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Moderna Faces FDA Setback on mRNA Flu Vaccine

Story Highlights
  • In February 2026, FDA refused to review Moderna’s mRNA-1010 flu vaccine filing.
  • The refusal, citing trial comparator choice, contrasts prior FDA guidance yet leaves global reviews and 2026 outlook intact.
  • Looking for the best stocks to buy? Follow the recommendations of top-performing analysts.
Moderna Faces FDA Setback on mRNA Flu Vaccine

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The latest update is out from Moderna ( (MRNA) ).

On February 10, 2026, Moderna disclosed that the U.S. Food and Drug Administration’s Center for Biologics Evaluation and Research issued a Refusal-to-File letter on February 3, 2026 for its biologics license application for the investigational seasonal influenza vaccine mRNA-1010, declining to initiate review because the Phase 3 trial used a licensed standard-dose influenza vaccine comparator that regulators now say does not reflect the best-available standard of care. The decision, which did not raise safety or efficacy concerns and diverged from earlier FDA feedback on trial design, leaves Moderna seeking a Type A meeting to clarify a path forward even as mRNA-1010 remains under review in the EU, Canada and Australia based on two Phase 3 studies showing statistical superiority over comparators, and the company maintains that the U.S. setback will not affect its 2026 financial guidance.

The most recent analyst rating on (MRNA) stock is a Sell with a $27.00 price target. To see the full list of analyst forecasts on Moderna stock, see the MRNA Stock Forecast page.

Spark’s Take on MRNA Stock

According to Spark, TipRanks’ AI Analyst, MRNA is a Neutral.

The score is held down primarily by deteriorating financial performance (declining revenue, deep losses, and negative cash flows). Technicals provide a secondary lift due to a strong uptrend and positive momentum, though overbought signals add risk. Valuation is constrained by losses (negative P/E), while the latest earnings call modestly supports the outlook through cost discipline, cash runway, and pipeline/approval progress despite weaker revenue guidance and program discontinuation.

To see Spark’s full report on MRNA stock, click here.

More about Moderna

Moderna, Inc. is a biotechnology company focused on developing medicines using its messenger RNA (mRNA) platform, with a portfolio spanning vaccines and therapeutics for infectious diseases, cancer and rare conditions. The company positions itself as a pioneer in mRNA medicine, leveraging a global team and technology platform to transform how diseases are treated and prevented.

Average Trading Volume: 11,585,357

Technical Sentiment Signal: Buy

Current Market Cap: $16.02B

Find detailed analytics on MRNA stock on TipRanks’ Stock Analysis page.

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