Moderna, Inc. 8-K

What Happened

• Moderna, Inc. (MRNA) reported on Form 8-K (filed Feb 11, 2026) that the FDA’s Center for Biologics Evaluation and Research (CBER) notified the company on February 3, 2026 that it will not initiate review of the biologics license application (BLA) for Moderna’s investigational seasonal influenza vaccine, mRNA-1010, and issued a Refusal-to-File letter. Moderna issued a related press release on February 10, 2026 (furnished as Exhibit 99.1).

Key Details

• FDA action: CBER issued a Refusal-to-File for the mRNA-1010 BLA (notification dated Feb 3, 2026).
• Company disclosure: Moderna furnished a press release dated Feb 10, 2026 and reported the matter on Form 8-K filed Feb 11, 2026.
• Product: The application concerned Moderna’s investigational seasonal influenza vaccine, mRNA-1010.
• Filing note: The 8-K discloses the FDA decision and press release; it does not include detailed reasons from the FDA or financial statements tied to this item.

Why It Matters

• A Refusal-to-File means the FDA will not start its formal review of the BLA, pausing the regulatory pathway for mRNA-1010 and delaying potential approval and commercialization timelines.
• Investors tracking Moderna’s pipeline, future revenue and product launches should view this as a regulatory setback and watch for follow-up disclosures about FDA feedback, planned responses, or resubmission timelines.