Munk Knudsen described as a better-than-expected start to 2026. → Sandisk Just Delivered a Blowout Quarter—Here's Why the Stock Is Falling Bearish Pressure Is Building Around These 3 Stocks The company highlighted continued momentum for its oral Wegovy treatment, which launched in the U.S. six months ago. Jamey Millar, executive vice president of U.S. Operations, said Wegovy pill had exceeded 5 million total prescriptions and reached weekly prescriptions of 267,000 as of July 17. Millar said the product has captured about 90% of the U.S. oral obesity-medication market despite competition entering in early April. Roughly 80% of patients using Wegovy pill are new to GLP-1 treatment, according to the company, suggesting the therapy is expanding the market rather than solely switching patients from existing products. → 4 Oil and Gas ETF Plays as Prices Stay Sky-High As Employers Drop Obesity Drug Coverage, Hims & Hers Could Be the Winner Most U.S. Wegovy pill prescriptions remain self-pay, as access to reimbursed obesity GLP-1 treatments remains limited. Novo Nordisk is also pursuing broader access through its Medicare Part D Bridge program for eligible patients age 65 and older. Millar said early participation has been encouraging, though the company is still assessing whether the initial uptake will be durable. The broader branded obesity-medication market grew volumes by about 70% from the second quarter of 2025, Novo Nordisk said. The Wegovy franchise held an approximately 60% share of new branded obesity prescriptions in July. → No Hangover: Revisiting Microsoft One Week After Earnings Outside the U.S., International Operations GLP-1 sales rose 13%, with obesity franchise sales increasing 37%. Emil Kongshøj Larsen, executive vice president of International Operations, said Novo Nordisk held about 58% of GLP-1 volume market share outside the U.S., though its share has declined in recent quarters. The company launched Wegovy pill in the U.K. and United Arab Emirates during the quarter. In the U.K., Novo Nordisk estimated that about 300,000 patients started treatment within three weeks of broad availability in early July. The company said this initial uptake raised its overall obesity market share in the country from about 30% before launch to 45%, based on July IQVIA sell-in data to private providers and pharmacies. Germany is expected to be the next launch market, beginning in September. Second-quarter adjusted sales totaled DKK 78.5 billion. U.S. Operations grew 4%, while International Operations increased 10%. Obesity care sales rose 16%, supported by volume growth across the Wegovy portfolio, while GLP-1 diabetes sales increased 2%. Adjusted gross margin fell to 78.2% from 82.7% a year earlier. Knudsen attributed the decline to lower realized prices, a roughly DKK 3 billion one-time cost related to resizing manufacturing-capacity agreements, and negative currency effects. Productivity gains and a more favorable mix from GLP-1 sales partly offset those factors. Adjusted operating profit increased 11% at constant exchange rates. The company said it is ahead of plan on its DKK 8 billion cost-savings program, with the savings being reinvested in research, development and commercial growth initiatives. Novo Nordisk ended the quarter with approximately 66,700 full-time employees, down nearly 12,000 employees, or roughly 15%, from a year earlier. In the U.S., Wegovy injectable sales faced pricing pressure despite volume growth. Knudsen said self-pay patients now account for about 35% of U.S. injectable Wegovy sales, compared with roughly 10% to 15% a year ago. The self-pay channel carries a different price point but has helped expand patient access, he said. Novo Nordisk raised its 2026 outlook and now expects adjusted sales growth and adjusted operating-profit growth of between 0% and negative 6% at constant exchange rates. Knudsen said the outlook improvement primarily reflects stronger expectations for GLP-1 sales. However, the forecast assumes sales growth internationally and a sales decline in the U.S. It also incorporates intensifying U.S. competition, reduced Medicaid coverage for obesity medications, lower realized prices associated with market-access investments, and effects from most-favored-nation agreements with the U.S. administration. The company also expects the loss of semaglutide exclusivity in markets including Canada and Brazil to have a greater effect in the second half, with that impact annualizing into 2027. Novo Nordisk said generic competition in early loss-of-exclusivity markets has been modest so far but is expected to be more significant later in the year. On the research front, Novo Nordisk disclosed that its ZEUS cardiovascular outcomes trial of ziltivekimab did not meet its primary objective. The study enrolled more than 6,300 patients with established cardiovascular disease, chronic kidney disease and inflammation. Martin Holst Lange, executive vice president of R&D and chief scientific officer, said ziltivekimab demonstrated target engagement and reduced inflammatory biomarkers, but this did not translate into lower major adverse cardiovascular events. The hazard ratio for major adverse cardiovascular events was 0.99. Overall adverse-event rates were similar to placebo, though serious infections occurred more frequently with ziltivekimab. The company said the result does not alter its commitment to cardiovascular disease research. Two additional ziltivekimab outcomes trials, ARTEMIS in acute myocardial infarction and HERMES in heart failure with preserved ejection fraction, are continuing, with results expected in the first half of 2027. Novo Nordisk also completed its REDEFINE 9 trial of lower maintenance doses of CagriSema, reporting superior weight loss versus placebo and a safety and tolerability profile consistent with previous CagriSema studies. Detailed data are expected later this year. The company continues to expect a U.S. regulatory decision for CagriSema in obesity near the end of 2026, with a potential launch in 2027. Novo Nordisk A/S is a Danish multinational pharmaceutical company headquartered in Bagsværd, Denmark, best known for its leadership in diabetes care and metabolic health. The company traces its roots to early Danish insulin production in the 1920s and was established in its current form through a 1989 merger of predecessor companies. Novo Nordisk develops, manufactures and markets pharmaceutical products and devices that address chronic and serious diseases, with a strong emphasis on long-term treatment and patient support. The company’s core product portfolio centers on diabetes therapies, including a range of insulins and modern incretin-based treatments. This instant news alert was generated by narrative science technology and financial data from MarketBeat in order to provide readers with the fastest reporting and unbiased coverage. Please send any questions or comments about this story to [email protected]. The article "Novo Nordisk A/S Q2 Earnings Call Highlights" was originally published by MarketBeat. View MarketBeat's top stocks for August 2026.

