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.
GSK announced that the US FDA has expanded the approval of Jemperli (dostarlimab-gxly) in combination with chemotherapy for treating adult patients with primary advanced or recurrent endometrial cancer. This approval now includes MMRp/MSS tumors, representing 70-75% of endometrial cancer cases. The decision is based on the RUBY phase III trial results, which showed a 31% reduction in the risk of death compared to chemotherapy alone. At the 2.5-year mark, 61% of patients in the Jemperli plus chemotherapy group were alive compared to 49% in the chemotherapy-only group. The median overall survival improved by 16.4 months with Jemperli plus chemotherapy. This makes Jemperli the first and only immuno-oncology-based treatment to demonstrate an overall survival benefit in this patient population.
GSK has initiated the shipment of its trivalent influenza vaccines, FLULAVAL and FLUARIX, for the 2024-25 flu season across the US. This follows the FDA's licensing and lot-release approval, aligning with WHO's recommendation for the removal of the B/Yamagata strain. The vaccines will contain strains A/Victoria/4897/2022 (H1N1)pdm09-like virus, A/Thailand/8/2022 (H3N2)-like virus, and B/Austria/1359417/2021 (B/Victoria lineage)-like virus. GSK anticipates distributing over 36 million doses and the vaccines are suitable for individuals aged six months and older. The CDC underscores annual flu vaccination as the optimal protection against influenza, with vaccination ideally completed by the end of October.
The US FDA has approved GSK's AREXVY for preventing RSV lower respiratory tract disease (LRTD) in adults aged 50-59 at increased risk. Previously, the vaccine was only approved for those 60+. Over 13 million US adults aged 50-59 have medical conditions that heighten their risk of severe RSV outcomes, such as COPD, asthma, heart failure, and diabetes. A phase III trial supported this approval, showing positive immune responses and safety in the targeted age group. GSK has also submitted regulatory filings in Europe, Japan, and other regions. Data from ongoing trials in adults 18+ are expected in H2 2024.
GSK announced updated results from a phase II study evaluating Jemperli (dostarlimab-gxly) for treating mismatch repair deficient (dMMR) locally advanced rectal cancer. The trial, conducted with Memorial Sloan Kettering Cancer Center, showed a 100% clinical complete response (cCR) in 42 patients. The results, presented at the 2024 ASCO Annual Meeting, indicate no evidence of disease with a median follow-up of 26.3 months for the first 24 evaluated patients. The study highlights the potential of Jemperli as a non-surgical, first-line treatment option, addressing the negative impacts of current standard treatments. GSK is also advancing further studies, including AZUR-1 and AZUR-2 clinical trials, to evaluate Jemperli in various colorectal cancers.
GSK announced positive interim results from the DREAMM-8 phase III trial, showing that the combination of belantamab mafodotin, pomalidomide, and dexamethasone (PomDex) significantly reduced the risk of disease progression or death by nearly 50% compared to a standard of care combination in relapsed/refractory multiple myeloma. The median progression-free survival (PFS) was not yet reached at a 21.8-month median follow-up for the belantamab mafodotin combination versus 12.7 months for the bortezomib combination. Additionally, the PFS benefit was observed across all pre-specified subgroups, including high-risk patients. Although a positive trend in overall survival (OS) was noted, it was not statistically significant at this interim analysis. Safety profiles were consistent with known profiles of the individual agents, and common adverse events included neutropenia and ocular symptoms. These findings, presented at the 2024 ASCO Annual Meeting and published in the NEJM, support the potential of belantamab mafodotin in redefining treatment for multiple myeloma at or after first relapse.
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