Latest news with #GSKplc
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
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. Sign in to access your portfolio
Yahoo
23-05-2025
- Business
- Yahoo
GSK plc (GSK)'s Asthma Drug Gets FDA Nod to Treat ‘Smoker's Lung'
The U.S. Food and Drug Administration has approved GSK plc (NYSE:GSK)'s asthma medication, Nucala, for expanded use in treating a form of chronic obstructive pulmonary disease (COPD), often referred to as 'smoker's lung,' the company announced Thursday. This decision allows Nucala to be used as an add-on therapy for patients with a specific type of COPD. Nucala is a monoclonal antibody that targets interleukin-5, a protein involved in regulating eosinophils—white blood cells that can cause lung inflammation when present in excess. Though the FDA had originally aimed to make a decision by May 7, the approval came two weeks later, continuing a trend of missed deadlines following recent staffing cuts and restructuring within federal health agencies under Secretary of Health and Human Services Robert F. Kennedy Jr. The green light was supported by results from a late-stage clinical trial showing that patients taking Nucala along with standard inhaled therapy experienced 21% fewer disease flare-ups over a 104-week period compared to those given a placebo. In its press release, GSK plc (NYSE:GSK) highlighted that hospitalizations related to COPD are a growing burden on the healthcare system and could soon become the leading cause of medical admissions. Emergency room visits and inpatient treatments already represent a major share of the approximately $7 billion in annual COPD-related healthcare costs in the US. GSK has surged by nearly 15% in 2025 so far. 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 cheapest AI stock. READ MORE: 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
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Business Standard
14-05-2025
- Business
- Business Standard
Here's why GSK Pharma share price was buzzing in trade on Wednesday, May 14
GSK Pharma share price: GlaxoSmithKline Pharmaceuticals (GSK Pharma) shares were in demand on Wednesday, May 14, 2025, with the scrip rallying up to 8.46 per cent to hit an intraday high of Rs 3,026.20 per share. At 11:10 PM, however, the GSK Pharma shares were off highs, and were trading 4.18 per cent higher at Rs 906.85 per share. In comparison, BSE Sensex was trading 0.38 per cent higher at 81,460.24 level. What sparked the up move in GSK Pharma share price? The up move in the GSK Pharma share price came after the company posted a healthy March quarter of financial year 2025 (Q4FY25) results. For the quarter ended March 31, 2025 (Q4FY25), GSK Pharma reported a revenue of Rs 966 crore, a like-to-like growth of 6 per cent. The profit after tax (PAT) for the quarter stood at Rs 260 crore. Meanwhile, the company reported full year revenue of Rs 3,723 crore, a growth of 9 per cent from FY24. The PAT before exceptional items (bei) zoomed 32 per cent to Rs 915 crore, and Ebitda margins expanded 500 basis points (bps) to 31.4 per cent. Bhushan Akshikar, managing director, GlaxoSmithKline Pharmaceuticals, said, 'Our diversified portfolio of General Medicines, Specialty, and Vaccines has shown improved growth due to sustained innovation, enhanced Healthcare Professionals (HCP) engagement and rapid digital acceleration. This has enhanced reach, expanded coverage, and provided a seamless omnichannel experience for our customers. Our key brands, including Augmentin, Calpol, Ceftum, T-Bact, and Trelegy, have played a significant role in driving growth throughout the year. Shingrix is experiencing increased adoption, driven by heightened awareness and our efforts to develop the adult vaccination ecosystem in the country.' 'We remain committed to delivering sustained above-market growth and strong shareholder returns. In FY2025-26, we will continue to focus on our innovative portfolio through the launch of our oncology assets,' Akshikar added. Furthermore, the company revealed that it is on track to launch Zejula (Niraparib), a PARP inhibitor for ovarian cancer and Jemperli (Dostarlimab), an immunotherapy approved for the second-line treatment of endometrial cancer. GSK Pharma dividend, record date The Board has recommended a final dividend of Rs 42 per equity share on face value of Rs 10 each for the year ended March 31, 2025, subject to approval of members at 100th Annual General Meeting (AGM). The Company has fixed Friday, May 30, 2025, as the 'Record Date' for determining entitlement of members to final dividend for FY25. About GSK Pharma GlaxoSmithKline (GSK) Pharmaceuticals is a global healthcare company specialising in vaccines, specialty medicines, and general medicines. It operates under GSK plc, a British multinational pharmaceutical corporation headquartered in London. GSK India, a subsidiary of GSK plc, is a biopharmaceutical company engaged in the development and marketing of vaccines and medicines, with a strong focus on infectious diseases, HIV, oncology, and immunology.\
Yahoo
14-05-2025
- Business
- Yahoo
