NVO

Novo NVO is a dominant player in the cardiometabolic space, mainly due to the encouraging uptake of its blockbuster semaglutide-based (GLP-1) drugs — Ozempic (for type II diabetes [T2D]), Rybelsus (for T2D) and Wegovy (for obesity). Since launch, Novo has steadily expanded the commercial opportunity for both Ozempic and Wegovy through multiple label expansions. Together, the drugs generated approximately DKK 112.2 billion in the first half of 2026, accounting for about 75.5% of NVO's adjusted sales. Investors will be particularly interested in the sales numbers for these two drugs when Novo reports third-quarter 2026 results on Nov. 4. Novo has also broadened its oral semaglutide franchise. Following FDA approval in late December 2025, the oral Wegovy pill became available in the United States in early January 2026, offering a more convenient alternative to injectable treatment. The pill has demonstrated strong early uptake, with Novo reporting more than five million U.S. prescriptions since launch by the second-quarter reporting period. In July 2026, Wegovy pill received European regulatory approval for obesity, following launches in the UAE in June and the United Kingdom in early July. These international launches are likely to have contributed to additional sales growth in the to-be-reported quarter. Beyond obesity, Novo is expanding its diabetes portfolio with oral semaglutide. The FDA approved the Ozempic tablet brand in February 2026, and Novo made the pills available in the United States in May for adults with T2D, including those at high cardiovascular risk. The launch offers an additional growth opportunity, with investors keen to assess early uptake when Novo reports third-quarter results. Novo continues to generate meaningful revenues from Rybelsus, its oral semaglutide therapy for T2D, although the company reports Ozempic pill and Rybelsus sales together. Despite raising its 2026 outlook following the second quarter, Novo still expects adjusted sales and operating profit to range from flat to a 6% decline at CER. This outlook underscores the challenges facing Novo's GLP-1 franchise, suggesting third-quarter sales growth for Wegovy and Ozempic are likely to have remained under pressure, particularly in the United States amid intensifying competition from arch-rival Eli Lilly LLY. Pricing pressure, weaker prescription trends for its injectable GLP-1 drugs, reduced Medicaid coverage for obesity treatments, and intensifying competition remain significant operational and executional challenges. Beyond its GLP-1 franchise, Novo's insulin and Rare Disease portfolios are likely to have provided additional support to overall revenues during the period. Eli Lilly is Novo's fierce competitor in the diabetes/obesity space, which markets its tirzepatide injections, Mounjaro (T2D) and Zepbound (obesity), competing directly with NVO's Ozempic and Wegovy injections, respectively. Mounjaro and Zepbound have become LLY's key top-line drivers. In the first half of 2026, the two drugs generated $27.7 billion in combined sales, up approximately 88% year over year and accounting for about 65% of Lilly's total revenues. Eli Lilly also secured FDA approval and subsequently launched its oral GLP-1 pill, Foundayo (orforglipron), for obesity in early April, which now competes directly with Novo Nordisk's Wegovy pill. Investors will closely monitor Foundayo's commercial momentum when Lilly reports third-quarter results on Oct. 29, 2026. The obesity space has drawn much of the spotlight over the past year because of the sizeable and still underpenetrated market opportunity. Smaller biotech firms, such as Viking Therapeutics VKTX and Structure Therapeutics GPCR, are also advancing GLP-1–based therapies to challenge the incumbents. Viking Therapeutics' dual GIPR/GLP-1 RA, VK2735, is being developed in both oral and subcutaneous formulations for the treatment of obesity. Viking recently announced initiating the phase III SUNRISE program, comprising two late-stage studies, evaluating oral VK2735 in adults with obesity and in obese or overweight adults with T2D. Structure Therapeutics' phase II ACCESS program on its orally administered small molecule GLP-1 RA, aleniglipron, demonstrated significant weight loss across all doses. Based on such encouraging results, Structure Therapeutics has initiated dosing patients in its late-stage ACCOMPLISH program to evaluate aleniglipron for chronic weight management. 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 Eli Lilly and Company (LLY) : 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

