Moderna Says FDA Will Review Flu Shot Submission -- Market Talk

Dow Jones

02/18

0859 ET - Moderna says that the Food and Drug Administration will now review the company's flu-shot submission, marking a pivot from last week when it had refused to review the application. Moderna says it had a meeting with the FDA and proposed a regulatory pathway based on age, seeking full approval for adults 50 to 64 years of age and accelerated approval for adults 65 and older. The FDA has accepted the application for review and set a target review date of Aug. 5. That would make the shot available for U.S. adults 50 years of age and older for the 2026/2027 flu season. Shares jump 8% premarket. (nicholas.miller@wsj.com)

(END) Dow Jones Newswires

February 18, 2026 09:00 ET (14:00 GMT)

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