GSK to acquire efimosfermin, a phase III-ready potential best-in-class specialty medicine to treat and prevent progression of steatotic liver disease (SLD)
Affecting up to 5% of the global population, SLD represents an area of significant unmet medical need with limited treatment options Phase II data show potential of efimosfermin to reverse liver fibrosis, demonstrated in metabolic dysfunction-associated steatohepatitis (a form of SLD) Unique properties offer potential for efimosfermin to be a new standard-of-care Significantly expands GSK's hepatology pipeline aimed at addressing steatotic and viral drivers of liver disease, offering multiple development options and potential first launch in 2029 CAMBRIDGE, Mass., May 14, 2025--(BUSINESS WIRE)--GSK plc (LSE/NYSE: GSK) and Boston Pharmaceuticals, a leading clinical stage biopharmaceutical company developing highly targeted therapies for patients with serious liver diseases, today announced that they have entered into an agreement under which GSK will acquire Boston Pharmaceuticals' lead asset, efimosfermin alfa. Efimosfermin is a phase III-ready, potential best-in-class, investigational specialty medicine to treat and prevent progression of steatotic liver disease (SLD). Under the agreement, GSK will pay $1.2 billion upfront, with potential for additional success-based milestone payments totalling $800 million. Efimosfermin is a novel, once-monthly fibroblast growth factor 21 (FGF21) analog therapeutic in clinical development for the treatment of metabolic dysfunction-associated steatohepatitis (MASH), including cirrhosis, and future development in alcohol-related liver disease (ALD), both forms of SLD. Given efimosfermin's direct antifibrotic mechanism of action and GSK's data-driven insights from work in human genetics and disease phenotyping, it has potential to address more advanced stages of SLD and opportunity in combination with GSK'990, a siRNA therapeutic in development for other subsets of patients with SLD. The acquisition of efimosfermin is highly aligned to GSK's R&D focus on science related to the immune system and is further evidence of the company's intent to build on its deep understanding of fibrosis and auto-inflammation to develop precision interventions that stop and reverse disease progression. SLD represents an area of significant unmet medical need affecting approximately 5% of the global population with limited therapeutic options for patients.1 SLD, including MASH and ALD, is characterised by the accumulation of fat in the liver (steatosis), with associated inflammation and fibrosis. ALD affects about 26 million patients globally, and together with MASH, is the leading cause of liver transplant in the US, representing a significant burden and cost on healthcare utilisation.1,3 Substantial and disproportionate costs are associated with end-stage liver disease. Interventions that reduce moderate-to-advanced fibrosis to prevent progression of cirrhosis, liver cancer, hospitalisations and transplant could save the US healthcare system between $40 - 100 billion over the next two decades.4 Recent data from a phase II trial of efimosfermin, designed to assess the efficacy and safety of a monthly subcutaneous dose in participants with biopsy-confirmed moderate-to-advanced (F2 or F3) MASH, showed that efimosfermin rapidly and significantly reversed liver fibrosis and stopped its progression, with a manageable tolerability profile. These data suggest potentially greater fibrosis improvement compared to that seen with other therapeutic approaches and with benefit expected independent of background glucagon-like peptide-1 (GLP-1) therapy. In addition, efimosfermin could offer triglyceride reduction and improved glycaemic control, important considerations for MASH patients who frequently face cardiometabolic co-morbidities. Efimosfermin's unique properties, including low immunogenicity and an extended half-life, also offer the potential for a monthly dosing regimen and improved patient convenience. Full data from the trial was presented at the American Association for the Study of Liver Diseases (AASLD) Meeting in November 2024.5 Tony Wood, Chief Scientific Officer, GSK said: "The FGF21 class has shown some of the most exciting data in MASH including first-in-disease evidence of cirrhosis reversal, and efimosfermin has the potential to define a new standard-of-care with its monthly dosing and tolerability profile. Efimosfermin will significantly expand our hepatology pipeline and provide us the opportunity to develop a new potential best-in-class medicine with first launch expected in 2029. It complements GSK'990, also in development for ALD and MASH, offering GSK options to develop both monotherapy and potential combinations to improve patient outcomes." Elias Zerhouni MD, Chair of the Board, Boston Pharmaceuticals, said: "I am very proud of today's agreement with GSK, a company I know and admire, and of the outstanding work of the Boston Pharmaceuticals team led by Sophie Kornowski. Notably, this would not have been possible without the impressive, sustained and long-term strategic commitment to leading edge science and biotechnology