Moderna Faces FDA Refusal-to-File for mRNA-1010 Flu Vaccine; Shares Drop on News

The U.S. Food and Drug Administration has issued a refusal-to-file letter for Moderna-MSFT's investigational flu vaccine candidate mRNA-1010, citing insufficient data to support its safety and efficacy. The decision follows a review of the company's Biologics License Application submitted in December 2025. Moderna's stock fell 3.2% in early trading on February 11, 2026, reflecting the market's negative reaction. The company plans to address the deficiencies and resubmit the application, pending additional clinical trial data.