Eli Lilly LLY is a dominant player in the cardiometabolic market, backed by a strong and expanding GLP-1 portfolio. Its GLP-1 lineup includes Mounjaro and Zepbound (tirzepatide injections) for type II diabetes (T2D) and obesity, respectively, and the newly approved oral obesity therapy, Foundayo (orforglipron). Lilly's growth has been primarily fueled by the blockbuster success of Mounjaro and Zepbound, whose strong demand has made them the company's primary revenue drivers. In the first half of 2026, the two drugs generated $27.7 billion in combined sales, up approximately 88% year over year and accounting for about 65% of Lilly's total revenues. Investors will closely monitor their performance when LLY reports third-quarter results on Oct. 29, 2026. Mounjaro and Zepbound have delivered strong growth in recent quarters, supported by robust demand, expanded manufacturing capacity and continued international market expansion, with sales expected to remain strong in the third quarter of 2026. Mounjaro continued to gain ground in the U.S. T2D market, while Zepbound captured nearly 60% of total prescriptions in the U.S. branded obesity market by the end of the second quarter. Overall, Lilly held 60.9% of the U.S. incretin-analog market by prescriptions as of June, while its share of the international market by sales reached 54.9% in April–May. The robust momentum of its GLP-1 franchise is a key driver underpinning Eli Lilly's upbeat 2026 revenue outlook of $85-$87 billion. Investors will closely monitor Foundayo's commercial momentum when Lilly reports third-quarter results. Launched in April, the oral GLP-1 generated $98 million in second-quarter sales. Coverage through all three major U.S. pharmacy benefit managers expanded during the second quarter, while eligible Medicare beneficiaries gained access through the GLP-1 Bridge program on July 1, making the third quarter the first full quarter with this additional coverage channel. Foundayo's obesity indication is also under regulatory review in more than 40 countries, with a global rollout targeted for 2027. Investors will look for updates on Foundayo's obesity sales, the FDA's review of Lilly's separate application for T2D use and international expansion plans to gauge the drug's long-term growth potential. Beyond cardiometabolic health, Lilly's broader portfolio, including the oncology drug Verzenio and immunology drug Taltz, also continues to deliver steady growth. The company's newer drugs, including Omvoh and Ebglyss in immunology, Jaypirca in oncology, and Kisunla in neuroscience, are all contributing to top-line growth. Eli Lilly and Novo NVO presently dominate the obesity market. Mounjaro and Zepbound directly compete with NVO's semaglutide medicines, Ozempic for T2D and Wegovy for obesity. Like Eli Lilly, Novo also generates a substantial portion of revenues from both drugs. Novo gained approval for an oral version of its obesity drug, Wegovy, in December 2025 and launched the pill in January 2026, which gave it a first-mover advantage over Foundayo. However, Lilly may close the gap soon. Oral pills will be a more convenient alternative to the currently available once-weekly injectable obesity treatments like Zepbound and Wegovy. The obesity space has drawn much of the spotlight over the past year because of the sizeable and still underpenetrated market opportunity. Smaller biotech firms, such as Viking Therapeutics VKTX and Structure Therapeutics GPCR, are also advancing GLP-1–based therapies to challenge the incumbents. Viking Therapeutics' dual GIPR/GLP-1 RA, VK2735, is being developed in both oral and subcutaneous formulations for the treatment of obesity. Viking recently announced initiating the phase III SUNRISE program, comprising two late-stage studies, evaluating oral VK2735 in adults with obesity and in obese or overweight adults with T2D. Structure Therapeutics' phase II ACCESS program on its orally administered small molecule GLP-1 RA, aleniglipron, demonstrated significant weight loss across all doses. Based on such encouraging results, Structure Therapeutics has initiated dosing patients in its late-stage ACCOMPLISHprogram to evaluate aleniglipron for chronic weight management. 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

It's been a rough past two years for Novo (NYSE: NVO). The healthcare giant has lost market share in the GLP-1 industry, leading to a more than 60% drop in its share price. Novo is now trading at 11.8x forward earnings, well below the 18.6x average for healthcare stocks. Is Novo far too cheap to ignore at current levels? Or is it a value trap? Let's find out. Missed AI's "Act 1"? Act 2 Could Be 14x Bigger. Most investors think they missed the AI boat because they didn't buy Nvidia in 2005. But according to our analysts, we're only at the end of "Act 1"—the R&D phase. "Act 2" is the global rollout. Continue » Novo generates the lion's share of its revenue from its GLP-1 products, particularly Wegovy, a weight-loss medicine, and Ozempic, a diabetes drug. Competition from Eli Lilly (NYSE: LLY) has led to declining sales growth for both products. But that's only part of the story. Another issue is that Novo has experienced several clinical setbacks, prompting many investors to question whether it can remain a leader in the GLP-1 space. For instance, the company's CagriSema, although highly effective, fell short of management's 25% mean weight-loss target in a Phase 3 study. Also, CagriSema lost to Eli Lilly's Zepbound in a head-to-head weight-loss clinical trial. CagriSema could earn approval by the end of the year, but