Key Takeaways
- Moderna received FDA authorization for mFlusiva, an mRNA-based seasonal influenza vaccine targeting adults 50 years and older.
- Shares of MRNA gained 3.6% to $58.30 in premarket trading following the regulatory decision.
- The vaccine represents Moderna’s second commercially available mRNA product and its fourth FDA-sanctioned offering in total.
- Wall Street analysts anticipate significant revenue generation won’t occur until the latter half of 2027.
- Among 23 analysts tracking MRNA, 18 maintain a “hold” recommendation, with an average price target of $55.12.
Shares of Moderna (MRNA) climbed 3.6% to $58.30 in premarket activity on Wednesday following the Food and Drug Administration’s authorization of mFlusiva, the company’s mRNA-based seasonal influenza vaccine designed for adults 50 and above.
The regulatory green light arrived late Wednesday evening and represents Moderna’s second mRNA vaccine to reach commercial status, broadening its respiratory disease portfolio beyond coronavirus treatments.
Recent trading has been challenging for the biotech company, with shares declining 31.2% during the previous month after retreating from their July 6 yearly peak of $85.60. Nevertheless, MRNA maintains impressive gains of 90.8% year-to-date in 2026 and has surged 104.8% over the trailing twelve months.
The path to regulatory approval proved rocky. Back in February, the FDA issued a “refuse-to-file” notification, declining to evaluate the submission because Moderna compared the vaccine against a conventional flu shot instead of Fluzone High-Dose, the FDA’s preferred benchmark for senior populations.
The regulatory agency walked back that determination within just 48 hours. By June, an FDA advisory panel voted with unanimous support to recommend mFlusiva for individuals aged 50 and above.
Moderna anticipates mFlusiva availability for the 2026-2027 influenza season, though the organization failed to secure contracts during critical pre-season negotiation windows. Consequently, financial analysts aren’t projecting substantial revenue contributions from this vaccine until late 2027 at the earliest.
Analyst Sentiment Remains Tepid
The overall analytical perspective continues to be neutral. Among the 23 analysts following Moderna, 18 maintain a “hold” stance. Only two assign a “strong buy” rating, while two others rate it as a “strong sell.”
The consensus twelve-month price objective stands at $55.12, representing a modest decrease from current trading levels.
Short interest remains notably high. Approximately 14.3% of the available float has been sold short, accompanied by a short ratio approaching seven days. These metrics indicate considerable doubt persists among market participants.
Validating the mRNA Technology
Beyond influenza prevention alone, this approval holds strategic significance. It represents progress toward a combination Covid-flu vaccine, a product Moderna withdrew from FDA consideration last year after authorities requested additional supporting data.
The authorization also serves as public endorsement of Moderna’s mRNA technological platform, which has encountered political opposition. HHS Secretary Robert F. Kennedy Jr. ordered the termination of approximately $500 million worth of federal mRNA vaccine agreements in late 2025, referencing allegations the vaccines generated “new mutations,” assertions unsupported by scientific research. Kennedy has publicly stated that mRNA technology “poses more risks than benefits.”
Moderna’s financial performance remains predominantly anchored to its Covid-19 product line, including Spikevax and mNEXSPIKE, according to recent quarterly results.
mFlusiva now stands as Moderna’s fourth FDA-authorized product and its fifth approved offering worldwide.
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