GSK PLC Stock Price, News & Analysis

The FDA has approved GSK's Nucala (mepolizumab) as an add-on maintenance treatment for adult patients with inadequately controlled COPD and an eosinophilic phenotype. The approval is based on positive results from the MATINEE and METREX phase III trials, which demonstrated significant reduction in moderate/severe exacerbations versus placebo. Nucala is the first approved biologic studied in COPD patients with blood eosinophil count (BEC) starting at ≥150 cells/μL. Nearly 70% of US patients inadequately controlled on inhaled triple therapy have BEC ≥150 cells/μL, representing over a million potential patients. In the MATINEE trial, Nucala showed a reduction in exacerbations requiring emergency department visits or hospitalization, with a rate ratio of 0.65. COPD-related hospitalizations currently cost the US healthcare system approximately $7 billion annually.

GSK has announced the acquisition of efimosfermin, a phase III-ready specialty medicine from Boston Pharmaceuticals, for $1.2 billion upfront with potential additional milestone payments of $800 million. Efimosfermin is being developed to treat steatotic liver disease (SLD), which affects up to 5% of the global population.

The drug is a novel, once-monthly FGF21 analog therapeutic targeting metabolic dysfunction-associated steatohepatitis (MASH) and alcohol-related liver disease (ALD). Phase II trial data showed promising results in reversing liver fibrosis with a manageable tolerability profile. The acquisition aligns with GSK's R&D focus and could potentially lead to the first launch in 2029.

The deal could save the US healthcare system between $40-100 billion over the next two decades through interventions that reduce moderate-to-advanced fibrosis. The treatment offers potential advantages including monthly dosing, improved patient convenience, and the possibility of combination therapy with GSK'990.

GSK has announced a partnership with Lifetime® to produce "Pretty Hurts," an original movie premiering on June 28, 2025, aimed at raising awareness about meningitis among parents of teens. The film, starring Haylie Duff, is part of GSK's Ask2BSure campaign and focuses on educating parents about meningococcal disease risks in teens aged 16-23.

The movie features actresses Alyson Hannigan and Sarah Michelle Gellar as campaign spokespersons. The story follows a mom whose daughter enters a beauty pageant, when meningitis impacts their community. The initiative highlights that while many teens are vaccinated against meningitis serogroups A, C, W, and Y, they may be missing meningitis B vaccination. The film will be available on Lifetime and MyLifetime.com/movies.

GSK's AREXVY vaccine has received a positive recommendation from the Advisory Committee on Immunization Practices (ACIP) for adults aged 50-59 who are at increased risk for severe RSV disease. This expands the previous recommendation from June 2024 for adults aged 60-74 at increased risk and all adults 75+.

The recommendation targets over 13 million adults aged 50-59 with conditions like COPD, asthma, diabetes, heart disease, and those in residential care. RSV causes an estimated 42,000 hospitalizations annually in adults aged 50-64 in the US.

The recommendation follows positive results from a phase III trial evaluating immune response and safety in adults aged 50-59 with underlying medical conditions. AREXVY is indicated for preventing lower respiratory tract disease caused by RSV in individuals 60+ years and those 50-59 years at increased risk.

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.