Latest news with #Nucala
Globe and Mail
09-07-2025
- Business
- Globe and Mail
GSK's Specialty Medicines Unit on a Strong Footing: Here's Why
GSK plc 's GSK Specialty Medicines segment includes medicines that prevent and treat diseases like HIV, cancer, asthma and immune-inflammation diseases like lupus. Specialty Medicines now represents close to 40% of GSK's sales. The company is witnessing increased sales growth of its Specialty Medicines unit, particularly reflecting successful new launches in Oncology and long-acting HIV medicines. Sales are rising in all areas, HIV, Immunology/Respiratory as well as Oncology. Sales of the Specialty Medicines unit rose 17% in the first quarter of 2025. In the segment, while products like Nucala and Dovato are key top-line drivers, new long-acting HIV medicines, Cabenuva and Apretude, as well as new oncology drugs Jemperli and Ojjaara, are also witnessing strong patient demand and contributing to top-line growth. GSK is also increasing R&D investment in promising new long-acting and specialty medicines in Respiratory, Immunology & Inflammation, Oncology and HIV areas. Blujepa/gepotidacin for treating uncomplicated urinary tract infection ('UTI') was approved in the United States in the first quarter of 2025. Its blockbuster drug Nucala was approved for treating chronic obstructive pulmonary disease or COPD, its fifth indication, in May 2025. Regulatory applications seeking approval of the Blenrep combination for relapsed/refractory multiple myeloma and depemokimab for two indications (chronic rhinosinusitis with nasal polyps or CRSwNP and asthma with type II inflammation) are under review in the United States and some other countries. FDA decisions on all these filings are expected in 2025. Blenrep combinations were approved in the United Kingdom and Japan in April/May 2025. Backed by its existing portfolio of medicines as well as new drugs, GSK expects sales in the Specialty Medicines segment to rise in a low double-digit percentage at CER in 2025, despite the impact from the Inflation Reduction Act or IRA. Specialty Medicines, which now accounts for around 40% of GSK's sales, is expected to be more than 50% of GSK's total revenues by 2031. Competition for GSK's Specialty Medicines In the Specialty Medicines segment, most of GSK's products are up against significant competition from small as well as large pharmaceutical companies like AstraZeneca AZN, Merck MRK, Sanofi SNY, Gilead, Pfizer, J&J and Novartis, among others. In the respiratory market, Advair is facing stiff competition in the COPD and asthma markets from AstraZeneca and Merck's respiratory disease drugs. The launch of AstraZeneca's Fasenra and Sanofi's Dupixent has raised competitive pressure for Nucala. Continued competitive and pricing pressure is hurting sales of GSK's ICS/LABA class of medicines. In HIV, GSK's medicines face competition from Gilead and MRK's drugs. AstraZeneca, Pfizer, Merck and Lilly are GSK's key competitors in the oncology space. GSK's Price Performance, Valuation and Estimates GSK stock has risen 16.3% year to date compared with an increase of 0.3% for the industry. GSK's stock is trading at an attractive valuation relative to the industry. Going by the price/earnings ratio, the company's shares currently trade at 8.34 on a forward 12-month basis, lower than 14.93 for the industry. The stock also trades below its 5-year mean of 10.21. The Zacks Consensus Estimate for earnings has risen from $4.38 to $4.41 per share for 2025 but declined from $4.82 to $4.81 per share for 2026 over the past 60 days. GSK has a Zacks Rank #3 (Hold). You can see the complete list of today's Zacks #1 Rank (Strong Buy) stocks here. 5 Stocks Set to Double Each was handpicked by a Zacks expert as the #1 favorite stock to gain +100% or more in the coming year. While not all picks can be winners, previous recommendations have soared +112%, +171%, +209% and +232%. Most of the stocks in this report are flying under Wall Street radar, which provides a great opportunity to get in on the ground floor. Today, See These 5 Potential Home Runs >> 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 Sanofi (SNY): Free Stock Analysis Report AstraZeneca PLC (AZN): Free Stock Analysis Report GSK PLC Sponsored ADR (GSK): Free Stock Analysis Report Merck & Co., Inc. (MRK): Free Stock Analysis Report
Reuters
13-06-2025
- Health
- Reuters
US FDA extends review of KalVista's swelling disorder drug due to heavy workload
June 13 (Reuters) - The U.S. Food and Drug Administration extended the review of KalVista Pharmaceuticals' (KALV.O), opens new tab drug for a type of hereditary swelling disorder due to heavy workload and limited resources, the company said on Friday. The FDA indicated that it now expects to deliver a decision within four weeks, KalVista said. The original target action date for the decision on the medication, named sebetralstat, was set for June 17 by the regulator. The extension is the latest instance of the FDA missing a deadline following mass layoffs under a major overhaul of federal health agencies under U.S. Secretary of Health and Human Services Robert F. Kennedy Jr. The regulator also missed the target date for GSK's Nucala to treat smoker's lung. KalVista said the FDA has not requested additional data or studies and has not raised any concerns regarding the safety, efficacy or approvability of sebetralstat. The company also said it has addressed all prior information requests in a timely manner and believes the only remaining item under FDA review is the finalization of the packaging insert.
Reuters
30-05-2025
- 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
30-05-2025
- 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
