Novavax Inc. filed SEC Form 8-K: Regulation FD Disclosure, Other Events, Financial Statements and Exhibits
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Item 7.01. Regulation FD Disclosure.
On November 11, 2024, Novavax, Inc. (“Novavax”) issued the press release furnished as Exhibit 99.1 to this Current Report on Form 8-K and incorporated herein by reference.
The information in Item 7.01 is being furnished and shall not be deemed to be “filed” for purposes of Section 18 of the Securities Exchange Act of 1934, as amended, or otherwise subject to the liabilities of that Section and shall not be deemed incorporated by reference into any registration statement or other document filed pursuant to the Securities Act of 1933, as amended, or the Securities Exchange Act of 1934, as amended, except as shall be expressly set forth by specific reference in such filing. In addition, the contents of Novavax’s website are not incorporated by reference into this Current Report on Form 8-K and you should not consider information provided on Novavax’s website to be part of this Current Report on Form 8-K.
Item 8.01. Other Events.
On October 16, 2024, Novavax disclosed that the U.S. Food and Drug Administration (“FDA”) had placed a clinical hold on Novavax’s Investigational New Drug Application (“IND”) for its COVID-19-Influenza Combination and stand-alone influenza vaccine candidates. On November 11, 2024, Novavax announced that the FDA has removed the previously disclosed clinical hold on Novavax’s IND for its COVID-19-Influenza Combination and stand-alone influenza vaccine candidates.
Item 9.01. Financial Statements and Exhibits.
(d) Exhibits.
| Exhibit No. | Description | |
| 99.1 | Press release, dated November 11, 2024 | |
| 104 | Cover Page Interactive Data File (formatted as Inline XBRL). |
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: November 11, 2024 | By: | /s/ Mark J. Casey |
| Name: | Mark J. Casey | |
| Title: | Executive Vice President, Chief Legal Officer and Corporate Secretary | |