Moderna (MRNA) Faces FDA Refusal-to-File Letter

By Chris Stiles • Wednesday, February 11 16:36 • Permanent Link

Moderna, Inc. (NASDAQ: MRNA) has received a refusal-to-file (RTF) letter from the U.S. Food and Drug Administration's (FDA) Center for Biologics Evaluation and Research (CBER) for its investigational seasonal influenza vaccine, mRNA-1010. The RTF letter cited the choice of a licensed standard-dose seasonal influenza vaccine comparator as the sole reason for the refusal to initiate the review of Moderna’s application. This decision is inconsistent with previous communications from CBER to Moderna.

Moderna's mRNA-1010 BLA submission includes two positive phase 3 studies that enrolled a total of 43,808 participants and met all pre-specified primary endpoints. Both phase 3 designs were reviewed by the FDA prior to study initiation.

In August of 2025, following the successful completion of the phase 3 efficacy trial, 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 comparing mRNA-1010 against a licensed high-dose influenza vaccine.

Moderna has requested a type A meeting with CBER to understand the basis for the RTF letter. The company does not expect any impact on its 2026 financial guidance based on the RTF from CBER.

Moderna's CEO, Stéphane Bancel, expressed disappointment with CBER's decision, stating that "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."

Moderna expects the earliest potential approvals for mRNA-1010 to begin in late 2026 or early 2027, subject to ongoing regulatory reviews. The company has also indicated that mRNA-1010 has been accepted for review in the EU, Canada, and Australia, with submissions in additional countries planned for 2026.

Today the company's shares have moved 6.28% to a price of $41.83. Check out the company's full 8-K submission here.

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