based on clinical trial data, it may not allow Novo to close the gap with Eli Lilly. Further, Novo has also experienced setbacks outside of its core area of expertise. For instance, the company's ziltivekimab failed to show significant efficacy in a Phase 3 clinical trial targeting risk reduction of major adverse cardiovascular events in patients with atherosclerotic cardiovascular disease, chronic kidney disease, and inflammation. This setback dealt a blow to Novo's efforts to diversify its pipeline. Some analysts projected that ziltivekimab could achieve peak revenue of about $3 billion, and in fairness, the medicine is undergoing studies in other indications. Still, it was yet another letdown for a company that is desperate for wins. Meanwhile, Novo's financial results have been mediocre. In the second quarter, the company's net sales increased by just 2% year over year to 78.5 billion Danish kroner (about $11.8 billion), while its adjusted earnings per share came in at 6.18 DKK (about $0.93), 5% higher than the prior-year quarter. There has been one area where Novo has made good progress: The oral weight loss market. In January, the company launched the Wegovy pill, the first oral GLP-1 medicine approved for weight loss. Oral Wegovy has helped the company expand its addressable market. As it pointed out, as of June, more than three million prescriptions had been filled in the U.S., and more than 80% of them were for people who had never taken GLP-1s before. Oral Wegovy won't be enough to allow the company to bounce back, though. Novo will have to develop new products. The good news is that the Denmark-based pharmaceutical giant boasts several exciting candidates. One of them is called zenagamtide. It is currently undergoing Phase 3 studies for weight loss. There are at least two things to note about this investigational medicine. First, it mimics the action of two gut hormones: GLP-1 and amylin. Novo hopes that the dual-hormone pathway approach will yield greater efficacy. Second, and relatedly, zenagamtide has already posted very promising clinical trial results. In a Phase 1b/2a study, it resulted in a mean weight loss of up to 24.3% over 36 weeks. If it can deliver similarly strong results over longer periods in Phase 3 studies, it could eventually become a leader in the weight-loss market and help Novo improve its position in the industry. Novo has several other promising pipeline candidates, including some triple agonists (medicines that mimic the actions of three gut hormones). The healthcare company is also pursuing diversification efforts, with several products in Phase 2 and Phase 3 studies. Novo's pipeline is deep, and even though it's important to recognize that some of its advanced programs might fail, my view is that the market has already partially factored this into the share price after recent clinical setbacks. Novo's outlook remains somewhat uncertain, but at current levels, it could gain substantial market value over the next five years, provided it can expand its approved portfolio. Is Novo the buying opportunity of the decade? Not really. There's too much uncertainty for that to be the case. But at current levels, it could deliver solid returns over the medium term. Before you buy stock in Novo Nordisk, consider this: The Motley Fool Stock Advisor analyst team just identified what they believe are the 10 best stocks for investors to buy now… and Novo Nordisk wasn't one of them. The 10 stocks that made the cut could produce monster returns in the coming years. Consider when Netflix made this list on December 17, 2004... if you invested $1,000 at the time of our recommendation, you'd have $380,363!* Or when Nvidia made this list on April 15, 2005... if you invested $1,000 at the time of our recommendation, you'd have $1,315,732!* Now, it's worth noting Stock Advisor's total average return is 919% — a market-crushing outperformance compared to 211% for the S&P 500. Don't miss the latest top 10 list, available with Stock Advisor, and join an investing community built by individual investors for individual investors. See the 10 stocks » *Stock Advisor returns as of October 18, 2026. Prosper Junior Bakiny has positions in Eli Lilly and Novo Nordisk. The Motley Fool has positions in and recommends Eli Lilly and Novo Nordisk. The Motley Fool has a disclosure policy. Novo Trades at Less Than 12 Times Earnings. Is This the Buying Opportunity of the Decade? was originally published by The Motley Fool