ventures of the Bertarelli family, which led to the development of our Efimosfermin alfa as a potential best-in-class therapy in its therapeutic field. We are delighted that GSK, a global leader, recognized Efimosfermin's potential to address a growing global public health concern and unmet medical need. Together, we look forward to Efimosfermin alfa's ongoing journey to become a best-in-class treatment for patients with SLD." Sophie Kornowski Pharm D, Chief Executive Officer, Boston Pharmaceuticals said: "Today marks a pivotal moment for Boston Pharmaceuticals and Efimosfermin alfa, as we begin a new chapter with GSK, a global organization with proven expertise in liver disease, and a shared commitment to patients. Our accomplishments were made possible thanks to the dedicated Boston Pharmaceuticals team, who focused on our mission to develop Efimosfermin with a great sense of urgency. I am especially grateful to Ernesto Bertarelli for his unflinching support and the commitment of his expertise over the last few years." The addition of efimosfermin further strengthens GSK's hepatology pipeline of specialty medicines aimed at addressing both viral (chronic hepatitis B) and steatotic (SLD) drivers of fibrotic liver diseases. Financial considerations Under the terms of the agreement, GSK will acquire BP Asset IX, Inc., a subsidiary of Boston Pharmaceuticals, to access efimosfermin. GSK will pay up to $2 billion of total cash consideration, comprising an upfront payment of $1.2 billion and up to $800 million in success-based milestone payments. GSK will also be responsible for success-based milestone payments as well as tiered royalties for efimosfermin owed to Novartis Pharma AG. GSK will account for the transaction as a business combination. This transaction is subject to customary conditions, including applicable regulatory agency clearances under the Hart-Scott-Rodino Act in the US. For GSK, Evercore Partners International LLP is acting as exclusive financial advisor and Cleary Gottlieb Steen & Hamilton LLP as legal counsel. For Boston Pharmaceuticals, Centerview Partners LLC is acting as exclusive financial advisor and Sullivan & Cromwell LLP as legal counsel. About efimosfermin alfa Efimosfermin is an investigational, once-monthly subcutaneous injection of a long-acting variant of FGF21 that is designed to regulate key metabolic pathways to decrease liver fat, ameliorate liver inflammation, and reverse liver fibrosis in patients with MASH. Efimosfermin is currently in trials for moderate to advanced fibrosis, including cirrhosis and is not available for prescription anywhere in the world. About Boston Pharmaceuticals Boston Pharmaceuticals is a clinical-stage biopharmaceutical company that leverages an experienced and committed drug development team to advance a portfolio of highly differentiated therapies that may address important unmet medical needs in serious liver diseases. Boston Pharmaceuticals is a portfolio company of B-Flexion, a private, entrepreneurial investment firm which manages the combined funds and investments associated with the Bertarelli family and also partners with sophisticated capital to meet the shared goal of delivering exceptional value over the generations, while also contributing positively to society. About GSK GSK is a global biopharma company with a purpose to unite science, technology, and talent to get ahead of disease together. Find out more at Cautionary statement regarding forward-looking statements GSK cautions investors that any forward-looking statements or projections made by GSK, including those made in this announcement, are subject to risks and uncertainties that may cause actual results to differ materially from those projected. Such factors include, but are not limited to, those described in the "Risk Factors" section in GSK's Annual Report on Form 20-F for 2024, and GSK's Q1 Results for 2025. Registered in England & Wales:No. 3888792 Registered Office:79 New Oxford StreetLondonWC1A 1DG References1 Global Burden of Disease Study 2017 Cirrhosis collaborators. 20202 Allen et al. Postgraduate Medicine. 2024, Vol 136, No. 3, 229–245.3 Younossi et al. Hepatol Commun. 2023 Dec 22;8(1):e03524 Wallace, Carolyn et al. Journal of Hepatology, Volume 0, Issue 05 Hepatology (2004) Late-Breaking Abstract Supplement p28-30 TLM2024LBA_20241115A.pdf View source version on Contacts GSK enquiries Media:Tim Foley +44 (0) 20 8047 5502 (London)Sarah Clements +44 (0) 20 8047 5502 (London)Kathleen Quinn +1 202 603 5003 (Washington DC)Lyndsay Meyer +1 202 302 4595 (Washington DC) Investor Relations:Constantin Fest +44 (0) 7831 826525 (London)James Dodwell +44 (0) 20 8047 2406 (London)Mick Readey +44 (0) 7990 339653 (London)Steph Mountifield +44 (0) 7796 707505 (London)Jeff McLaughlin +1 215 751 7002 (Philadelphia)Frannie DeFranco +1 215 751 4855 (Philadelphia) Boston Pharma enquiries Media: Sasha Damouni Ellis +1 (646) 240 2311; sasha@ (New York)David Patti +1 (908) 421 5971; dpatti@ (New York) B-Flexion enquiries Media: Blair Hennessy +1 (646) 757 0632; (New York)Emma Prenn-Vasilakis +1 (917) 763 6685; (Boston) Sign in to access your portfolio