Novo Nordisk A/S NVO used its second-quarter 2026 earnings call to emphasize stronger GLP-1 momentum, led by Wegovy pill, while highlighting pricing pressure, patent expirations and competition. The company raised its full-year outlook after adjusted sales and operating profit grew 7% and 11%, respectively, at constant exchange rates. Earnings of $0.96 per share topped the Zacks Consensus Estimate of $0.82. Revenues of $12.21 billion exceeded the $11.27 billion consensus mark. Novo Nordisk A/S price-consensus-eps-surprise-chart | Novo Nordisk A/S Quote CFO Karsten Knudsen raised 2026 adjusted sales and operating profit growth guidance to 0% to down 6% at constant exchange rates, from down 4% to down 12%. Knudsen said the improved view reflects higher GLP-1 sales expectations. International Operations should grow, while U.S. Operations should decline amid lower realized prices, reduced Medicaid obesity coverage and intensifying competition. In response to a Goldman Sachs analyst, Knudsen said second-half comparisons include semaglutide loss of exclusivity in Canada and Brazil and DKK 5 billion of favorable prior-year gross-to-net effects. The patent impact will annualize into 2027. Jamey Millar, EVP of U.S. Operations, said Wegovy pill exceeded 5 million total prescriptions, with weekly prescriptions reaching 267,000 as of July 17. The product held about 90% of the oral obesity market. Millar said roughly 80% of users were new to GLP-1 therapy, while cannibalization of injectable Wegovy remained limited. Most prescriptions were self-pay, highlighting access constraints in reimbursed channels. The Wegovy franchise held about 60% of branded obesity new-patient starts in July. Millar reported encouraging participation in the Medicare Part D Bridge program while noting that durability must be monitored. Emil Larsen, EVP of International Operations, said about 300,000 U.K. patients started Wegovy pill within three weeks. Novo Nordisk’s obesity market share there rose from about 30% before launch to 45%. Larsen attributed the response to pent-up demand and the injection barrier. In the UAE, Wegovy pill captured about 50% of the oral segment despite entering after a competitor. A Goldman Sachs analyst asked about Germany, where launch is planned for September. Larsen said telehealth represents one-third of that market and more than half of its growth, supporting similar tactics. Martin Lange, EVP of R&D and chief scientific officer, said the ZEUS trial failed to reduce major cardiovascular events despite IL-6 engagement. The hazard ratio was 0.99, and serious infections were higher with ziltivekimab. Lange said ARTEMIS and HERMES will continue, with results expected in the first half of 2027. He defended ongoing NLRP3 work, saying ZEUS did not settle the broader inflammation question. On CagriSema, Lange said REIMAGINE 4 achieved non-inferiority to tirzepatide for weight reduction but not A1c reduction. A U.S. obesity decision remains expected at year-end, with a potential 2027 launch. A Danske Bank analyst pressed management on the 22% constant-currency decline in U.S. injectable Wegovy sales. Millar said volume grew, but lower realized prices matched expectations and did not reflect a new pricing dynamic. Knudsen said self-pay represented about 35% of U.S. injectable Wegovy volume, versus 10% to 15% a year earlier. Adjusted gross margin fell to 78.2% from 82.7%, reflecting pricing, currency and capacity costs. In response to JPMorgan, Knudsen said the first product had been validated in the first production unit of a new API facility, while utilization was very low. He said unused capacity supports future international Wegovy pill supply. CEO Mike Doustdar described 2026 as challenging but said first-half progress exceeded the company’s starting expectations. Management remains focused on commercial competitiveness, pipeline progress and reinvestment. Knudsen said Novo Nordisk is ahead of plan on DKK 8 billion of transformation savings. Headcount fell by almost 12,000 year over year, creating room to fund growth priorities. NVO carries a Zacks Rank #5 (Strong Sell), with a Value Score of B, Growth Score of D, Momentum Score of A and VGM Score of B. The scores show favorable value, momentum and combined characteristics, but weaker growth attributes. Under the Zacks framework, Style Scores complement rather than override the Rank, so favorable A or B grades do not offset a #5 designation. The Zacks Rank can change as analysts revise estimates following the reported results. 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 Novo Nordisk A/S (NVO) : Free Stock Analysis Report This article originally published on Zacks Investment Research (zacks.com). Zacks Investment Research

Apitegromab Biologics License Application (BLA) for spinal muscular atrophy (SMA) review by FDA continues to advance with two fill-finish facilities, representing two independent paths to an FDA approval decision by September 30, 2026 Prescription Drug User Fee Act (PDUFA) date FDA review of second fill-finish facility progressing; Data package for FDA review of second fill-finish facility has been submitted; Ample supply available for commercialization upon FDA approval Scholar Rock is prepared for U.S. apitegromab launch immediately upon FDA approval, which may be granted at any time through September 30, 2026 Company engaging with European Medicines Agency (EMA) on next steps for apitegromab Marketing Authorisation Application (MAA); FDA inspection classification of Catalent Indiana LLC (part of Novo Nordisk) is pending Initiated Phase 2 FORGE study evaluating apitegromab in patients with facioscapulohumeral muscular dystrophy (FSHD) Cash, cash