Novo Nordisk announced real-world data on Wednesday showing that adults with obesity or overweight who switched from injectable weight loss drugs to its daily Wegovy pill continued shedding pounds over the following three months. The study, called OCTANE, tracked 194 patients enrolled in the Ro telehealth platform who moved from either Novo's Wegovy injection or Eli Lilly's Zepbound to once-daily oral semaglutide. Over that three-month window, participants who remained on the pill shed an average of 4.1% of their body weight — roughly 8.8 pounds — having started at approximately 221 pounds, according to the company. About two in five participants reached the 5% weight-loss threshold, while the proportion meeting the clinical definition of obesity — a BMI of 30 or higher — declined to 65.5% from 87.1%. Of those for whom data existed, 82% noted at least one positive change while on the pill; the most commonly cited were improved clothing fit, mentioned by about 70%, and a shift toward better nutrition, reported by around 51%, the company said. Around 75% of participants reported satisfaction with the switch to a pill, the company said. The findings were presented at the European Association for the Study of Diabetes annual meeting in Milan on Wednesday. "There's been a lot of questions on can people be compliant to the pill? Do people really prefer the pill? Clearly, a lot of patients do even better on the pill than they did on the (injectable) drugs, and I think that is strong data," Martin Holst Lange, Novo's chief scientific officer, told Reuters. Novo acknowledged meaningful limitations. The analysis relied partly on self-reported data, which is subject to bias, and requiring patients to remain on treatment could introduce selection bias. The company also said results may not apply to the broader population. The OCTANE data arrive as Novo works to defend its position in the oral obesity drug market. The Wegovy pill has been positioned against Eli Lilly's newly approved obesity tablet Foundayo, with the two companies competing for prescribing trends in a market some analysts estimate could exceed $100 billion annually by the end of the decade. According to Reuters, the oral segment has grown to represent about one-third of all U.S. obesity prescriptions, and Novo holds more than 80% of new prescriptions written in that category. Since its debut, the Wegovy pill has exceeded 5 million prescriptions in the U.S. and is now sold in four markets: the U.S., United Kingdom, Germany, and the United Arab Emirates, the company said. Novo said it plans to launch the pill in additional markets in coming quarters.

Roche's push into the obesity market has received another boost after its experimental drug, enicepatide, helped overweight or obese patients with type 2 diabetes improve blood sugar control while losing an average of 15.5% of their body weight in a mid-stage trial. The results add another potentially important asset to Roche's efforts to challenge obesity-market leaders Eli Lilly and Company (NYSE:LLY) and Novo Nordisk A/S (NYSE:NVO). Competition is also growing beyond the two incumbents, with companies including AstraZeneca PLC (NYSE:AZN) and Amgen Inc. (NASDAQ:AMGN) racing to develop new treatments. DON'T MISS: Gilead vs. Abbott: Which Dividend Healthcare Stock Offers the Better Risk-Reward? For Roche, the opportunity is substantial because the company is betting on next-generation therapies in an obesity market expected to exceed $100 billion in annual sales within the next decade. Enicepatide still has significant clinical development ahead, but its latest results give investors another indication of how Roche plans to compete for a piece of that market. Enicepatide is a once-weekly injection designed to mimic the GLP-1 and GIP hormones, helping regulate blood sugar and reduce appetite. In the 447-patient mid-stage study, patients receiving the highest 24-milligram dose experienced significant reductions in HbA1c at 48 weeks, meeting the study's two main goals. HbA1c measures blood-glucose levels over time. Roche said approximately 62% of patients achieved HbA1c levels below 5.7%, putting their blood sugar into the non-diabetic range. Those findings follow another mid-stage result reported in June, when the company reported that in that study, enicepatide helped overweight or obese patients without diabetes lose 22.7% of their body weight. The two weight-loss figures should not be directly compared because they come from separate trials involving different patient populations. Taken individually, however, both provide clinical evidence supporting Roche's decision to continue developing enicepatide. DON'T MISS: Pfizer vs. Thermo Fisher: Which Healthcare Turnaround has More Upside? The next step is already taking shape with Roche planning to begin late-stage glycemic-control and cardiovascular-outcomes studies during the first half of 2027. Advancing into late-stage development would move enicepatide closer to answering the larger question of whether Roche can establish a meaningful position in the increasingly competitive obesity market. Despite the encouraging mid-stage results, enicepatide remains an experimental drug, and Roche still has substantial clinical work ahead before it could become a commercial competitor to established obesity treatments. The planned late-stage studies are not expected to begin until the first half of 2027, which means the latest results should not be treated as evidence of regulatory approval or eventual commercial success. Tolerability will also remain an important part of the drug's development. Roche said around 2% of patients taking enicepatide in the 447-patient study discontinued