Welcome to our dedicated page for GSK PLC news (Ticker: GSK), a resource for investors and traders seeking the latest updates and insights on GSK PLC stock.
News and regulatory disclosures for GSK plc (GSK) highlight the company’s ongoing activity across medicines, vaccines and strategic collaborations. As a global biopharma company, GSK regularly reports clinical trial milestones, product approvals, public health initiatives and agreements with partners and governments.
Recent news includes multiple regulatory approvals and data readouts in respiratory medicine. GSK has announced approvals for Exdensur (depemokimab) in markets such as Japan for severe asthma and chronic rhinosinusitis with nasal polyps, based on the SWIFT and ANCHOR phase III trials. The company has also reported that Nucala (mepolizumab) was approved in China as an add-on maintenance treatment for adults with COPD characterized by raised blood eosinophils, supported by the MATINEE and METREX studies.
In vaccines, GSK issues updates on Shingrix, including US FDA and European Commission approvals of a prefilled syringe presentation designed to simplify administration, and on its seasonal influenza vaccines FLULAVAL and FLUARIX, which are shipped ahead of each US flu season following FDA lot-release. News about Vaccine Track, GSK’s public data tool for US adult immunization trends, provides additional context on the company’s role in vaccination and public health analytics.
Oncology and specialty medicine updates feature prominently in GSK news. The company has reported US FDA approval of Blenrep in combination regimens for relapsed or refractory multiple myeloma, as well as positive phase III results for bepirovirsen in chronic hepatitis B with plans for global regulatory submissions. Additional releases describe collaborations with partners such as Hengrui Pharma and Summit Therapeutics to develop new respiratory, immunology & inflammation and oncology programs.
Investors and observers following GSK news can expect coverage of clinical trial outcomes, regulatory decisions, pricing and access agreements, and community initiatives such as the Linked by Lupus: Optimal Care Initiative. Bookmarking this page provides a centralized view of GSK’s latest announcements and SEC-reported developments.
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GSK plc (LSE/NYSE: GSK) has announced its agreement to acquire BELLUS Health Inc. (TSX/NASDAQ: BLU) for US$14.75 per share, totaling an approximate equity value of US$2.0 billion. This acquisition aims to strengthen GSK's specialty medicines and respiratory pipeline, particularly through camlipixant, a selective P2X3 antagonist for refractory chronic cough (RCC), currently in phase III clinical trials with a launch anticipated in 2026. The deal is projected to be accretive to adjusted EPS starting from 2027 and has significant sales potential through 2031.
With an estimated 28 million patients suffering from chronic cough globally, this acquisition addresses a substantial unmet medical need, as no approved medicines currently exist for RCC in the US and EU.
Arrowhead Pharmaceuticals (NASDAQ: ARWR) has achieved a $30 million milestone from GSK (LSE/NYSE: GSK) following the initiation of GSK4532990's Phase 2b trial for treating non-alcoholic steatohepatitis (NASH). This investigational RNA interference therapeutic was licensed to GSK in November 2021, with Arrowhead retaining rights for Greater China. The trial, known as HORIZON (NCT05583344), will assess the drug's efficacy and safety in up to 246 participants with pre-cirrhotic NASH. GSK4532990 targets HSD17B13, a gene linked to metabolic protection against NASH.
PathAI has partnered with GSK to conduct the HORIZON Phase 2b clinical trial targeting non-alcoholic steatohepatitis (NASH). This randomized trial will assess the efficacy of GSK4532990 on improving liver histology compared to placebo in patients with advanced fibrosis. PathAI will utilize its AIM-NASH tool for AI-driven histologic evaluation and provide comprehensive pathology services from biopsy analysis to lab services at its Memphis facility. The trial aims to last up to 76 weeks, with treatment lasting up to 52 weeks. This partnership builds on their existing collaboration focusing on drug development in NASH and oncology.
GSK announced promising interim results from the RUBY phase III trial, which evaluates dostarlimab-gxly combined with standard chemotherapy for advanced endometrial cancer. Notably, a 72% reduction in disease progression risk was observed in the dMMR/MSI-H subgroup, while an overall reduction of 36% was reported across all participants. The trial showcased clinically meaningful trends in overall survival and was presented at prestigious medical forums, with regulatory submissions anticipated by mid-2023. These advancements underscore GSK’s commitment to improving treatment options for endometrial cancer.
GSK has launched a national health education campaign called Sideline RSV in partnership with Earvin “Magic” Johnson to raise awareness about the risks of Respiratory Syncytial Virus (RSV) among older adults. The campaign aims to educate this demographic, particularly those with chronic health issues, about RSV's severity, given that approximately 177,000 adults aged 65+ are hospitalized annually in the US due to RSV, leading to an estimated 14,000 deaths. The campaign will include a dedicated website, social media initiatives, and community events to enhance understanding and encourage discussions about RSV and its risks.
GSK plc (LSE/NYSE: GSK) announced that the US FDA granted full approval for Jemperli (dostarlimab-gxly) as a treatment for adult patients with mismatch repair-deficient recurrent or advanced endometrial cancer. This decision is based on long-term data from the GARNET phase I trial, showing an overall response rate of 45.4%. Additionally, 85.9% of patients experienced a response duration of at least 12 months. GSK aims for Jemperli to serve as a core element in its immuno-oncology development programs.
WuXi Biologics has signed a license agreement with GSK granting exclusive rights to one preclinical bi-specific T cell engaging antibody and options for three more. WuXi Biologics will receive an upfront payment of $40 million and could earn up to $1.46 billion from milestone payments. The agreement highlights GSK’s expansion into novel cancer therapies and validates WuXi's proprietary technology platforms. The CEO of WuXi emphasized the significance of this partnership in facilitating GSK's ability to develop potentially life-saving treatments for patients worldwide.
GSK plc (LSE/NYSE:GSK) announced 48-week data from the MOMENTUM phase III clinical trial for momelotinib, showing significant efficacy in myelofibrosis patients previously treated with JAK inhibitors. Key findings include a 97% Total Symptom Score (TSS) response and 90% transfusion independence at week 24, with an associated improvement in overall survival. These results underscore momelotinib's potential as a treatment option to alleviate symptoms of myelofibrosis and reduce transfusion needs. A New Drug Application is currently under FDA and EMA review.