Latest news with #AERIFY-1
Yahoo
3 days ago
- Business
- Yahoo
Sanofi (SNY) Stock Down 5% Despite AERIFY-1 Success
Sanofi (NASDAQ:SNY)'s shares fell 5% this week, even as the company announced positive results from its AERIFY-1 trial with Regeneron Pharmaceuticals, marking a significant advance in COPD treatment. This decline comes in contrast to a 2% rise in the broader market, suggesting that investors may be focusing on other company initiatives, such as SNY's recent partnership with Stagecoach Performing Arts to raise awareness about Type 1 diabetes. Despite the short-term drop, Sanofi (NASDAQ:SNY)'s long-term performance remains strong. Over the past five years, the company has delivered a total return of 19.59%, outpacing both the French Pharmaceuticals sector and the broader market, which saw declines of 4% and 4.5% respectively in the past year. Analysts remain optimistic about Sanofi (NASDAQ:SNY)'s future, with the current share price at €95.9 and a consensus target of €117.17, an 18.5% potential upside. The company's Projections for 2028 include revenues of €51.2 billion and earnings of €10.2 billion, supported by innovative drug development and efficient operations. While we acknowledge the potential of SNY as an investment, our conviction lies in the belief that some AI stocks hold greater promise for delivering higher returns and have limited downside risk. If you are looking for an extremely cheap AI stock that is also a major beneficiary of Trump tariffs and onshoring, see our free report on the best short-term AI stock. READ NEXT: and Disclosure: None.
Yahoo
4 days ago
- Business
- Yahoo
REGN Strengthens Obesity Pipeline: Will the Move Revive the Stock?
Regeneron Pharmaceuticals, Inc. REGN is looking to make inroads in the lucrative obesity market. The company recently entered into an in-licensing agreement for an obesity drug with Hansoh Pharmaceuticals Group Company Limited, in a bid to expand its clinical-stage obesity portfolio. The licensing agreement with Hansoh Pharma provides Regeneron with HS-20094, a GLP-1/GIP receptor agonist. Regeneron will acquire exclusive clinical development and commercial rights for HS-20094, a dual GLP-1/GIP receptor agonist, outside the Chinese Mainland, Hong Kong and Macau. Per the terms of the agreement, Regeneron will make an upfront payment of $80 million to Hansoh, with potential additional payments of up to $1.93 billion for achievement of development, regulatory and sales milestones. Any royalties on global net sales in the future (outside the designated territories) would be in the low double digits. HS-20094 has been evaluated in over 1,000 patients and administered as a weekly subcutaneous injection. The candidate has demonstrated promising efficacy and safety clinical data, suggesting a potentially similar profile to the only FDA-approved GLP-1/GIP receptor agonist. The candidate is currently being evaluated in a phase III study in obesity in China, and a phase IIb study in diabetes is ongoing. The in-licensing agreement for an obesity candidate will expand REGN's obesity pipeline, which includes trevogrumab. Regeneron recently announced positive interim results from the ongoing phase II COURAGE study investigating novel combinations of semaglutide (GLP-1 receptor agonist) and trevogrumab (anti-GDF8/anti-myostatin) with or without garetosmab (anti-activin A) for the treatment of obesity. COURAGE was designed to investigate the quality of weight loss in patients with obesity. Results showed that approximately 35% of semaglutide-induced weight loss was due to loss of lean mass, and further demonstrated that combining semaglutide with trevogrumab with or without garetosmab helped preserve lean mass while increasing loss of fat mass. Garetosmab is being evaluated for the treatment of fibrodysplasia ossificans progressive. The successful development of any obesity treatment will be a great boost for the company. We note that REGN has had a rough time so far this year. The stock got hammered last week after REGN and partner Sanofi SNY reported results from two late-stage studies, AERIFY-1 and AERIFY-2, on itepekimab for the treatment of chronic obstructive pulmonary disease (COPD). While the