GSK to advance mRNA flu vaccine into Phase III

GSK announced on Sept. 1, 2026, that its mRNA flu vaccine candidate, FLUm3HA.b-3NA, will enter Phase III trials after positive Phase II results. The vaccine targets both hemagglutinin (HA) and neuraminidase (NA) proteins, a strategy not yet approved. GSK aims to differentiate from Moderna's recently approved mRNA flu vaccine, mFlusiva, which targets only HA. The FDA granted Fast Track designation to GSK's candidate in July 2026. Phase II results showed higher immune responses compared to standar

GSK's mRNA flu vaccine candidate, FLUm3HA.b-3NA, advanced to Phase III after showing higher immune responses in Phase II trials. The study involved 971 adults, with the vaccine demonstrating robust responses against influenza strains. GSK plans to begin Phase III trials in September 2026, focusing on the optimized B-strain HA formulation. The candidate uses a dual-antigen approach, targeting both HA and NA, and received FDA Fast Track designation in July 2026.

GSK is preparing to start a Phase 3 trial for its mRNA flu vaccine, which targets both HA and NA proteins. Phase 2 results showed robust immune responses in adults. The vaccine was acquired from CureVac in 2024 for €400 million. Moderna's mRNA flu vaccine, mFLUSIVA, was approved by the FDA in August 2024.

GSK plc will begin Phase III trials for its mRNA flu vaccine after Phase II results showed stronger immune responses. The vaccine targets both HA and NA antigens, aiming to improve protection. The trial, set for September 2026, follows FDA Fast Track designation. GSK's stock closed at $50.25, down 1.12%.

President Trump announced new voluntary drug pricing agreements with nine pharmaceutical companies, including Amgen, Bristol Myers Squibb, and Merck, to lower U.S. prescription drug prices. The deals, part of the TrumpRx platform, aim to align prices with those in other wealthy nations. Companies receive tariff relief in exchange for participation. Critics note limited impact on patient costs and lack of public contract details.

At the American Chemical Society Fall 2026 meeting, 13 new drug candidates were unveiled by various companies, targeting diseases like cancer, lupus, and acne. Presenters included Quanta Therapeutics, AstraZeneca, Novartis, and Pfizer, among others, discussing their drug discovery strategies and clinical trials.