---
schema_version: "secwatch.filing_event.v1"
accession: "0001682852-26-000012"
form_type: "8-K"
ticker: "MRNA"
cik: "0001682852"
company_name: "Moderna, Inc."
filed_at: "2026-02-11T23:59:59+00:00"
generated_at: "2026-05-16T03:20:08.162584+00:00"
event_type: "regulatory"
sentiment: "negative"
materiality_score: 0.75
calibrated_materiality_score: 0.75
confidence: "high"
source: SEC EDGAR
---

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

## Summary
- 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.

## SEC filing metadata
- accession: 0001682852-26-000012
- form_type: 8-K
- ticker: MRNA
- cik: 0001682852
- company_name: Moderna, Inc.
- filed_at: 2026-02-11T23:59:59+00:00
- event_type: regulatory
- sentiment: negative
- materiality_score: 0.75
- calibrated_materiality_score: 0.75
- confidence: high
- sec_items: 7.01, 8.01, 9.01
- EDGAR index: https://www.sec.gov/Archives/edgar/data/1682852/000168285226000012/0001682852-26-000012-index.htm
- EDGAR primary document: https://www.sec.gov/Archives/edgar/data/1682852/000168285226000012/mrna-20260203.htm

## Machine-readable alternates
- HTML: https://secwatch.observer/filing/0001682852-26-000012
- JSON: https://secwatch.observer/filing/0001682852-26-000012.json
- Plain text: https://secwatch.observer/filing/0001682852-26-000012.txt

This AI-assisted summary is a reading aid. Review the linked SEC EDGAR filing before relying on any specific claim.