AERIFY-1 study met the primary endpoint, AERIFY-2 did not meet the same. REGN and SNY are currently reviewing the data and plan to discuss the next steps with regulatory authorities. Year to date, REGN's shares have lost 31.7% compared with the industry's 3.2% decline. Image Source: Zacks Investment Research Regeneron's performance in the first quarter was dismal. The plunge in Eylea sales adversely impacted the top line. Eylea sales have been under pressure for some time now due to competition from Roche's Vabysmo. Regeneron Pharmaceuticals, Inc. price-consensus-eps-surprise-chart | Regeneron Pharmaceuticals, Inc. Quote Regeneron has a tough road ahead, as it will take a long time for Eylea HD to contribute significantly to the top line. Apart from Eylea, profits from the sales of asthma drug Dupixent are a primary growth driver for REGN. Regeneron has a collaboration agreement with Sanofi for Dupixent. While the obesity market is lucrative, REGN is a pretty late entrant here. The market is dominated by bigwigs like Novo Nordisk NVO and Eli Lilly LLY. The stupendous success of Novo Nordisk's obesity drug, Wegovy (semaglutide) and Eli Lilly's Zepbound has prompted many companies to join the bandwagon. Buoyed by this success, both Lilly and NVO have taken significant strides in developing their obesity portfolios further. Given the significant market potential of obesity, other players are also striving to grab a chunk of this pie. Regeneron currently has 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 Regeneron Pharmaceuticals, Inc. (REGN) : Free Stock Analysis Report Sanofi (SNY) : 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 Investment Research
Yahoo
31-05-2025
- Business
- Yahoo
Sanofi (ENXTPA:SAN) Reports Positive Phase 3 Results for Itepekimab in COPD Trial
Sanofi announced that its AERIFY-1 trial with Regeneron Pharmaceuticals successfully met its primary endpoint, indicating progress in COPD treatment. Despite this positive news, the company's share price fell 5% over the last week, contrasting with a 2% rise in the broader market. This decline may reflect investors' reactions to other company initiatives, such as its partnership with Stagecoach Performing Arts to raise awareness of autoimmune Type 1 diabetes. These positive developments, although promising, were not enough to counterbalance the broader market's upward trend, contributing weight against Sanofi's price movement. Buy, Hold or Sell Sanofi? View our complete analysis and fair value estimate and you decide. Uncover the next big thing with financially sound penny stocks that balance risk and reward. The recent successful completion of Sanofi's AERIFY-1 trial could have a positive impact on its revenue and earnings forecasts by strengthening its position in the COPD treatment market. However, despite these promising developments, the company's share price experienced a 5% decline in the past week, contrasting with the broader market's 2% rise. This movement might reflect investor reactions to other company initiatives, such as the partnership with Stagecoach Performing Arts, and broader market trends. Looking at a longer-term context, Sanofi's shares have delivered a total return of 19.59% over the past five years. Recent performance has exceeded the French Pharmaceuticals industry and market, which returned 4% and 4.5% declines respectively over the last year. Such outperformance indicates resilience amidst industry challenges and market volatility. Please consider the current share price of €95.9 against the consensus price target of €117.17, indicating a potential upside potential of approximately 18.5%. This price target is based on expectations of revenue reaching €51.2 billion and earnings of €10.2 billion by 2028, trading on a PE ratio of 16.1x. Analysts are assuming that Sanofi will enhance its growth trajectory driven by its innovative treatments and efficient operational strategies. Assess Sanofi's previous results with our detailed historical performance reports. 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 ENXTPA:SAN. This article was originally published by Simply Wall St. Have feedback on this article? Concerned about the content? with us directly. Alternatively, email editorial-team@
