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Why Moderna Stock Is Sinking Today
Why Moderna Stock Is Sinking Today
Nauman Khan
Thu, February 12, 2026 at 2:29 AM GMT+9 1 min read
In this article:
MRNA
-6.08%
This article first appeared on GuruFocus.
Moderna (NASDAQ:MRNA) shares slid about 10% in U.S. premarket trading Wednesday after the U.S. Food and Drug Administration declined to review its application for seasonal flu vaccine mRNA-1010.
The FDA issued a refusal-to-file letter, citing concerns with the clinical trial design rather than safety or efficacy of the vaccine itself.
The agency said the study compared mRNA-1010 to a standard approved flu shot instead of what it described as the best available care. A comparator is the treatment used as a benchmark in clinical trials.
Moderna’s late-stage trial enrolled more than 40,000 participants. The company said results showed the vaccine was 26.6% more effective than the approved flu shot used in the study.
Chief Executive Stephane Bancel said the FDA did not raise safety issues and questioned the agency’s position, noting prior regulatory discussions in 2024 and 2025.
The company has requested a meeting with regulators to discuss next steps, which may include revising the trial design or pursuing another approval pathway.
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