Key Highlights:
- GSK’s oral antibiotic gepotidacin received priority review by the US FDA for treating uncomplicated urogenital gonorrhoea, with a regulatory decision expected by December 11, 2025.
- The FDA acceptance follows positive Phase III EAGLE-1 trial results, highlighting gepotidacin as a new oral treatment alternative to current injectable therapies for a WHO priority pathogen.
- GSK completed the acquisition of efimosfermin, a promising specialty medicine for steatotic liver disease, expanding its portfolio in critical specialty care areas.
FDA Priority Review of Gepotidacin for Gonorrhoea
GSK submitted a supplemental New Drug Application for gepotidacin, targeting uncomplicated urogenital gonorrhoea in patients aged 12 and above. Supported by robust Phase III clinical data from the EAGLE-1 trial demonstrating superior efficacy versus existing treatments, the FDA has granted priority review to expedite the evaluation process. Approval would enable GSK to address a significant unmet need, as gonorrhoea remains the second most reported STI in the US and is recognized as an urgent health threat by the CDC and WHO.
Expansion in Specialty Medicines with Efimosfermin Acquisition
In a strategic move to strengthen its specialty medicine pipeline, GSK completed the acquisition of efimosfermin alfa from Boston Pharmaceuticals. Efimosfermin represents a potential best-in-class therapy aimed at treating and preventing progression of steatotic liver disease, reflecting GSK’s commitment to advancing therapies for complex metabolic and hepatic conditions.
Robust Financial and Pipeline Outlook Amid Industry Challenges
GSK reported steady revenue growth in the second quarter of 2025 and projects topline sales near the upper range of forecasts for the full year, despite tariff and competitive headwinds. Its HIV, oncology, respiratory, and specialty medicines divisions saw double-digit growth, with a strong focus on pipeline prioritization and developing five significant approvals expected this year, including upcoming decisions on cancer drugs.
Patent Litigation Settlements and Royalty Streams
GSK secured a $370 million upfront settlement plus ongoing royalties from CureVac related to mRNA vaccine patent litigation involving Pfizer and BioNTech. This settlement not only provides substantial immediate financial benefit but also mitigates future patent-related risks, allowing GSK to maintain focus on innovation and growth opportunities.
These developments underscore GSK’s strategic advancement in infectious diseases, specialty care, and pipeline sustainability, positioning it to capitalize on emerging market needs and regulatory catalysts in 2025.
By