treatment because of side effects, compared with none in the placebo group. Most gastrointestinal side effects were described by the company as mild to moderate. Competition presents another challenge for the company. Roche is not entering an undeveloped market, but rather one where Eli Lilly and Novo Nordisk are already the leaders, while AstraZeneca and Amgen are among the large drugmakers also racing to break into obesity treatments. The scale of the potential market therefore cuts both ways. Expectations that annual obesity-drug sales could eventually exceed $100 billion help explain Roche's investment in next-generation therapies, but the size of the opportunity is also attracting significant competition. Enicepatide gives Roche another credible clinical program around which to build its obesity ambitions. The latest study met its two main goals, with the highest dose producing significant improvements in HbA1c alongside average weight loss of 15.5%. That follows the separate June study showing 22.7% weight loss among overweight or obese patients without diabetes. But Roche is still approaching the stage where the evidence will become more demanding. Enicepatide remains in mid-stage development, with late-stage glycemic-control and cardiovascular-outcomes studies planned for the first half of 2027. For now, the results strengthen Roche's case for continuing to invest in enicepatide. Whether the drug can eventually challenge Eli Lilly and Company (NYSE:LLY) and Novo Nordisk A/S (NYSE:NVO) will depend on what Roche can demonstrate as the program moves into late-stage testing. While we acknowledge the potential of LLY and NVO as an investment, we believe certain AI stocks offer greater upside potential and carry less downside risk. If you're looking for an extremely undervalued AI stock that also stands to benefit significantly from Trump-era tariffs and the onshoring trend, see our free report on the best short-term AI stock. READ NEXT: Can Eli Lilly Catch Novo Nordisk in the Oral GLP-1 Race? AND Abbott vs. Intuitive Surgical: Is Consistent Growth Better Than Premium Growth? This article is originally published at Insider Monkey.

Shares of Viking Therapeutics VKTX rose about 36% on Tuesday after the company announced positive data from a maintenance dosing study evaluating its lead obesity candidate, VK2735. Results showed that participants preserved most of their weight loss from the induction phase even when dosing frequency was materially reduced. Year to date, the company’s shares have gained 16% compared with the industry’s 7% growth. Image Source: Zacks Investment Research The maintenance study was designed to examine whether weight loss achieved with weekly VK2735 treatment could be sustained after reducing the frequency of dosing. The study consisted of two main phases — an induction phase lasting 21 weeks followed by a 12-week maintenance phase. During the induction phase, participants received weekly subcutaneous VK2735 or placebo. Among those receiving VK2735, the doses increased gradually over the first several weeks. Patients received 1.25 mg in week 1 and 2.5 mg in week 2, after which doses were increased roughly every two weeks until final doses of 15 mg, 17.5 mg, 20 mg or 22.5 mg were reached. The study’s distinctive part came after the induction phase. Study participants who had received weekly VK2735 were moved to less-frequent dosing, with different groups receiving the drug either once every other week or once a month for an additional 12 weeks. The study also included patients who were switched to placebo, providing a comparison for how much of their earlier weight loss was retained after active treatment was stopped. Viking also included a separate group that continued receiving 17.5 mg of VK2735 once weekly through week 33. This provided a reference for the outcomes of continued weekly treatment compared with the less-frequent maintenance regimens. This design matters because it tests more than VK2735’s ability to drive weight loss. It also asks whether patients can maintain most of that benefit while taking the drug less often, which could become an important differentiating feature for long-term use. During the 21-week induction phase, participants treated with VK2735 lost roughly 16% to 19% of their body weight, while the placebo group showed a 0.1% decline. Much of that weight loss was preserved even after dosing became less frequent. Participants who moved to every-other-week dosing maintained an average of 90% of their earlier weight loss, while those switched to monthly dosing maintained an average of 85%. In comparison, participants who switched to placebo retained about 61% of their prior weight loss. At the individual cohort level, weight-loss retention reached as high as 97% with every-other-week dosing and 90% with monthly dosing. The findings suggest that VK2735 could allow patients to reduce injection frequency after losing weight without giving up most of the benefit. Meanwhile, participants who continued receiving 17.5 mg once weekly kept losing weight, reaching 21.7% weight