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=834)
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.
Was MFLUSIVA (Influenza Vaccine, mRNA) approved by the FDA?
Yes. The FDA approved the application for MFLUSIVA (Influenza Vaccine, mRNA) on August 5, 2026. The primary source is linked on this page.
Which company is behind MFLUSIVA (Influenza Vaccine, mRNA)?
MFLUSIVA (Influenza Vaccine, mRNA) is a Moderna, Inc. (MRNA) program. The FDA decision came on August 5, 2026; the company's own announcement is linked on this page.
How did MRNA stock trade into the FDA decision?
Measured over the 120 trading days before the decision (T-120 to T-1), MRNA moved +41.2%. That is the recorded price path into this specific event -- historical measurement, not a prediction, and not investment advice.
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