equivalents, and marketable securities of $492 million as of June 30, 2026; Includes $63 million in net cash proceeds from Company’s at-the-market (ATM) program Management to host a conference call today at 8:00 a.m. ET CAMBRIDGE, Mass., August 06, 2026--(BUSINESS WIRE)--Scholar Rock (NASDAQ: SRRK), a global biopharmaceutical company dedicated to improving the lives of patients with rare, severe, and debilitating neuromuscular diseases by applying its leading platform in myostatin biology, today reported financial results for the second quarter ended June 30, 2026, and provided an update on recent company developments. "We are on the threshold of securing the world’s first ever regulatory approval of a myostatin inhibitor, which will also be the first ever muscle-targeted treatment for children and adults living with SMA," said David L. Hallal, Board Chair and Chief Executive Officer of Scholar Rock. "Backed by a strong balance sheet, our Scholar Rock team is ready to usher in the next phase of innovation for the SMA community in the U.S. immediately upon apitegromab approval." Business Highlights and Upcoming Milestones Apitegromab Apitegromab is an investigational fully human monoclonal antibody designed to inhibit myostatin activation by selectively binding the pro- and latent forms of myostatin in skeletal muscle. It is the first and only muscle-targeted therapeutic candidate in SMA to demonstrate a statistically significant and clinically meaningful benefit in a pivotal Phase 3 clinical trial (SAPPHIRE). SMA Program Apitegromab Biologics License Application (BLA) on track for potential FDA approval by September 30, 2026 Prescription Drug User Fee Act (PDUFA) date. The FDA review of the apitegromab BLA is advancing with both the Catalent Indiana fill-finish facility and a second fill-finish facility, representing two independent paths to an FDA approval decision. At the March 2026 Type C meeting, FDA and Scholar Rock agreed to the data package required for FDA review of the second fill-finish facility. That data package has been submitted, and Agency review of the data is progressing well. Ample supply from the second fill-finish facility is available for commercialization upon FDA approval. The FDA inspection classification of Catalent Indiana following an April 2026 general site inspection is pending. U.S. Commercial team prepared to launch apitegromab upon FDA approval. The U.S. Commercial team remains active in the field with SMA prescribers and centers of excellence nationwide, furthering disease education and awareness initiatives. The Company had a significant presence at Cure SMA’s Annual SMA Conference and Annual SMA Research & Clinical Care Meeting, which was held June 23 – 28, 2026 in Orlando, FL. Scholar Rock engaging with European Medicines Agency (EMA) on next steps for apitegromab Marketing Authorisation Application (MAA). The EMA is reviewing the apitegromab MAA, which includes the Catalent Indiana fill-finish facility, and is awaiting the FDA inspection classification of Catalent Indiana. In parallel, Scholar Rock is engaging with the EMA on next steps, including the potential to add the Company’s second fill-finish facility to the MAA. The Company plans to provide updated guidance on timelines for a Committee for Medicinal Products for Human Use (CHMP) opinion upon alignment with the EMA. Continued robust enrollment in Phase 2 OPAL trial. Enrollment and dosing in the Phase 2 OPAL study is ongoing (NCT07047144). The OPAL study is evaluating apitegromab in infants and toddlers with SMA under two years of age who have received an approved SMN1-targeted gene therapy or who are receiving ongoing treatment with an approved SMN2-targeted therapy. Subcutaneous apitegromab progressing. Scholar Rock has developed a high concentration subcutaneous formulation of apitegromab. The Company plans to engage with the FDA and EMA to align on the development path following the regulatory approvals of apitegromab for SMA. Facioscapulohumeral Muscular Dystrophy (FSHD) Program Phase 2 FORGE trial initiated. The Phase 2 randomized, double-blind, placebo-controlled trial, called FORGE, is expected to enroll approximately 60 patients with FSHD who will be randomized 1:1 to receive either apitegromab 10mg/kg IV or placebo every 4 weeks for 52 weeks. The primary endpoint is mean lean muscle volume (LMV) change from baseline at 12 months. Secondary endpoints include safety, pharmacokinetics/pharmacodynamics, and mean LMV change from baseline at 6 months. Several exploratory functional endpoints will also be assessed. SRK-439 SRK-439 is a novel, investigational, subcutaneously administered myostatin inhibitor that binds to pro- and latent myostatin with high affinity and selectivity. Based on preclinical data, SRK-439 has the potential to potently inhibit myostatin and increase muscle mass. Phase 1 study in healthy volunteers ongoing. A Phase 1 study evaluating SRK-439 in healthy volunteers is progressing well with topline data anticipated in late 2026. Second Quarter 2026 Financial Results Scholar Rock reported a net loss of $109.9 million, including stock-based compensation of $19.7 million, for the quarter ended June 30, 2026, compared to a net loss of $110.0 million, including stock-based compensation of $24.4 million, for the quarter ended June 30, 2025. Net loss per common share was $0.84 for the quarter ended June 30, 2026, compared to $0.98 per common share for the quarter ended June 30, 2025. The Company did not record any revenue for the quarters ended June 30, 2026 and 2025. Research and development expense was $58.2 million, including $7.5 million in stock-based compensation, for the quarter ended June 30, 