loss from baseline by week 33 versus 0.3% weight gain in those who received placebo. Viking noted that no weight-loss plateau was observed. VK2735 was also generally well tolerated during the maintenance period. Per the company, gastrointestinal side effects, such as nausea, vomiting, diarrhea and constipation, were not meaningfully different from placebo after participants moved to every-other-week or monthly dosing. Viking is also on track to start part 2 of the maintenance study, which will explore SC to oral maintenance dosing regimens. This portion is expected to start later this quarter. The maintenance results could strengthen VK2735’s position in the competitive obesity-drug market. Viking is developing the candidate as a potential alternative to established GLP-1 injectables — Eli Lilly’s LLY Zepbound and Novo Nordisk’s NVO Wegovy. The ability to maintain substantial weight loss with every-other-week or monthly dosing could give VK2735 an additional point of differentiation. VK2735 is the company's lead obesity candidate and primary value driver. This dual GLP-1/GIP receptor agonist is being developed in both SC and oral formulations, positioning it as one of the more promising late-stage obesity therapies currently under development. While the SC version is currently being evaluated in two phase III studies, oral VK2735 is on track to enter late-stage development before this year’s end. Competition in obesity treatment is also expanding beyond once-weekly injections toward more convenient oral options. Earlier this year, Novo Nordisk launched an oral version of Wegovy, while Eli Lilly introduced its once-daily oral GLP-1 drug Foundayo. This shift increases the importance of convenience as companies compete not only on weight-loss efficacy but also on how treatments are administered and how often patients need to take them. Viking Therapeutics, Inc. price | Viking Therapeutics, Inc. Quote Viking Therapeutics currently carries a Zacks Rank #3 (Hold). You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here. Want the latest recommendations from Zacks Investment Research? Today, you can download 7 Best Stocks for the Next 30 Days. Click to get this free report Viking Therapeutics, Inc. (VKTX) : Free Stock Analysis Report Novo Nordisk A/S (NVO) : Free Stock Analysis Report Eli Lilly and Company (LLY) : Free Stock Analysis Report This article originally published on Zacks Investment Research (zacks.com). Zacks Investment Research

Viking Therapeutics surged 26% after VK2735 maintenance data validated monthly and every-other-week dosing schedules, directly addressing the adherence problem plaguing injectable GLP-1s. Obesity peers shrugged at the results, with Structure falling, Lilly gaining 1%, and Novo slipping, as traders read the news as company-specific validation rather than a sector-wide catalyst. With $502 million in cash and two fully enrolled Phase 3 trials, Viking holds leverage to operate on its own timeline rather than accept acquisition terms. Just released. Our analysts combed the entire stock market and named the ten best stocks to buy right now, and Viking Therapeutics didn't make the cut. Enter your email to see the names that beat VKTX. The report is free. Enter your email and see if any of your stocks made the cut. Viking Therapeutics (NASDAQ:VKTX) traded at $38.08, a session gain of 26.5%, as of 11:42 a.m. ET on September 22, 2026, after the company released positive topline results from the maintenance dosing study of its lead GLP-1/GIP agonist VK2735. The move was almost entirely Viking's own; the rest of the obesity complex barely twitched. Viking's September 22, 2026, release covers a randomized, double-blind, placebo-controlled trial of VK2735 in adults with obesity. Participants took weekly subcutaneous induction dosing, then transitioned to less frequent maintenance regimens including every-other-week and monthly schedules. CEO Brian Lian previewed the design in July, saying the study "is designed to explore the effects of various maintenance regimens, including monthly and every other week dosing." The company framed the data as validating multiple maintenance schedules, a commercially significant finding because patient adherence is a well-known weakness of injectable GLP-1s. These are company-reported topline results and have not yet undergone peer review or regulatory review. Prior Phase 2 work set the bar. VENTURE showed up to 14.7% mean body weight reduction after 13 weekly subcutaneous doses; VENTURE-Oral delivered up to 12.2% at 13 weeks, with up to 80% of subjects reaching at least 10% weight loss. Free Report, Just Released Why Didn't VKTX Make The Top 10 List? 24/7 Wall St has helped investors make money for over two decades, and our top analysts just finished ranking the definitive Top 10 Stocks To Buy Now. Not the ten biggest companies. Not the ten everyone is arguing about. The ten best stocks to buy right now. And VKTX didn't make the cut! The report is free, and you can see why we think each stock is a top investment today. Enter Your Email and See the Ten → A prior 