Why Is Moderna (MRNA) Stock Down Premarket? FDA Rejects Flu Vaccine Filing

Moderna Inc. (NASDAQ: MRNA) shares plunged 9.30% in premarket trading on Wednesday, February 11, 2026, dropping to $38.09 at 5:34 AM EST following a significant regulatory setback. The biotechnology company announced late Tuesday that the U.S. Food and Drug Administration had issued a refuse-to-file letter for its investigational seasonal influenza vaccine, mRNA-1010, effectively halting the review process before it could begin.

The rejection sent shockwaves through the market, with shares falling as much as 7% in after-hours trading on Tuesday before extending losses further in the premarket session.

FDA Cites Study Design Issues in Rejection

The FDA’s Center for Biologics Evaluation and Research (CBER) issued the refuse-to-file letter, stating that Moderna’s Phase 3 study lacked an “adequate and well-controlled” design. Specifically, the agency criticized Moderna’s decision to test the vaccine against a standard-dose flu shot rather than the “best-available standard of care” recommended for older adults.

The letter, signed by CBER head Vinay Prasad, notably did not cite any specific safety or efficacy concerns with the mRNA-1010 vaccine itself.

Moderna contested the FDA’s reasoning, stating the decision was “inconsistent with previous communications from CBER.” The company noted it had aligned with the agency in April 2024 on the Phase 3 study design and received no objections when the protocol was submitted or when the study launched in September 2024.

Moderna emphasized that the mRNA-1010 vaccine met all of its trial goals in the Phase 3 trial announced in mid-2025 and has been presented as a combination flu shot targeting both influenza and COVID-19.

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Premarket Decline and Market Outlook

At the market close on Tuesday, February 10, Moderna stock stood at $42.00, up a modest 0.11%. However, the regulatory news triggered a sharp reversal, with the stock dropping to $38.09 in premarket trading, representing a 9.30% decline.

The biotech company currently has a market capitalization of $16.41 billion and has experienced significant volatility over the past year, with its 52-week range spanning from $22.28 to $55.20. Analysts had previously projected $117 million in sales for mRNA-1010 in 2026, growing to $931 million by 2030, according to FactSet.

Despite the setback, Moderna stock had been on a strong run recently, rising nearly 148% from a November 21 low to a January 22 high, driven by positive test results for the company’s mRNA-based cancer vaccine developed with Merck.

Moderna has requested a meeting with CBER to discuss the refusal and noted that the flu vaccine has already been accepted for review in Europe, Canada, and Australia, with additional submissions planned for 2026.

Disclaimer: The author does not hold or have a position in any securities discussed in the article. All stock prices were quoted at the time of writing.