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BCS

Current Report · Items 7.01, 8.01, 9.01 · 8-K

Moderna, Inc.

MRNANASDAQEQUITYCurrent

Regulation FD Disclosure · Other Events

Item 7.01 Regulation FD Disclosure. On February 10, 2026, Moderna, Inc. (the “Company”) issued a press release regarding the receipt of a Refusal-to-File letter from the U.S. Food and Drug Administration (the “FDA”) for its investigational seasonal influenza vaccine, mRNA-1010. A copy of the press release is furnished as Exhibit 99.1 to this Current Report on Form 8-K.…

Filed Feb 11, 2026Accepted Feb 10, 2026, 6:02 PM ESTCIK 1682852Accession 0001682852-26-000012
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Company context

Moderna is a pioneer and leader in the field of mRNA medicine. Through the advancement of its technology platform, Moderna is reimagining how medicines are made to transform how we treat and prevent diseases. Since its founding, Moderna’s mRNA platform has enabled the development of vaccines and therapeutics across infectious diseases, cancer, rare diseases and more. With a global team and a unique culture, driven by the company’s values and mindsets, Moderna’s mission is to deliver the greatest possible impact to people through mRNA medicines. For more information about Moderna, please visit modernatx.com and connect with us on X, Facebook, Instagram, YouTube and LinkedIn.

Current securities

Recent company filings

  1. Departure of Directors or Certain Officers; Election of Directors; Appointment of Certain Officers; Compensatory Arrangements · Regulation FD DisclosureSep 30, 2026
  2. Entry into a Material Definitive Agreement · Creation of a Direct Financial Obligation or an Obligation under an Off-Balance Sheet Arrangement · Unregistered Sales of Equity Securities · Other EventsSep 1, 2026
  3. SCHEDULE 13G - filed by Capital World Investors regarding Moderna, Inc.Aug 12, 2026
  4. 4 filingAug 7, 2026
  5. 144 filingAug 5, 2026

Registered securities in this filing

MODERNA, INC. · 8-K · Filed 2026-02-11

As filed in this accession. Current/historical status below comes from the governed listing record; the cover itself remains exact to this filing.

Common stock, par value $0.0001 per share

Symbol
MRNA
Exchange
NASDAQ
Classification
COMMON
Status
Current
Filing context

Context: c-1

Dimensions: Not supplied

Accession 000168285226000012 · 1 registered-security cover member

Read the exact SEC filing ↗

Disclosure sections

Items 7.01, 8.01, 9.01

Select an item to read the extracted section. The as-filed document remains the primary evidence.

Item 7.01Item 7.01 - Regulation FD Disclosure
Item 7.01 Regulation FD Disclosure. On February 10, 2026, Moderna, Inc. (the “Company”) issued a press release regarding the receipt of a Refusal-to-File letter from the U.S. Food and Drug Administration (the “FDA”) for its investigational seasonal influenza vaccine, mRNA-1010. A copy of the press release is furnished as Exhibit 99.1 to this Current Report on Form 8-K. The information contained in this Item 7.01, as well as Exhibit 99.1, to this Current Report on Form 8-K is intended to be furnished and shall not be deemed “filed” for purposes of Section 18 of the Securities Exchange Act of 1934, as amended (the “Exchange Act”), or otherwise subject to the liabilities of that section, nor shall it be deemed incorporated by reference in any filing under the Securities Act of 1933, as amended, or the Exchange Act, except as expressly set forth by specific reference in such a filing.
Item 8.01Item 8.01 - Other Events
Item 8.01 Other Events. On February 3, 2026, the FDA's Center for Biologics Evaluation and Research (“CBER”) notified the Company that it will not initiate a review of the biologics license application (“BLA”) for the Company's investigational influenza vaccine, mRNA-1010, and has issued a Refusal-to-File letter.

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