MFLUSIVA (Influenza Vaccine, mRNA), the first mRNA influenza vaccine licensed in the United States, approved for active immunisation against influenza A and B in people 50 years and older (Aug 5 2026).
Run-up into the decision (T-120 → T+5)
Daily close, T-120 (2/6/26) through T+0. Run-up high $81.8 on 7/6/26, low $40.11 on 2/12/26 (T-120 to T-1). FDA decision 8/5/26. Historical price action, not a forecast.
Key facts
FDA decision date2026-08-05
OutcomeApproved
Drug / candidateMFLUSIVA (Influenza Vaccine, mRNA)
IndicationPrevention of influenza in adults 50 years and older
CompanyModerna, Inc.
Market-cap tierLarge
120-day run-up (T-120→T-1)+41.2%
Cohort decision-day move (history)1.0% median (n=827)
Approved on the August 5, 2026 goal date. The approval is split: traditional approval for the 50 and over population, with the indication for people 65 and older granted under accelerated approval, carrying a required post-marketing study comparing relative vaccine efficacy against a high-dose influenza vaccine in US adults 65 and over, due to complete in 2029. This application had previously received a Refusal to File letter on February 3, 2026, which the FDA based solely on the choice of a standard-dose comparator rather than on safety or efficacy; the amended application was accepted two weeks later. An advisory committee voted 9 to 0 in favour for both age groups on June 18, 2026.
Run-up figures are the stock's own daily closing path over the 120 trading days before the decision, from our price history. Cohort move is the historical median absolute decision-day move for this market-cap tier. History, not a prediction.
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