2026, compared to $62.4 million, including $5.8 million in stock-based compensation, for the quarter ended June 30, 2025. General and administrative expense was $50.7 million, including $12.2 million in stock-based compensation, for the quarter ended June 30, 2026, compared to $49.7 million, including $18.6 million in stock-based compensation, for the quarter ended June 30, 2025. As of June 30, 2026, Scholar Rock had cash, cash equivalents, and marketable securities of $492.1 million. This reflects net cash proceeds of $62.8 million from the Company’s at-the-market (ATM) program during the quarter ended June 30, 2026. Conference Call Information Scholar Rock will host a conference call and webcast today, Thursday, August 6, at 8:00 a.m. ET to review its second quarter 2026 financial results and discuss recent business updates. To access the live audio webcast, please go to "Events and Presentations" in the Investors section of the Scholar Rock website at http://investors.scholarrock.com. To participate via telephone, please register in advance here. Upon registration, all telephone participants will receive a confirmation email detailing how to join the conference call. A replay of the webcast will be available on the Company’s website for approximately 90 days. About Scholar Rock Scholar Rock is a late-stage biopharmaceutical company focused on developing and commercializing apitegromab for children and adults with spinal muscular atrophy (SMA) and other rare, severe and debilitating neuromuscular diseases. As a global leader in myostatin biology, a field focused on proteins that regulate muscle mass, the biopharmaceutical company is named for the visual resemblance of a scholar rock to protein structures. Our commitment to unlock fundamentally different treatment approaches is powered by broad application of a proprietary platform, which has developed novel monoclonal antibodies to modulate protein growth factors with extraordinary selectivity. Scholar Rock works every day to create new possibilities for patients through its highly innovative anti-myostatin programs, including opportunities in additional rare neuromuscular diseases. Learn more at ScholarRock.com and follow @ScholarRock on X and on LinkedIn. Scholar Rock® is a registered trademark of Scholar Rock, Inc. Availability of Other Information About Scholar Rock Investors and others should note that we communicate with our investors and the public using our company website www.scholarrock.com, including, but not limited to, company disclosures, investor presentations and FAQs, Securities and Exchange Commission filings, press releases, public conference call transcripts and webcast transcripts, as well as on X (formerly known as Twitter) and LinkedIn. The information that we post on our website, X, or LinkedIn could be deemed to be material information. As a result, we encourage investors, the media and others interested to review the information that we post there on a regular basis. The contents of our website or social media shall not be deemed incorporated by reference in any filing under the Securities Act of 1933, as amended. Forward-Looking Statements This press release contains "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995, including, but not limited to, statements regarding Scholar Rock’s future expectations, plans and prospects, including without limitation, Scholar Rock’s expectations regarding its growth, strategy, progress and timing of its clinical trials and development programs for apitegromab, including its subcutaneous formulation, SRK-439 and its preclinical programs, and indication selection and development timing, including the timing of any regulatory submissions, decisions and anticipated approvals, the therapeutic potential, clinical benefits and safety of any product candidates, expectations regarding actions by the FDA after its reinspection of the Catalent Indiana facility; the expected timing and outcome of FDA review of the accepted BLA for apitegromab, including the September 30, 2026 PDUFA action date; expectations regarding timing and outcome of EMA review and MAA approval; expectations regarding the availability and timing of commercial supply of apitegromab from Catalent Indiana and a second U.S.-based fill-finish facility, including expected supply from the second fill-finish facility; expectations regarding commercial launch timing, and the achievement of important milestones, the ability of any product candidate to perform in humans in a manner consistent with earlier nonclinical, preclinical or clinical trial data, the potential of its product candidates and proprietary platform. The use of words such as "may," "might," "could," "will," "should," "expect," "plan," "anticipate," "believe," "estimate," "project," "intend," "future," "potential," or "continue," and other similar expressions are intended to identify such forward-looking statements. All such forward-looking statements are based on management's current expectations of future events and are subject to a number of risks and uncertainties that could cause actual results to differ materially and adversely from those set forth in or implied by such forward-looking statements. These risks and uncertainties include, without limitation, whether preclinical and clinical data, including the results from the Phase 3 SAPPHIRE trial and any results from ongoing or future clinical trials, including the Phase 2 OPAL clinical trial, the Phase 2 FORGE trial and the Phase 1 clinical trial of SRK-439, will be sufficient to support regulatory approval or further development; that preclinical and clinical data, including the results from the Phase 2 or Phase 3 clinical trial