Moderna receives FDA Refusal-to-File for flu vaccine mRNA-1010; no impact on 2026 guidance

Moderna, Inc.

FDA CBER refused to review BLA for mRNA-1010 citing comparator choice, not safety/efficacy.
Moderna states RTF letter contradicts prior written feedback from pre-Phase 3 and pre-submission meetings.
Moderna has requested a Type A meeting with FDA to discuss path forward.
mRNA-1010 accepted for review in EU, Canada, Australia; earliest approval late 2026/early 2027.
Company reaffirms no change to 2026 financial guidance despite RTF.

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