Moderna (MRNA) Stock Rallies on FDA Green Light for mRNA Flu Shot

Key Takeaways

Table of Contents

Moderna received FDA clearance for mFlusiva, an mRNA-based seasonal influenza vaccine targeting adults 50 years and above.
Shares of MRNA gained 3.6% to reach $58.30 in premarket trading following the regulatory green light.
This represents Moderna’s second commercially available mRNA vaccine and its fourth product to secure FDA approval.
Financial analysts project significant revenue generation won’t materialize until late 2027.
Among 23 Wall Street analysts tracking MRNA, 18 maintain a “hold” recommendation, with the average price target at $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-based influenza vaccine designed for individuals 50 and older.

Moderna, Inc., MRNA

The regulatory clearance arrived late Wednesday, representing the biotechnology firm’s second commercial mRNA-based vaccine and broadening its respiratory disease portfolio beyond coronavirus vaccines.

Recent trading has been challenging for the stock, which has declined 31.2% during the past 30 days after retreating from its yearly peak of $85.60 reached on July 6. However, MRNA maintains impressive gains of 90.8% year-to-date in 2026 and 104.8% over the trailing twelve-month period.

The path to regulatory approval encountered significant obstacles. In February, regulators issued a “refuse-to-file” notification, rejecting the initial application because Moderna had compared its vaccine against a conventional flu shot instead of Fluzone High-Dose, the FDA’s preferred benchmark for the older adult population.

The agency reversed course within just 48 hours. By June, an FDA advisory panel unanimously voted in favor of recommending mFlusiva for the 50-and-over demographic.

Moderna anticipates mFlusiva will reach the market for the 2026-2027 influenza season, though the company failed to secure contracts during critical pre-season negotiation windows. Consequently, Wall Street analysts are not forecasting substantial revenue contributions from the vaccine until the latter half of 2027.

Analyst Sentiment Remains Tepid

Wall Street’s overall perspective on Moderna continues to be reserved. Among 23 analysts providing coverage, 18 maintain a “hold” stance. Only two assign a “strong buy” rating, while two others rate it a “strong sell.”

The consensus 12-month price objective stands at $55.12, representing a slight markdown from current trading levels.

Short selling activity remains notably high. Approximately 14.3% of the stock’s available float is currently sold short, with a short ratio approaching seven days. This indicates considerable skepticism persists among market participants.

Validating the mRNA Technology Platform

Beyond the immediate flu vaccine market, this approval holds broader strategic implications. It represents progress toward developing a combination Covid-flu vaccine, a product Moderna withdrew from FDA consideration last year after regulators requested additional supporting data.

The approval also serves as official recognition of Moderna’s mRNA platform capabilities, which have 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”—a 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 franchise, including Spikevax and mNEXSPIKE, according to its latest quarterly results.

With mFlusiva now authorized, Moderna counts four FDA-approved products and five approved products worldwide.

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