of apitegromab, data from any ongoing or future trials of apitegromab or data for SRK-439, are not predictive of, may be inconsistent with, or more favorable than, data generated from future or ongoing clinical trials of the same product candidates; whether the FDA will accept the remediations to the Catalent Indiana fill finish facility in response to the FDA observations, whether the updated BLA, including a second fill finish facility, will be sufficient to support regulatory approval, Scholar Rock’s ability to manage expenses or provide the financial support, resources and expertise necessary to identify and develop product candidates on the expected timeline; information provided or decisions made by regulatory authorities; competition from third parties that are developing products for similar uses; Scholar Rock’s ability to obtain, maintain and protect its intellectual property; and Scholar Rock’s dependence on third parties for development and manufacture of product candidates including, without limitation, to supply any clinical trials as well as those risks more fully discussed in the section entitled "Risk Factors" in Scholar Rock’s Quarterly Report on Form 10-Q for the quarter ended June 30, 2026, as well as discussions of potential risks, uncertainties, and other important factors in Scholar Rock’s subsequent filings with the Securities and Exchange Commission. Any forward-looking statements represent Scholar Rock’s views only as of today and should not be relied upon as representing its views as of any subsequent date. All information in this press release is as of the date of the release, and Scholar Rock undertakes no duty to update this information unless required by law. View source version on businesswire.com: https://www.businesswire.com/news/home/20260806667041/en/ Contacts Investors Laura Ekas, [email protected] Media Jeff Smith682-401-8428Molly MacLeod, [email protected]

Enrollment complete in Phase 3 SONATA-HCM study; top-line data expected Q1 2027 NDA resubmission activities for ZYNQUISTA® in type 1 diabetes nearing completion Phase 1 clinical development of LX9851 ongoing by Novo Nordisk Conference call and webcast at 8:30 am ET THE WOODLANDS, Texas, Aug. 06, 2026 (GLOBE NEWSWIRE) -- Lexicon Pharmaceuticals, Inc. (Nasdaq: LXRX), today reported financial results for the three months ended June 30, 2026, and provided an update on key corporate milestones and accomplishments. “Lexicon continued to make strong progress during the second quarter, with the refinement of our strategy and sharpening of our focus beginning to bear fruit across our business,” said Mike Exton, Ph.D., Lexicon’s chief executive officer and director. “Among all the accomplishments, I’m particularly pleased that we have completed enrollment of our SONATA-HCM study on time, reflecting strong clinical interest for a novel class of medicine to treat HCM. Overall, I could not be more confident in how these opportunities are poised to shape the company over the coming months.” “We remain very focused on disciplined, targeted capital allocation as we continue to advance our clinical programs,” said Scott Coiante, Lexicon’s chief financial officer. “With early commercial planning now underway for our late-state pipeline, we are committed to maximizing the value of these opportunities to create long-term shareholder value.” Second Quarter 2026 Business and Pipeline Highlights Cardiometabolic Sotagliflozin Sotagliflozin is a unique oral inhibitor of sodium-glucose cotransporter types 1 and 2 (SGLT1 and SGLT2) and has been studied in approximately 20,000 patients across multiple cardiometabolic indications. Sotagliflozin is commercially available in the U.S. for heart failure as INPEFA®. Hypertrophic Cardiomyopathy (HCM) Enrollment has been completed in SONATA-HCM, a pivotal Phase 3 placebo-controlled study, substantially exceeding its enrollment target of 500 patients across both non-obstructive (nHCM) or obstructive HCM (oHCM). The primary efficacy endpoint will assess improvement in symptoms for the entire population (nHCM and oHCM). The final study population included a substantial majority of patients with nHCM, providing a robust opportunity to evaluate sotagliflozin in a patient group for whom effective treatment options remain limited, as well as a meaningful cohort of patients with oHCM. Lexicon continues to expect topline results in the first quarter of 2027. Type 1 Diabetes (T1D) (ZYNQUISTA®) Lexicon remains focused on bringing ZYNQUISTA to market for glycemic control in adults with T1D, a patient population for which there are no treatment options beyond insulin. STENO1, a third-party funded, investigator-initiated study of sotagliflozin being conducted by the STENO Diabetes Center (Denmark) is approaching the patient exposure and safety data requirements previously identified by the U.S. Food and Drug Administration (FDA) as being adequate to support a resubmission of the company's New Drug Application (NDA), which Lexicon anticipates will occur in the fourth quarter of 2026 based on current estimated timing of data collection. The safety data received to date from this open-label trial continue to support the resubmission. Viatris License for All Indications Ex-U.S. and Ex-Europe Lexicon continues to support licensee Viatris in its regulatory filing and commercial strategy for sotagliflozin outside of the U.S. and Europe. Viatris has obtained regulatory approval for heart failure in the United Arab Emirates and Bahrain and has submitted applications for regulatory approval for heart failure in several other markets, including Saudi Arabia, Canada, Australia, New Zealand, Mexico, Singapore, Oman, Thailand, Turkey, Malaysia, Philippines, and