Yahoo
30-05-2025
- Business
- Yahoo
Regeneron, Sanofi Stock Falls After Uneven Smoker's Lung Drug Data
Regeneron Pharmaceuticals, Inc. (NASDAQ:REGN) and Sanofi SA (NASDAQ:SNY) on Friday announced results from two Phase 3 trials of itepekimab in chronic obstructive pulmonary disease (COPD) patients. Phase 3 AERIFY-1 trial evaluating itepekimab in adults who were former smokers with inadequately controlled COPD met the primary endpoint of significantly reducing moderate or severe acute exacerbations by 27% compared to placebo at week 52, a clinically meaningful benefit. A second Phase 3 trial, AERIFY-2, did not meet the same primary endpoint. Despite showing some benefit earlier in the trial (at week 24), itepekimab did not achieve a statistically significant reduction in moderate or severe exacerbations at week 52 in the second the trials, patients were randomized to receive itepekimab every two weeks (AERIFY-1: n=375; AERIFY-2: n=326), every four weeks (AERIFY-1: n=377; AERIFY-2: n=303), or placebo (AERIFY-1: n=375; AERIFY-2: n=324), which was added to inhaled triple or double standard-of-care therapy. The primary endpoint for AERIFY-1 and AERIFY-2 was the reduction in the annualized rate of acute moderate or severe COPD exacerbations with itepekimab treatment. The total number of exacerbations was lower than prospectively anticipated, decreasing the power of both trials. Enrollment largely occurred during the global COVID-19 pandemic, which could have contributed to the lower overall exacerbation rates. The safety profile of itepekimab was consistent across dosing regimens, and adverse events (AEs) were generally comparable between treatment and placebo groups. Regeneron and Sanofi will review the data and discuss it with regulatory authorities to evaluate the next steps. Itepekimab is also being evaluated in other respiratory conditions, including chronic rhinosinusitis without nasal polyps, chronic rhinosinusitis with nasal polyps, and non-cystic fibrosis bronchiectasis. In November 2024, Regeneron and Sanofi's Dupixent gained FDA approval for COPD, marking its sixth U.S. indication since its first use for atopic dermatitis seven years ago. This expansion positions Dupixent as the first targeted therapy for COPD, a significant leap in treating this progressive lung condition that impedes breathing due to obstructed airflow. Last Thursday, the U.S. Food and Drug Administration (FDA) approved GSK Plc's (NYSE:GSK) Nucala (mepolizumab) as an add-on maintenance treatment for adult patients with inadequately controlled COPD and an eosinophilic phenotype. Last June, the FDA approved Verona Pharma plc's (NASDAQ:VRNA) Ohtuvayre (ensifentrine) for the maintenance treatment of chronic obstructive pulmonary disease (COPD) in adult patients. Ohtuvayre is the first inhaled product with a novel mechanism of action available for the maintenance treatment of COPD in more than 20 years. In May, Sanofi announced it will invest at least $20 billion in the U.S. through 2030. Research and development, plus U.S. manufacturing, will receive the bulk of the spending. The company also expects higher job creation within the communities where Sanofi and its partners are located, which will help enhance the U.S. supply chain. Earlier in May, Regeneron secured the winning bid in the bankruptcy auction for key assets of 23andMe Holding Co. in a $256 million deal to boost its genetics-based drug discovery efforts. Price Action: REGN stock is down 9.98% at $545, and SNY stock is down 4.57% at $49.96 during the premarket session at last check Friday. Read Next:Photo by Marianne Campolongo via Shutterstock Up Next: Transform your trading with Benzinga Edge's one-of-a-kind market trade ideas and tools. Click now to access unique insights that can set you ahead in today's competitive market. Get the latest stock analysis from Benzinga? REGENERON PHARMACEUTICALS (REGN): Free Stock Analysis Report SANOFI (SNY): Free Stock Analysis Report This article Regeneron, Sanofi Stock Falls After Uneven Smoker's Lung Drug Data originally appeared on © 2025 Benzinga does not provide investment advice. All rights reserved. Sign in to access your portfolio
