What Moderna (MRNA)'s Flu Filing Setback and 2025 Loss Mean For Its Regulatory Path
Strong Bearish
-100.0
In February 2026, Moderna reported full-year 2025 revenue of US$1.94 billion and a net loss of US$2.82 billion, while the FDA’s vaccines center issued a refusal-to-file letter declining to review its mRNA-1010 flu vaccine application due to concerns over the chosen trial comparator rather than safety or efficacy.
The FDA’s rejection of Moderna’s flu filing on trial design grounds, despite prior protocol discussions and large Phase 3 studies, introduces fresh regulatory uncertainty for its...
The FDA’s rejection of Moderna’s flu filing on trial design grounds, despite prior protocol discussions and large Phase 3 studies, introduces fresh regulatory uncertainty for its...
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This analysis was generated using Pulse AI, Glideslope's proprietary AI engine designed to interpret market sentiment and economic signals. Results are for informational purposes only and do not constitute financial advice.
