Form 8-K · Current Report · Filed 2026-02-10
Moderna's BLA for Seasonal Influenza Vaccine mRNA-1010 Refused by FDA
Moderna, Inc. announced on February 10, 2026, that the U.S. Food and Drug Administration (FDA) refused to file its Biologics License Application (BLA) for the investigational seasonal influenza vaccine, mRNA-1010. The FDA cited the choice of a licensed standard-dose seasonal influenza vaccine comparator as the reason for the refusal. Moderna had exercised a Priority Review Voucher to facilitate a timely review of the application. Moderna has requested a Type A meeting to understand the path forward and does not expect any impact on its 2026 financial guidance.
- Filer
- Moderna Inc. MRNA · NASDAQ
- Filed
- Accession
- 0001682852-26-000012
- CIK
- 0001682852
- Signal
- High impactHealthcare
- Source
- Official filing on sec.gov ↗
Items reported
Reported Item
Market reaction
Close before filing
$41.95
Next session
-3.4%
Since filing
+30.7%
Latest close
$54.82
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About Moderna Inc.
Moderna Inc. is a biotechnology company focused on developing transformative medicines based on messenger RNA (mRNA) technology. Its primary function is to research and produce a broad spectrum of vaccines and therapeutics by leveraging its proprietary mRNA technology platform. Moderna is notably recognized for its pivotal role in the healthcare and pharmaceutical sector, particularly due to its development of one of the first COVID-19 vaccines to receive emergency use authorization. The company’s pipeline extends beyond infectious diseases, targeting therapeutic areas such as oncology, cardiovascular diseases, and rare genetic disorders. Headquartered in Cambridge, Massachusetts, Moderna takes a leading position in the biotechnology industry through its innovative approach to drug development, emphasizing rapid advancement from concept to clinical application. The company plays a crucial role in addressing global health challenges through its cutting-edge mRNA-based solutions.
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