GSK PLC Stock Price, News & Analysis

GSK (NYSE:GSK) has announced its sponsorship of the 2025 National Senior Games as part of its Sideline RSV campaign, aimed at educating older adults about respiratory syncytial virus (RSV) risks. The initiative includes a national TV special, "Redefining Aging with Senior Athletes," launching in September 2025, featuring four Senior Games athletes sharing their RSV experiences.

The campaign highlights that RSV affects approximately 177,000 hospitalizations among US adults aged 65+ annually, with an estimated 14,000 deaths. The National Senior Games, scheduled for July 24-August 4 in Des Moines, Iowa, will serve as a platform for GSK to share educational materials and promote conversations about RSV prevention among adults over 50.

GSK (NYSE:GSK) has received FDA approval for a new prefilled syringe presentation of SHINGRIX, its vaccine for preventing shingles. This new format eliminates the need to reconstitute separate vials before administration, streamlining the vaccination process for healthcare professionals.

The approval is based on data showing technical comparability between the new and existing presentations. SHINGRIX remains indicated for adults aged 50 years and older, and those 18 years and older with increased shingles risk due to immunodeficiency. The CDC continues to recommend two doses of the vaccine for these populations.

The prefilled syringe presentation is currently under review by the European Medicines Agency, with filing acceptance received in January 2025.

GSK (NYSE:GSK) has initiated shipments of its seasonal influenza vaccines, FLULAVAL and FLUARIX, for the 2025-26 flu season in the US following FDA approval. Both vaccines will be available in 0.5mL single-dose pre-filled syringes for individuals aged six months and older.

The announcement comes after a severe 2024-25 flu season, which saw 47-82 million flu illnesses, 610,000-1.3 million hospitalizations, and 27,000-130,000 deaths, marking it as the worst flu season in 15 years. The 2025-26 vaccines will target specific virus strains as recommended by the FDA's VRBPAC, including variants of H1N1, H3N2, and B/Victoria lineage.

GSK (NYSE:GSK) has received FDA approval for the Benlysta (belimumab) autoinjector for children aged five and older with active lupus nephritis (LN). This marks a significant milestone as the first-of-its-kind treatment option for at-home administration in pediatric LN patients.

The 200 mg/mL autoinjector, previously approved for pediatric systemic lupus erythematosus (SLE) in 2024, offers an alternative to intravenous infusions. This development is particularly crucial as 30-50% of children with lupus develop LN within one to two years of initial diagnosis. The treatment will be immediately available for pediatric patients and their caregivers.

GSK has launched the Linked by Lupus: Optimal Care Initiative to support individuals with lupus in the US. The company is committing up to $1 million USD in grant funding to support national, state, and local non-profit organizations and community-based groups focused on lupus. The initiative aims to improve earlier diagnosis, enhance awareness of evidence-based treatment options, and advance patient-provider communication. Grant proposals are due by September 1, 2025, and eligible organizations can apply through gskfunding.com. The program complements GSK's existing funding opportunities and will include regular stakeholder meetings to share best practices in addressing health inequities in lupus.

Theravance Biopharma (TBPH) has agreed to sell its remaining royalty interest in Trelegy Ellipta to GSK for $225 million in cash. This deal follows the company's 2022 transaction with Royalty Pharma that generated $1.1 billion upfront. TBPH retains rights to potential milestone payments of up to $150 million from Royalty Pharma based on Trelegy's sales performance in 2025 ($50M for ~$3.41B in sales) and 2026 ($100M for ~$3.51B in sales). The transaction represents the first outcome from the Strategic Review Committee's efforts to maximize shareholder value, with the Board remaining committed to returning excess capital to shareholders. The total potential lifetime value from Trelegy Ellipta monetization efforts could reach $1.525 billion, including previous transactions.

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.