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Moderna Stock Slips After FDA Refuses Flu Vaccine Review

Provided by Dow Jones Feb 10, 2026, 11:26:00 PM

By Katherine Hamilton

Moderna shares slid after the Food and Drug Administration refused to consider approving its new flu vaccine.

The stock dropped 7% to $39.00 in after-hours trading, immediately following the announcement. Through the close, shares had gained 32% over the past 12 months.

The FDA sent the biopharmaceutical giant a refusal-to-file letter earlier this month, saying it wouldn't review its application to sell the vaccine.

The regulatory agency said Moderna's study of the vaccine wasn't sufficient because it failed to compare its experimental shot to the best available vaccine on the market.

Moderna said it would ask the FDA for a meeting to discuss the matter.

The FDA didn't flag concerns about safety or effectiveness.

Write to Katherine Hamilton at katherine.hamilton@wsj.com

(END) Dow Jones Newswires

February 10, 2026 18:26 ET (23:26 GMT)

Copyright (c) 2026 Dow Jones & Company, Inc.

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