Kuwait. Viatris anticipates regulatory decisions in Australia and Canada and regulatory submissions in other markets in 2026. LX9851 LX9851 is a first-in-class, non-incretin, oral, small molecule inhibitor of acyl-CoA synthetase 5 (ACSL5) in development by licensee Novo Nordisk for obesity and associated metabolic disorders. Obesity and Associated Cardiometabolic Disorders In March 2026, Novo Nordisk initiated a Phase 1 study investigating single and multiple ascending doses of LX9851 compared to placebo in overweight or obese people. The Phase 1 program is expected to be completed in the first quarter of 2027. Under the terms of Lexicon’s exclusive license agreement with Novo Nordisk, Lexicon received an upfront payment of $45 million and two $10 million payments related to clinical development. Lexicon is eligible to receive a third $10 million milestone payment as early as later this year and up to an aggregate of $1 billion in upfront and development, regulatory and sales milestone payments. Lexicon is also eligible for tiered royalties on net sales of LX9851. Pilavapadin (LX9211) Discovered using Lexicon’s unique approach to gene science and target identification, pilavapadin is a potent, once-daily, orally delivered, selective, investigational small molecule inhibitor of AAK1. Lexicon identified AAK1 in its target discovery efforts as a promising approach for the treatment of neuropathic pain and is exploring its potential in other indications. Diabetic Peripheral Neuropathic Pain (DPNP) Pilavapadin has the potential to be the first oral, non-opioid drug therapy approved in neuropathic pain in more than 20 years. Lexicon continues to explore strategic opportunities to maximize the global potential of this investigative therapy. Second Quarter 2026 Financial Highlights Revenues: Total revenues were $0.7 million for the second quarter of 2026, consisting of net sales of INPEFA. Total revenues for the second quarter of 2025 were $28.9 million, consisting of $27.6 million in licensing revenue recognized from the Novo Nordisk licensing agreement and $1.3 million from net sales of INPEFA. Research and Development (R&D) Expenses: Research and development expenses for the second quarter of 2026 increased to $17.4 million from $15.7 million for the corresponding period in 2025, reflecting higher external research expense in 2026 related to the Company’s ongoing SONATA-HCM Phase 3 clinical trial. Selling, General and Administrative (SG&A) Expenses: Selling, general and administrative expenses for the second quarter of 2026 increased to $9.8 million from $9.4 million for the corresponding period in 2025. The increase in 2026 reflects higher professional and consulting costs. Net Loss: Net loss for the second quarter of 2026 was $31.8 million, or $0.07 per share, as compared to net income of $3.3 million, or $0.01 per share, in the corresponding period in 2025. Net loss for the second quarter of 2026 and net income for the second quarter of 2025 included non-cash, stock-based compensation expense of $3.3 million and $3.2 million, respectively. Cash, Investments and Restricted Cash: As of June 30, 2026, Lexicon had $190.6 million in cash and investments, as compared to $125.2 million in cash, investments, and restricted cash as of December 31, 2025. The increase in cash and investments reflects net proceeds of $96.2 million from the sale of common and preferred stock in February 2026. Hercules Capital Loan FacilityIn May 2026, Lexicon entered into a $100 million loan facility with Hercules Capital. An initial $55 million tranche was funded at closing and used to repay Lexicon’s previous loan facility with Oxford Finance. The second $20 million tranche is available for draw at Lexicon’s option subject to the achievement of certain clinical, regulatory and financial milestones and specified timing requirements. The third $25 million tranche is available for draw at Lexicon’s option subject to Hercules’ consent and specified timing requirements. Conference Call and Webcast Information  Lexicon management will hold a live conference call and webcast today at 8:30 am ET / 7:30 am CT to review its financial and operating results and to provide a general business update. A live audio webcast of the call can be accessed by visiting the Events page of the Company’s investor relations website at https://investors.lexpharma.com/. Participants who wish to ask a question may join by phone at 800-715-9871 and use passcode 9826247. An archived version of the webcast will be available on the website for 30 days. About Lexicon Pharmaceuticals Lexicon is a biopharmaceutical company with a mission of pioneering medicines that transform patients’ lives. Lexicon has a pipeline of drug candidates in discovery, preclinical, and clinical development in neuropathic pain, hypertrophic cardiomyopathy (HCM), obesity and metabolic disorders, and other cardiometabolic indications. For additional information, please visit www.lexpharma.com. Safe Harbor Statement This press release contains “forward-looking statements,” including statements relating to Lexicon’s financial position and long-term outlook on its business, including the commercialization of its approved products and the clinical development of regulatory filings for, and potential therapeutic and commercial potential of its other drug candidates. In addition, this press release also contains forward looking statements relating to Lexicon’s growth and future operating results, discovery, development and commercialization of products, strategic alliances and intellectual property, as well as other matters that are not historical facts or information. All forward-looking