24/7 Wall St. piece argued a Viking catalyst would lift the wider small-cap obesity basket, naming Structure Therapeutics (NASDAQ: GPCR) as the clearest secondary beneficiary. However, Structure traded at $36.56, down 0.7% on the session, extending a 47.4% year-to-date decline — even with oral aleniglipron showing placebo-adjusted mean weight loss of 16.3% at the 180 mg dose at 44 weeks, and Phase 3 trials ACCOMPLISH-1 and ACCOMPLISH-2 already dosing. Eli Lilly (NYSE:LLY) added 1.1% to $1,177.43, in line with recent drift. Lilly's Q2 Mounjaro sales hit $9.94 billion, up 91%, with Zepbound at $4.93 billion, up 46%. Novo Nordisk (NYSE:NVO) slipped 0.7% to $39.54, deepening a 32.5% one-year decline as the company works through list-price cuts of about 50% for Wegovy and 35% for Ozempic effective January 1, 2027. Traders interpreted the move as company-specific validation of a single asset, not a sector-wide signal. Strong data cuts both ways. It hardens Viking's standalone posture, which already includes $502 million in cash at quarter end and both VANQUISH-1 and VANQUISH-2 fully enrolled. It also raises the price of any transaction. A June 24/7 Wall St. listicle argued Viking had the leverage to wait on its own timeline. Today's data strengthens that leverage rather than resolving it. No reporting supports acquisition talks. Lian has said oral VK2735 Phase 3 initiation is expected in Q4 2026, positioning it, in his words, to "potentially become the first orally available dual GLP-1/GIP agonist to reach market." Viking has also flagged an oral maintenance component to follow. Watch the Q4 oral Phase 3 start and the 78-week VANQUISH readouts. If you have cash sitting in your account right now, give this two minutes. After more than two decades of helping investors beat the market, our top analysts at 24/7 Wall St. put together a definitive report on the Top 10 Stocks To Buy Today. And VKTX wasn't one of them. They combed the entire market. It's not 10 ideas, not 10 stocks everyone is talking about, it's what their research points to as the 10 best stocks to buy right now, and it's free. Read more here and >;elm:context_link;itc:0;sec:content-canvas" data-yga="{"yLinkElement":"context_link","yModuleName":"content-canvas","yLinkText":"see which stocks made the list -->"}" class="link ">see which stocks made the list -->> Contact [email protected] for any questions or corrections.

Novo Nordisk (NYSE:NVO) has published results from its phase 3b FRONTIER5 study of investigational treatment denecimig in the Journal of Thrombosis and Haemostasis, reporting safety, laboratory and patient-experience findings in people with haemophilia A. The study examined whether patients could switch directly from emicizumab to denecimig without requiring a washout period or an initial loading dose. The open-label trial enrolled 61 adolescents and adults aged 12 years and older with haemophilia A, including patients with and without inhibitors. Participants were monitored over 26 weeks to assess treatment-emergent adverse events, changes in thrombin generation and their experience using the treatment’s injection device. The trial recorded 107 treatment-emergent adverse events across 43 patients, representing 70.5% of participants. Most events, or 98.1%, were classified as mild to moderate. No thromboembolic events, hypersensitivity reactions or treatment-emergent adverse events leading to treatment discontinuation were reported during the study. The findings provide safety information on switching directly from emicizumab to denecimig, although the open-label design and 26-week observation period limit conclusions about longer-term outcomes. Exploratory laboratory findings showed that mean thrombin peak height increased by 78.8% from baseline across all dosing groups. Thrombin peak height reached levels within the normal range and remained sustained throughout the 26-week study period. Researchers reported no clinical evidence of excessive clotting during the observation period. These laboratory results provide information about denecimig’s effect on thrombin generation but do not, on their own, establish its comparative effectiveness in preventing bleeding. The study also evaluated patients’ experiences with the denecimig injection pen using the Hemophilia Device Handling and Preference Assessment. Among 59 patients who completed the assessment, 98.3% described the injection pen as “easy” or “very easy” to use. A total of 94.9% reported that the pen was easier to use than their previous administration method, while 96.6% preferred it over their prior device. A separate assessment of treatment burden, conducted in 55 patients, showed an average reduction of 4.7 points at week 26 using the Hemophilia Treatment Experience Measure. The average baseline treatment-burden score was 10.5 points. These findings suggest that participants generally reported a more favourable treatment experience after switching, although the study did not include a blinded comparison group. A Biologics License Application for denecimig is currently under review by the US Food and Drug Administration. Novo Nordisk is seeking approval for routine prophylaxis in adult and paediatric patients with haemophilia A, with or without inhibitors. The application covers three dosing schedules: once weekly, once every two weeks and once monthly. Denecimig remains investigational while the FDA reviews the application, and the published FRONTIER5 findings form part of the available clinical evidence concerning its safety and treatment experience. Novo Nordisk stock price

