Moderna's mRNA-based flu vaccine candidate MFLUSIVA received a more positive assessment from FDA staff ahead of a June 18 advisory committee meeting, boosting the company's shares by over 10% to around $61 and valuing it at about $24.2 billion. The FDA's Vaccines and Related Biological Products Advisory Committee will discuss the shot's safety and effectiveness for preventing influenza in adults 50 and older, with briefing documents indicating immunological data could support efficacy in those 65 and older and showing better relative efficacy than a standard-dose vaccine in the 50-to-64 age group. Moderna is seeking traditional approval for ages 50 to 64 and accelerated approval for ages 65 and up, with an FDA decision expected by August 5; if authorized, MFLUSIVA would be the first mRNA-based seasonal flu vaccine in the U.S. The review marks a potential turning point for Moderna, which has struggled to prove its mRNA platform can generate recurring revenue beyond Covid vaccines, reporting $389 million in first-quarter revenue and a $1.3 billion net loss, with cash and investments declining to $7.5 billion from $8.1 billion at the end of 2025. While FDA staff noted limitations such as single-season evaluation and exclusion of immunocompromised individuals, a positive outcome could help shift the investment narrative from pandemic-era success to platform credibility, though the company still faces competition, launch risks, and the need for further data in older adults.
Moderna IncFDA staff gave constructive review of Moderna's mRNA flu vaccine ahead of advisory committee vote, boosting shares.