statements are based on management’s current assumptions and expectations and involve risks, uncertainties and other important factors, specifically including Lexicon’s ability to meet its capital requirements, successfully commercialize its approved products, successfully conduct preclinical and clinical development and obtain necessary regulatory approvals of its other drug candidates on its anticipated timelines, achieve its operational objectives, obtain patent protection for its discoveries and establish strategic alliances, as well as additional factors relating to manufacturing, intellectual property rights, and the therapeutic or commercial value of its approved products and other drug candidates. Any of these risks, uncertainties and other factors may cause Lexicon’s actual results to be materially different from any future results expressed or implied by such forward-looking statements. Information identifying such important factors is contained under “Risk Factors” in Lexicon’s annual report on Form 10-K for the year ended December 31, 2025, as filed with the Securities and Exchange Commission. Lexicon undertakes no obligation to update or revise any such forward-looking statements, whether as a result of new information, future events or otherwise. For Media Inquiries:Dave BelianLexicon Pharmaceuticals, [email protected] For Investor Inquiries:Lisa DeFrancescoLexicon Pharmaceuticals, [email protected]

This article first appeared on GuruFocus. Total Revenue: $0.7 million for Q2 2026, compared to $28.9 million in Q2 2025. Licensing Revenue: Q2 2025 included $27.5 million in licensing revenue from the Novo Nordisk agreement; no comparable revenue was recognized in Q2 2026. R&D Expenses: $17.4 million in Q2 2026, up from $15.7 million in Q2 2025, driven by higher external costs for the SONATA HCM Phase III trial. SG&A Expenses: $9.8 million in Q2 2026, compared to $9.4 million in Q2 2025. Net Loss: $31.8 million, or $0.07 per share, in Q2 2026, versus net income of $3.3 million, or $0.01 per share, in Q2 2025. Non-Cash Stock-Based Compensation: $3.3 million in Q2 2026 and $3.2 million in Q2 2025. Loss on Early Extinguishment of Debt: $4.3 million, or $0.01 per share, in Q2 2026 from early repayment of term loans with Oxford Finance. Cash Position: $190.6 million in cash equivalents and short-term investments as of June 30, 2026, versus $125.2 million in cash equivalents, short-term investments, and restricted cash as of December 31, 2025. 2026 Operating Expense Guidance: Reiterated at $100 million to $110 million, with R&D between $63 million and $68 million and SG&A between $37 million and $42 million. Warning! GuruFocus has detected 5 Warning Signs with LXRX. Is LXRX fairly valued? Test your thesis with our free DCF calculator. Release Date: August 06, 2026 For the complete transcript of the earnings call, please refer to the full earnings call transcript. Lexicon Pharmaceuticals Inc (NASDAQ:LXRX) completed enrollment in its Phase 3 SONATA HCM trial, which was significantly over-enrolled, potentially improving the study's statistical power. The company expects to meet all FDA criteria for resubmitting the Zynquista NDA, with DKA rates in the STENA-1 study similar to standard of care and below those seen in prior trials. Lexicon Pharmaceuticals Inc (NASDAQ:LXRX) anticipates completing the Zynquista NDA resubmission in Q4 2026, with potential for a faster-than-standard FDA review. The company strengthened its balance sheet with a new $100 million debt facility from Hercules Capital, improving financial flexibility. Lexicon Pharmaceuticals Inc (NASDAQ:LXRX) is advancing its pipeline, including LX-9851 for obesity with licensee Novo Nordisk, and has potential to receive a third $10 million milestone payment later this year. The company is exploring new high-value indications for pilavapidin, with preclinical data expected later this year. Lexicon Pharmaceuticals Inc (NASDAQ:LXRX) reported a net loss of $31.8 million for Q2 2026, a significant decline from net income of $3.3 million in the same period of 2025. Total revenues dropped sharply to $0.7 million in Q2 2026 from $28.9 million in Q2 2025, primarily due to the absence of a one-time licensing fee from Novo Nordisk. The Zynquista NDA resubmission timeline was delayed to Q4 2026, slightly later than previously anticipated. The company incurred a $4.3 million loss on the early extinguishment of debt related to repaying its Oxford Finance term loans. Lexicon Pharmaceuticals Inc (NASDAQ:LXRX) faces uncertainty regarding the commercial potential of sotagliflozin in HCM, as the trial includes a mix of obstructive and non-obstructive patients, and the exact patient breakdown on cardiac myosin inhibitors has not been disclosed. The company's cash position of $190.6 million may be insufficient to fund all operations and milestones without additional financing or successful commercialization. Q: On SONATA, given the substantial majority of NHCM patients with a meaningful OHCM cohort, how should we think about the mix in terms of commercial and regulatory value if the overall population is positive? Is directionality across both phenotypes more important than the exact magnitude in each group?A: Craig Granowitz (CMO): The trial is powered on the overall population, which was discussed with the FDA and includes both obstructive and non-obstructive patients. The significant over-enrollment gives us even more confidence in the primary endpoint. While there are more non-obstructive patients, there is a significant enough number of obstructive patients to find meaningful results in both groups. Mike Exton (CEO) added that commercially, there is opportunity across the