GSK plc Form 6-K Filing Summary

GSK plc has announced positive Phase II data for its mRNA seasonal influenza vaccine candidate. The vaccine candidate demonstrated superior immune responses compared to existing flu vaccines in both younger and older adults. GSK plans to initiate a Phase III efficacy trial in September 2026. This trial will be the first to evaluate an mRNA flu vaccine targeting both hemagglutinin (HA) and neuraminidase (NA) surface antigens, which are believed to improve protection against the flu virus. The vaccine candidate has received Fast Track designation from the US FDA. The Phase II trial, Flu-028, involved 971 adults and assessed the immunogenicity and safety of the mRNA vaccine. GSK aims to address the significant global burden of seasonal flu, which causes approximately one billion cases and up to 650,000 deaths annually.