Quick Summary
- Moderna’s mRNA flu vaccine, mFlusiva, received FDA clearance for use in adults 50 years and older.
- Shares of MRNA advanced 3.6% to $58.30 in premarket trading following the regulatory decision.
- This represents Moderna’s second commercialized mRNA vaccine and its fourth product to gain FDA authorization.
- Wall Street analysts project no substantial revenue from mFlusiva before the latter half of 2027.
- Among 23 analysts tracking MRNA, 18 maintain neutral ratings, with an average price target of $55.12.
Shares of Moderna (MRNA) climbed 3.6% to $58.30 in premarket activity Wednesday following the FDA’s authorization of mFlusiva, the company’s mRNA-powered seasonal influenza vaccine designed for adults 50 and above.
The regulatory clearance was granted late Wednesday, representing the company’s second commercialized mRNA-based vaccine and broadening its respiratory disease product lineup beyond coronavirus vaccines.
The biotech firm has experienced significant volatility recently, with shares plunging 31.2% during the past month following a retreat from its July 6 yearly peak of $85.60. Nevertheless, MRNA maintains impressive year-to-date gains of 90.8% in 2026 and has surged 104.8% across the trailing twelve months.
The path to approval proved challenging. Last February, the FDA delivered a “refuse-to-file” notification, rejecting the initial review application because Moderna had benchmarked the vaccine against a conventional flu shot instead of Fluzone High-Dose, which the FDA recommends as the appropriate comparator for senior populations.
However, the regulatory agency reversed course merely two days afterward. By June, an FDA advisory panel delivered a unanimous recommendation supporting mFlusiva’s authorization for the 50-and-older demographic.
Moderna anticipates mFlusiva will reach the market during the 2026-2027 influenza season, though the company has already missed critical pre-season contracting windows. Consequently, Wall Street researchers aren’t forecasting significant revenue contributions from this vaccine until late 2027 at the earliest.
Analyst Sentiment Remains Tepid
Wall Street’s overall outlook on Moderna remains neutral. Among the 23 analysts providing coverage, 18 maintain “hold” recommendations. Only two assign “strong buy” ratings, while two others issue “strong sell” opinions.
The consensus twelve-month price projection stands at $55.12, representing a modest discount relative to current trading levels.
Short interest remains notably high as well. Approximately 14.3% of the available float is currently sold short, with a short ratio approaching seven days. This indicates considerable bearish sentiment persists among traders.
Platform Credibility Boost
Beyond flu vaccine sales, this approval holds strategic significance. It advances Moderna toward developing a combination Covid-flu vaccine, a product the company withdrew from FDA consideration last year after regulators requested additional supporting data.
The clearance also serves as public confirmation of Moderna’s mRNA technology platform, which has encountered political resistance. In late 2025, HHS Secretary Robert F. Kennedy Jr. ordered the termination of approximately $500 million worth of federal mRNA vaccine agreements, asserting the vaccines triggered “new mutations”āa claim lacking scientific substantiation. Kennedy has publicly stated that mRNA technology “poses more risks than benefits.”
Moderna’s financial performance remains predominantly dependent on its coronavirus vaccine portfolio, including Spikevax and mNEXSPIKE, according to recent quarterly results.
With mFlusiva now authorized, Moderna counts four FDA-approved products and five approved products across global markets.
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