spectrum, as obstructive patients remain symptomatic despite approved agents, and non-obstructive patients have no approved options. Sotagliflozin is the only SGLT inhibitor in HCM, applicable as a solo treatment or in combination with cardiac myosin inhibitors. Q: On type 1 diabetes, you're resubmitting in Q4 versus mid-26 before. Can you talk about why it's taking longer to accrue data?A: Craig Granowitz (CMO): STENA-1 is an investigator-initiated trial never designed for regulatory purposes. We've been working continuously with Steno to pull data together in the format the FDA requires, which is taking more time. The most important aspect is that the trial has achieved the exposure required by the FDA for both sotagliflozin and the control group. The rates of diabetic ketoacidosis (DKA) in the SOTA-treated group are similar to standard of care and well below those observed in the In Tandem trials. Mike Exton (CEO) added that submission could be as early as end of October, which with a six-month review would put approval in Q2 2027, though they will work proactively with the FDA to potentially expedite the review. Q: On SONATA, are you able to share the proportion of patients on cardiac myosin inhibitors (CMIs) and how that might impact overall results and future prescribing? What does the majority NHCM mean for the OHCM proportion?A: Craig Granowitz (CMO): We haven't broken out the proportions and probably won't until we share baseline characteristics at an upcoming medical meeting. There are a fair number of patients on a CMI, but availability was limited since the trial included 20 countries and the US, while the largest single enrolling country, was not a majority. The protocol required patients to be on a stable dose of underlying HCM medications for at least six months. The single unifying characteristic of the trial is that all patients have a baseline KCCQ score of less than 85, which is the gold standard for managing symptomatic relief. Q: Could you give us your updated thoughts on where sotagliflozin fits into the HCM landscape, given other biotechs are gearing up for Phase 3 trials? How do you see prescribers making decisions between programs?A: Mike Exton (CEO): Sotagliflozin is a complementary mechanism to currently approved and newer agents. It has unique attributes that support first-line use: it's an oral, once-a-day medicine that is extremely well tolerated and safe, with broad access for patients. We see it naturally as an option that a broad range of physicians could turn to immediately for symptomatic HCM, with the possibility of adding a CMI if patients remain symptomatic. Q: The population contains both obstructive and non-obstructive, and the study is powered for KCCQ in both. How do you envision exploring optionality if there is statistical separation in one population versus another? What work goes into that, and how much flexibility do you have before locking the database?A: Craig Granowitz (CMO): We are taking a hard look at the statistical analysis plan (SAP) as we complete enrollment. The primary endpoint of KCCQ score at week 26 in the overall population will not change. However, depending on how the market unfolds, there might be shifts in the order of the hierarchy in the statistical plan. We are aligned internally and with our external scientific advisory board that the primary endpoint remains unchanged. Q: What type of data were generated by the PI for Zynquista as well as in-house to correlate together to ensure a near-complete filing, and what is the timing around that?A: Craig Granowitz (CMO): The interaction with Steno has been extensive. We receive monthly updates on patient enrollment and DKA cases, have detailed narratives of every DKA patient, and have been in continuous dialogue with the PIs. We've examined their database, electronic medical records, and the ability to download data into SAS format for FDA submission. We've agreed on key variables for baseline characteristics and exposure. Mike Exton (CEO) added that the exposure on sotagliflozin is now just a little less than the entire In Tandem program, and DKA rates are similar to standard of care, making this compelling data as they approach NDA submission. Q: On LX-9851, how should we think about the bar for continued development coming around Phase 1? What would constitute a supportive data package for Novo to move the program forward?A: Mike Exton (CEO): The bar for development is now a question for Novo Nordisk. We're incredibly pleased with how the partnership has progressed. Novo is very enthusiastic about the mechanism, and the Phase 1 trial is progressing extremely well. We've always thought that combinations of different mechanisms of oral medicines will be important in obesity, and Novo, as the leader in oral weight loss medicines, is taking that approach with LX-9851. Q: Can you elaborate on the financial results for the quarter and the company's balance sheet position?A: Scott Coiante (CFO): Total revenues were $0.7 million for Q2 2026, compared to $28.9 million in Q2 2025, which included $27.5 million in licensing revenue from Novo Nordisk. R&D expenses were $17.4 million, reflecting higher external costs for the SONATA HCM Phase 3 trial. Net loss was $31.8 million, or $0.07 per share, including a $4.3 million loss on early extinguishment of debt. As of June 30, 2026, the company had $190.6 million in cash and short-term investments. In May, the company announced a $100 million debt facility with Hercules Capital, with an initial $55 million tranche funded to repay the Oxford Finance loan. The company reiter For the complete transcript of the earnings call, please refer to the full earnings call transcript.