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
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.
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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.