UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
FORM
CURRENT REPORT
PURSUANT TO SECTION 13 OR 15(d)
OF THE SECURITIES EXCHANGE ACT OF 1934
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Item 7.01. Regulation FD Disclosure.
On April 2, 2025, Novavax, Inc. (the “Company”) issued the following statement:
Novavax can confirm that April 1, 2025, was the U.S. Food and Drug Administration (“FDA”)’s Prescription Drug User Fee Act date for our Biologics License Application (“BLA”) seeking the approval of our COVID-19 Vaccine. As of Tuesday, April 1, we had responded to all of the FDA’s information requests and we believe that our BLA is ready for approval. As of today, we continue to wait on action from the agency and have not yet received an official decision from the U.S. FDA.
Our application included robust Phase 3 clinical trial data that showed our vaccine is safe and effective for the prevention of COVID-19. We are confident our well-tolerated vaccine represents an attractive alternative to mRNA COVID-19 vaccines for the U.S.
The information in Item 7.01 of this Current Report on Form 8-K, is being 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 Exchange Act or the Securities Act of 1933, as amended, except as expressly set forth by specific reference in such a filing.
SIGNATURES
Pursuant to the requirements of the Securities Exchange Act of 1934, the Registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.
| Novavax, Inc. | ||
| Date: April 2, 2025 | By: | /s/ Mark J. Casey |
| Name: | Mark J. Casey | |
| Title: | Executive Vice President, Chief Legal Officer and Corporate Secretary | |