Latest news with #Nucala
Reuters
3 days ago
- Business
- Reuters
Regeneron shares slide on mixed trial data on smoker's lung drug
May 30 (Reuters) - Regeneron (REGN.O), opens new tab shares fell nearly 13% before the bell on Friday after its experimental drug for patients with a type of lung condition commonly called "smoker's lung" failed a late-stage trial, although it succeeded in another. Regeneron and partner Sanofi ( opens new tab were studying the potential blockbuster drug, itepekimab, as a treatment for chronic obstructive pulmonary disease (COPD) in adult former smokers. The condition has limited treatment options and the drug was expected to target a broader patient population compared to Regeneron and Sanofi's blockbuster Dupixent, which is also approved for the condition. But after Friday's data, Barclays analyst Emily Field said Dupixent is likely to remain the first choice for doctors. GSK's (GSK.L), opens new tab Nucala, approved recently for COPD, is also a blockbuster drug. Nearly 16 million U.S. adults suffer from COPD, according to government data. Regeneron's shares, which have already fallen 15% this year, were trading at $530 in premarket trading. The company has a market capitalization of $65.36 billion. The company's itepekimab showed a significant reduction in exacerbations or flare-ups in the condition by 27% compared to placebo at 52 weeks in a 1,127-patient study. But the second study - which had enrolled fewer former smokers compared to the first - did not meet its goal although a benefit was seen earlier in the trial. The experimental drug, which is being jointly developed by Regeneron and Sanofi, binds to and inhibits interleukin-33, a type of protein that causes inflammation in COPD. COPD is a common lung disease causing restricted airflow and breathing problems. It typically affects smokers, but can also be caused by pollutants. Sanofi and Regeneron are assessing the data and will discuss with regulatory authorities to evaluate their next steps, the companies said. Regeneron's price to earnings ratio, a common benchmark for valuing stocks, was 16.15, compared with 13.62 for Gilead (GILD.O), opens new tab and 7.29 for Bristol Myers Squibb (BMY.N), opens new tab.
Yahoo
3 days ago
- Business
- Yahoo
Regeneron shares slide on mixed trial data on smoker's lung drug
(Reuters) -Regeneron shares fell nearly 13% before the bell on Friday after its experimental drug for patients with a type of lung condition commonly called "smoker's lung" failed a late-stage trial, although it succeeded in another. Regeneron and partner Sanofi were studying the potential blockbuster drug, itepekimab, as a treatment for chronic obstructive pulmonary disease (COPD) in adult former smokers. The condition has limited treatment options and the drug was expected to target a broader patient population compared to Regeneron and Sanofi's blockbuster Dupixent, which is also approved for the condition. But after Friday's data, Barclays analyst Emily Field said Dupixent is likely to remain the first choice for doctors. GSK's Nucala, approved recently for COPD, is also a blockbuster drug. Nearly 16 million U.S. adults suffer from COPD, according to government data. Regeneron's shares, which have already fallen 15% this year, were trading at $530 in premarket trading. The company has a market capitalization of $65.36 billion. The company's itepekimab showed a significant reduction in exacerbations or flare-ups in the condition by 27% compared to placebo at 52 weeks in a 1,127-patient study. But the second study - which had enrolled fewer former smokers compared to the first - did not meet its goal although a benefit was seen earlier in the trial. The experimental drug, which is being jointly developed by Regeneron and Sanofi, binds to and inhibits interleukin-33, a type of protein that causes inflammation in COPD. COPD is a common lung disease causing restricted airflow and breathing problems. It typically affects smokers, but can also be caused by pollutants. Sanofi and Regeneron are assessing the data and will discuss with regulatory authorities to evaluate their next steps, the companies said. Regeneron's price to earnings ratio, a common benchmark for valuing stocks, was 16.15, compared with 13.62 for Gilead and 7.29 for Bristol Myers Squibb. Error in retrieving data Sign in to access your portfolio Error in retrieving data Error in retrieving data Error in retrieving data Error in retrieving data
Yahoo
24-05-2025
- Business
- Yahoo
GSK plc (GSK) Stock Rises as FDA Approves Nucala for COPD, CHMP Backs Blenrep for Cancer Treatment
GSK plc (NYSE:GSK) has strengthened its market outlook following major regulatory milestones. The U.S. FDA's recent approval of Nucala for chronic obstructive pulmonary disease (COPD) and a positive recommendation from the Committee for Medicinal Products for Human Use (CHMP) for Blenrep in multiple myeloma signal significant expansion in GSK's high-demand therapeutic portfolio. These advances are expected to boost the company's Specialty Medicines segment, which already reported a robust 17% sales increase, and are central to analyst projections of 4.6% annual revenue growth over the next three years. Despite broader market volatility and renewed trade tensions, GSK plc (NYSE:GSK) shares have climbed 4.9% in the past month, outperforming a market that saw a 2.5% weekly decline. This surge reflects growing investor confidence in GSK's innovation pipeline and future earnings potential. The company's fair value is estimated at £16.72 per share, suggesting an 18.6% upside from current levels. Over five years, GSK plc (NYSE:GSK) delivered a 5.42% total shareholder return, underscoring steady long-term growth amid industry challenges. While the stock underperformed the UK Pharmaceuticals sector over the past year, recent product approvals could reinforce GSK's competitive position and drive further gains. While we acknowledge the potential of GSK to grow, 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 AI stock that is more promising than GSK and that has 100x upside potential, check out our report about this READ NEXT: and Disclosure: None. Error in retrieving data Sign in to access your portfolio Error in retrieving data Error in retrieving data Error in retrieving data Error in retrieving data
