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's PENMENVY, a groundbreaking 5-in-1 meningococcal vaccine, has received a positive recommendation from the US CDC's Advisory Committee on Immunization Practices (ACIP). The vaccine is recommended for persons over 10 years old as an alternative to separate MenACWY and MenB vaccinations.
The vaccine combines components from GSK's existing vaccines BEXSERO and MENVEO, providing protection against serogroups A, B, C, W, and Y of Neisseria meningitidis in a single dose. The FDA approved PENMENVY on February 14, 2025, for individuals aged 10-25 years.
Currently, MenB is the leading cause of invasive meningococcal disease, yet vaccination rates remain low with less than 13% of 17-year-olds completing the recommended two-dose series. GSK manufactures three of every four MenB doses administered in the US. The vaccine will be available for use in the US from Summer 2025.
GSK has announced the distribution of nearly $2 million in grants to 15 non-profit and community-based organizations through its COiMMUNITY Initiative program. The funding aims to enhance adult immunization rates through improved vaccine education, outreach, and access in the United States.
Key recipients include Sepsis Alliance and Pennsylvania Pharmacists Association, focusing on connecting vaccination to sepsis prevention and promoting year-round vaccination efforts respectively. Other notable awardees include the American Heart Association, American Lung Association, and National Council on Aging.
Additionally, GSK has committed another $2 million for 2025 COiMMUNITY Initiative grants, with proposals being accepted through mid-November 2025 via gskgrants.com.
GSK has received FDA approval for Blujepa (gepotidacin), the first new class of oral antibiotics for uncomplicated urinary tract infections (uUTIs) in nearly 30 years. The drug is approved for female adults and pediatric patients 12 years and older weighing ≥40 kg.
The approval is based on the EAGLE-2 and EAGLE-3 phase III trials, which demonstrated non-inferiority to nitrofurantoin. EAGLE-2 showed 50.6% therapeutic success for Blujepa versus 47.0% for nitrofurantoin, while EAGLE-3 demonstrated superior efficacy with 58.5% success compared to 43.6% for nitrofurantoin.
uUTIs affect up to 16 million women annually in the US, with approximately 30% experiencing recurrent episodes. The most common side effects were gastrointestinal, with diarrhea (16%) and nausea (9%) being the most frequent. Commercial launch is planned for second half of 2025.
GSK has received FDA approval for PENMENVY, a groundbreaking 5-in-1 meningococcal vaccine for individuals aged 10-25 years. The vaccine targets five major serogroups of Neisseria meningitidis (A, B, C, W, and Y) that commonly cause invasive meningococcal disease (IMD).
PENMENVY combines components from GSK's existing vaccines, BEXSERO and MENVEO. The approval was supported by two phase III trials involving over 4,800 participants, demonstrating a safety profile consistent with GSK's licensed meningococcal vaccines.
Currently, MenB is the leading cause of IMD among the target population, with less than 13% receiving the recommended two-dose vaccination series. GSK manufactures three of every four MenB doses administered in the US. The CDC's Advisory Committee on Immunization Practices is expected to vote on recommendations for PENMENVY's use on February 26, 2025.
GSK has announced the acquisition of IDRx, a clinical-stage biopharmaceutical company, for $1 billion upfront plus a potential $150 million regulatory milestone payment. The acquisition centers on IDRX-42, a selective KIT tyrosine kinase inhibitor designed to treat gastrointestinal stromal tumours (GIST).
IDRX-42 has shown promising results in clinical trials, demonstrating activity against all key primary and secondary KIT mutations in GIST. In the StrateGIST 1 phase I/Ib trial, the drug achieved a 29% objective response rate across all patients (n=87) and 53% in second-line patients (n=15), with manageable safety profiles.
The acquisition strengthens GSK's portfolio in gastrointestinal cancers and supports its growth ambitions through 2031. The deal is subject to regulatory clearances under the Hart-Scott-Rodino Act in the US.
GSK announced significant overall survival (OS) results from the DREAMM-7 trial evaluating belantamab mafodotin combination therapy for multiple myeloma. The study showed a 42% reduction in death risk compared to the daratumumab-based treatment.
Key findings include:
- Median follow-up of 39.4 months
- Projected median OS of 84 months for belantamab mafodotin combination vs 51 months for daratumumab combination
- Three-year OS rate of 74% vs 60%
- 2.5-fold improvement in minimal residual disease negativity
The therapy is currently under regulatory review in seven major markets, with priority review status in several countries.
GSK announced new preliminary data for AREXVY, its RSV vaccine, showing promising results in two key populations: adults aged 18-49 with risk factors and immunocompromised adults. A single dose demonstrated robust immune response in at-risk adults 18-49, while immunocompromised adults showed positive results with two doses. The vaccine's potential expansion could benefit over 21 million at-risk adults aged 18-49 in the US alone. Currently approved for adults 60+ in over 50 countries and at-risk adults 50-59 in select regions, these new data support potential broader application. The safety profile remained consistent with previous trials, showing mainly mild, transient effects.
GSK announced new data from the AReSVi-006 phase III trial evaluating the efficacy and safety of AREXVY, its Respiratory Syncytial Virus (RSV) vaccine, in adults aged 60 years and older over three full RSV seasons. The results show:
- Cumulative efficacy over three seasons: 62.9% against RSV-LRTD and 67.4% against severe RSV-LRTD
- Third season efficacy: 48.0% against RSV-LRTD
- Safety and reactogenicity data consistent with previous results
The vaccine demonstrated efficacy against different RSV subtypes, in adults aged 70-79, and those with certain underlying medical conditions. GSK will continue to share data with recommending bodies to inform decisions on immunization schedules and future revaccination.
GSK announced positive topline data from a phase 3 trial evaluating the co-administration of AREXVY (RSV vaccine) and SHINGRIX (shingles vaccine) in adults 50 years and older. The study met its primary endpoint, showing a non-inferior immune response when the vaccines were given together compared to separate administration. Co-administration was well-tolerated with acceptable safety profiles.
Key findings include:
- Comparable immune responses in co-administration and separate administration groups
- Most common adverse events: injection site pain, fatigue, and myalgia
- Similar duration of adverse events across groups
GSK plans to submit these results to support regulatory submissions to the FDA, EMA, and other regulators. The company aims to reduce barriers to adult immunization by potentially decreasing the number of healthcare visits required for vaccination.
GSK plc (LSE/NYSE: GSK) has partnered with Brooke Shields for its THRIVE@50+ campaign, aiming to educate adults 50 and older about their shingles risk and the importance of vaccination. Shields, at 59, directs a short film featuring other celebrities and influencers over 50, discussing the power of aging and health protection. The campaign highlights that 99% of people over 50 are at risk for shingles, with about 1 million cases annually in the US.
The initiative seeks to create a cultural movement around healthy aging, emphasizing that age brings both power and new health considerations. Shields and other participants share their experiences of thriving in their 50s and beyond, while also addressing the importance of protecting one's health from vulnerabilities like shingles.