Moderna shares rose sharply before the opening bell after the U.S. Food and Drug Administration (FDA) approved its mRNA-based seasonal influenza vaccine, mFLUSIVA, for adults aged 50 and older. The stock climbed 3.37% to $58.15 in pre-market trading, recovering from a 1.29% decline the previous session.
The approval adds a fourth commercial product to Moderna’s U.S. respiratory portfolio, joining Spikevax, mRESVIA, and mNEXSPIKE. The decision followed unanimous support from the FDA’s Vaccines and Related Biological Products Advisory Committee and was backed by a Phase 3 trial involving 40,805 adults across 11 countries. Regulators granted standard approval for those aged 50–64 and accelerated approval for those 65 and older, with a postmarketing study required for the older cohort.
Strategic significance: While analysts do not expect meaningful revenue until the second half of 2027 due to missed contracting cycles, the green light validates Moderna’s mRNA platform beyond COVID‑19. The company is also seeking approvals in the EU, Canada, and Australia, aiming to widen the vaccine’s addressable market. The move comes as Moderna works to reduce dependence on its COVID‑19 franchise, which still drives the majority of revenue.
Wall Street remains cautious. Of 23 analysts, 18 rate MRNA a “hold,” two a “strong buy,” and two a “strong sell,” with a consensus price target of $55.12. Short interest stands at 14.3% of available float. The stock has surged 90.8% year-to-date despite a 31.2% pullback from its July high of $85.60.