WebMD
23-05-2025
- Health
- WebMD
FDA OKs Nucala for Hard-to-Treat COPD
May 23, 2025 -- The FDA has approved the asthma drug Nucala for adults with chronic obstructive pulmonary disease (COPD). It is the second biologic therapy approved for the condition, following the approval of Dupixent for COPD in September. The approval is the fifth time the drug has been cleared for use and allows it to be used as an add-on treatment for eosinophilic COPD. This form of the disease involves inflammation and higher levels of certain white blood cells (eosinophils) and tends to lead to more frequent flare-ups and hospitalizations. COPD is a chronic lung condition that gets worse over time, making breathing difficult as inflammation narrows the airways. It affects more than 390 million people and is the third leading cause of death worldwide. With eosinophilic COPD, even a moderate blood eosinophil count of 150 cells/µL — or 150 eosinophils per microliter of blood — is enough to raise the risk of flare-ups, often leading to hospital visits and permanent lung damage. About 70% of COPD patients struggle with flare-ups despite using inhalers, especially when eosinophil levels exceed this threshold. Nucala (generic name mepolizumab) works alongside inhalers. 'COPD isn't just a disease, it's a relentless cycle,' said Jean Wright, MD, chief executive officer of the COPD Foundation, in a news release. 'For individuals living with COPD, managing exacerbations is an ongoing challenge, even with inhaled maintenance therapy. Biologics like mepolizumab are providing renewed optimism for those affected by COPD.' According to the release — issued by GSK, the drug's maker — the approval was based on two clinical trials involving more than 1,600 patients. In the trials, Nucala significantly reduced the number of flare-ups in patients whose COPD wasn't well controlled with inhalers. Those who received Nucala injections every four weeks had 18% to 21% fewer episodes of moderate to severe exacerbations than those given a placebo. First approved in 2015, Nucala is a monoclonal antibody, meaning it recruits your body's immune system to fight disease. It helps reduce inflammation by targeting a protein called interleukin-5 (IL5), a major contributor to COPD-related lung inflammation. The drug is given as an injection by a health care provider and is already approved in the U.S. to treat four other conditions related to IL-5. The most common side effects include back pain, diarrhea, and cough, according to GSK.
Yahoo
23-05-2025
- Business
- Yahoo
GSK (LSE:GSK) Secures FDA Approval For COPD Treatment, Eyes European Nod For Blenrep
GSK recently received FDA approval for Nucala for COPD treatment, potentially enhancing its market presence. Meanwhile, the Committee for Medicinal Products for Human Use recommended Blenrep for multiple myeloma, adding momentum to the company's oncology portfolio. Despite broader market volatility driven by renewed trade tensions sparked by President Trump, GSK's shares rose 4.9% over the last month. This increase, amid a market experiencing a 2.5% weekly drop, suggests that the company's positive product news may have overshadowed broader market concerns, highlighting investor confidence in GSK's future earnings potential. You should learn about the 4 risks we've spotted with GSK. Trump's oil boom is here — pipelines are primed to profit. Discover the 22 US stocks riding the wave. The recent FDA approval for GSK's Nucala in COPD treatment and the positive recommendation for Blenrep could significantly enhance the company's revenue and earnings forecasts by expanding its product offerings in high-demand therapeutic areas. The approval is projected to strengthen its Specialty Medicines segment, which already experienced a 17% sales increase. The company's ongoing innovation and pipeline launches are central to analysts' expectations of 4.6% annual revenue growth over the next three years. These developments might improve investor sentiment, as reflected in the company's fair value estimation of £16.72 per share, indicating an 18.6% potential upside from the current share price of £13.6. Over a five-year period, GSK experienced a total shareholder return of 5.42%, highlighting steady albeit modest growth in a volatile market environment. In the past year, however, GSK's stock underperformed compared to the UK Pharmaceuticals industry, which recorded a 13% decline, and the broader UK market with a 2.2% increase. Despite short-term challenges, the company's long-term performance and the potential impact of recent product approvals could further consolidate its market position. The fair valuation underscores the need for investors to assess how GSK's operational enhancements will influence its growth trajectory amid competitive pressures and sector-specific risks. Upon reviewing our latest valuation report, GSK's share price might be too pessimistic. 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 LSE:GSK. 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@ Sign in to access your portfolio