Novo Nordisk stock has fallen sharply over the past three years, yet valuation checks still lean toward the shares looking cheap rather than stretched. With fresh questions around obesity drug competition, patent risk and a changing leadership team, investors are weighing whether that discount is a warning sign or an opportunity. The share price has declined 51.9% over the past three years, which puts a clear spotlight on whether the current level already reflects the main concerns around Novo Nordisk. Progress on obesity treatments and related metabolic drugs, including expansion efforts such as the oral Wegovy application in China, can support confidence in Novo Nordisk’s long term earnings power. At the same time, worries about a patent cliff and pressure from rivals such as Eli Lilly may limit how much investors are willing to pay for that potential. The broader checks lean cheap, with Novo Nordisk screening as undervalued in most valuation metrics and a value score of 5 suggesting the share price sits below what those fundamentals would typically justify. The issue now is whether Novo Nordisk’s recent share price weakness has moved the stock into genuine bargain territory or simply closer to a fair reflection of its risks. Compare Novo Nordisk’s recent slide and value score with a hand picked set of companies that also screen as potentially underpriced using 262 high quality undervalued stocks. P/E is a useful lens for Novo Nordisk because earnings are a key focus for investors in large, mature pharmaceutical groups. On this measure, Novo Nordisk trades on a P/E of 11.4x, which is well below the wider pharmaceuticals industry average of 22.5x and a peer group average of 23.5x. The tailored fair P/E ratio for Novo Nordisk, which reflects its margins, scale and risk profile, is 30.3x. That is higher than where the stock trades today and indicates a discount on this metric. Despite recent concerns around obesity drug competition and a potential patent cliff, the current multiple implies investors are valuing Novo Nordisk at less than half the level suggested by this fair P/E benchmark. On the P/E multiple, Novo Nordisk stock currently appears undervalued relative to both its industry and its own fair ratio. See what the numbers say about this price — find out in our valuation breakdown. Simply Wall St Narratives for Novo Nordisk pick up where the valuation puzzle leaves off and spell out which paths for growth, margins and earnings would make the current share price look either too low or too high. Each narrative ties its number to a clear view on how Novo Nordisk's growth, profitability and risks might evolve, which gives you a reference point that you can revisit as new information comes through. Community views on Novo Nordisk could hardly be further apart, with some investors seeing a rare opportunity and others warning that expectations still look stretched. Bull case: 65% undervalued Read the full Bull Case to see why Novo Nordisk could be undervalued Bear case: roughly fairly valued Read the full Bear Case to see why Novo Nordisk could be overvalued Do you think there's more to the story for Novo Nordisk? Head over to our Community to see what others are saying! On the current numbers, Novo Nordisk screens as undervalued on standard market multiples, with the tailored P/E benchmark pointing to a meaningful gap between price and fundamentals. The broader valuation checks also look supportive, which suggests the discount is not just a single metric quirk. From here, the key question for you is whether the market is overdoing worries about obesity drug competition, patent risk and leadership change, or correctly pricing the chance that Novo Nordisk’s earnings power proves less robust than bulls expect. This article by Simply Wall St is general in nature. We provide commentary based on historical data and analyst forecasts only using an unbiased methodology and our articles are not intended to be financial advice. It does not constitute a recommendation to buy or sell any stock, and does not take account of your objectives, or your financial situation. We aim to bring you long-term focused analysis driven by fundamental data. Note that our analysis may not factor in the latest price-sensitive company announcements or qualitative material. Simply Wall St has no position in any stocks mentioned. Companies discussed in this article include NOVO-B.CO. Have feedback on this article? Concerned about the content? Get in touch with us directly. Alternatively, email [email protected]

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]