Moderna Inc. (NASDAQ:MRNA) stock fell Wednesday as the company faced a setback following a refusal-to-file letter from the U.S. Food and Drug Administration (FDA) regarding its investigational influenza vaccine, mRNA-1010.
“This decision by CBER, which did not identify any safety or efficacy concerns with our product, does not further our shared goal of enhancing America’s leadership in developing innovative medicines,” said Stéphane Bancel, CEO of Moderna.
Regulatory Setback
The FDA’s Center for Biologics Evaluation and Research (CBER) notified Moderna that it would not initiate a review of the biologics license application for mRNA-1010, citing the choice of a standard-dose seasonal influenza vaccine as a comparator as the sole reason for the refusal.
Moderna has requested a Type A meeting with CBER to understand the basis for the refusal and does not expect any impact on its 2026 financial guidance.
Specifically, the letter cited the lack of an “adequate and well-controlled” study with a comparator arm that “does not reflect the best-available standard of care.”
Neither the relevant regulation (Adequate and well-controlled studies) nor the FDA’s guidance for industry on seasonal influenza vaccines contains any reference to the use of a comparator reflecting the “best-available standard of care.” The letter did not identify any specific safety or efficacy concerns regarding mRNA-1010.
Inconsistent Feedback
The letter is inconsistent with previous written communications from CBER to Moderna.
In April 2024, Moderna submitted the Phase 3 study protocol to CBER for review during a pre-Phase 3 consultation. CBER provided written guidance noting that “while we agree it would be acceptable to use a licensed standard dose influenza vaccine as the comparator in your Phase 3 study, we recommend you use a vaccine preferentially recommended for use in older adults by the ACIP for participants >65 years of age in the study.”
ACIP-recommended vaccines include Sanofi SA’s (NASDAQ:SNY) Fluzone HD, Flublok, and Seqirus Inc.’s Fluad
CBER did not raise any objections or clinical hold comments about the adequacy of the Phase 3 trial after the submission of the protocol in April 2024 or at any time before the initiation of the study in September 2024.
In August 2025, following the completion of the Phase 3 efficacy trial in which mRNA-1010 met all agreed-upon pre-specified primary endpoints, Moderna held a pre-submission meeting with CBER.
In its written feedback, CBER requested that supportive analyses on the comparator be included in the submission and indicated that the data would be a “significant issue during review of your BLA.” Moderna provided the additional analyses requested by CBER in its submission, including data from a separate Phase 3 trial (P303 Part C) comparing mRNA-1010 against a licensed high-dose influenza vaccine. At no time in the pre-submission written feedback or meeting did CBER indicate that it would refuse to review the file.
Regulatory Pathway In Other Countries
In addition, mRNA-1010 has been accepted for review in the EU, Canada, and Australia, with potential approvals expected to begin in late 2026 or early 2027.
Moderna plans to submit applications in additional countries throughout 2026.
Moderna Technical Analysis
Currently, Moderna is trading 12.8% below its 20-day simple moving average (SMA) and 7% above its 50-day SMA, indicating some short-term weakness but longer-term strength. Over the past 12 months, shares have increased by 35.77%, and the stock is positioned closer to its 52-week highs than lows, suggesting a relatively strong performance despite recent volatility.
Benzinga Edge Scorecard for Moderna
Momentum: Strong (Score: 89.26) — Stock is outperforming the broader market.
The Verdict: Moderna’s Benzinga Edge signal reveals a classic ‘High-Flyer’ setup. While the Momentum (89.26) confirms the strong trend, the recent regulatory challenges highlight the need for careful monitoring.
MRNA Price Action: Moderna shares were down 8.44% at $38.45 during premarket trading on Wednesday, according to Benzinga Pro data.
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