Moderna Stock Alert: - Kehoe Law Firm, P.C. Investigating Securities Claims on Behalf of Moderna Investors - MRNA

On February 10, 2026, Moderna ". . . announced the U.S. Food and Drug Administration's (FDA) Center for Biologics Evaluation and Research (CBER) has notified the Company that it will not initiate a review of the biologics license application (BLA) for its investigational influenza vaccine, mRNA-1010, and has issued a Refusal-to-File (RTF) letter."

The Company reported that "CBER's RTF letter . . . identified 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. 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.'"

On this news, Moderna's stock was down more than 10% during intraday trading on February 11, 2026.

Additional information is available at https://kehoelawfirm.com/moderna-mrna/.

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