Novavax Files 8-K Report

TL;DR

Novavax filed an 8-K, check for updates.

AI Summary

On August 27, 2025, Novavax, Inc. filed an 8-K report detailing various events. The filing includes information on financial statements and exhibits, as well as other events and a Regulation FD Disclosure. Specific financial figures or material events beyond the filing type are not detailed in this summary.

Why It Matters

This 8-K filing indicates Novavax is providing updates to the SEC, which could include material information relevant to investors.

Risk Assessment

Risk Level: low — The filing is a standard 8-K report and does not, on its own, indicate significant new risks.

Key Players & Entities

• NOVAVAX, INC. (company) — Registrant
• August 27, 2025 (date) — Date of Report
• Delaware (jurisdiction) — State of Incorporation
• Gaithersburg, Maryland (location) — Principal Executive Offices

FAQ

Key Financial Figures

• $0.01 — registered Common Stock, Par Value $0.01 per share NVAX The Nasdaq Global Se

Filing Documents

• tm2524511d2_8k.htm (8-K) — 33KB
• tm2524511d2_ex99-1.htm (EX-99.1) — 20KB
• tm2524511d2_ex99-1img001.jpg (GRAPHIC) — 2KB
• 0001104659-25-084049.txt ( ) — 227KB
• nvax-20250827.xsd (EX-101.SCH) — 3KB
• nvax-20250827_lab.xml (EX-101.LAB) — 33KB
• nvax-20250827_pre.xml (EX-101.PRE) — 22KB
• tm2524511d2_8k_htm.xml (XML) — 3KB

01. Regulation FD Information

Item 7.01. Regulation FD Information. On August 27, 2025, Novavax, Inc. ("Novavax" or the "Company") issued a press release announcing the information discussed under Item 8.01 hereof. 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 shall not be deemed "filed" for purposes of Section 18 of the Securities Exchange Act of 1934, as amended (the "Exchange Act"), or incorporated by reference in any filing under the Securities Act of 1933, as amended, or the Exchange Act, except as shall be expressly set forth by specific reference in such a filing.

01. Other Events

Item 8.01. Other Events. On August 27, 2025 the Company announced that the U.S. Food and Drug Administration ("FDA") approved the supplemental Biologics License Application ("BLA") for the Nuvaxovid 2025-2026 formula for the prevention of COVID-19 in adults 65 years and older or individuals 12 years through 64 years of age with at least one underlying condition that puts them at high risk for severe outcomes from COVID-19. The FDA also approved the extension of the shelf life of the Nuvaxovid 2025-2026 formula from three months to six months. In connection with the approval of the supplemental BLA, the FDA is requiring two studies as postmarketing commitments ("PMCs"): (i) to conduct a Phase 3 open-label, single-arm study to evaluate safety and immunogenicity, and (ii) to conduct a Phase 4 observer-blind, placebo-controlled, randomized clinical trial to evaluate post-COVID vaccination syndrome. Cautionary Note Regarding Forward-Looking Statements. This Current Report on Form 8-K contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. We intend such forward-looking statements to be covered by the safe harbor provisions for forward-looking statements contained in Section 27A of the Securities Act of 1933, as amended (the "Securities Act") and Section 21E of the Securities Exchange Act of 1934, as amended (the "Exchange Act"). Any statements in the discussion below and elsewhere in this Current Report about expectations, beliefs, plans, objectives, assumptions, or future events or performance of the Company are not historical facts and are forward-looking statements. Such forward-looking statements include, without limitation, statements regarding the efficacy, safety and intended utilization of the Company's COVID-19 vaccine for the 2025-2025 vaccination season . Generally, forward-looking statements can be identified through the use of words or phrases such as "believe," "may," "could," "will," "would,

Forward-looking statements are neither historical facts nor assurances

Forward-looking statements are neither historical facts nor assurances of future performance. Instead, they are based only on Novavax's current beliefs and expectations about the future of our business, events and trends, and other future conditions. Forward-looking statements involve estimates, assumptions, risks, and uncertainties that could cause actual results or outcomes to differ materially from those expressed or implied in any forward-looking statements, and, therefore, you should not place considerable reliance on any such forward-looking statements. Such risks and uncertainties include, without limitation, challenges or delays related to the requested PMC or in obtaining further regulatory authorization for its COVID-19 vaccine; antigenic drift or shift in the SARS-CoV-2 spike protein, challenges satisfying, alone or together with partners, various safety, efficacy and product characterization requirements, including those related to process qualification and assay validation, necessary to satisfy applicable regulatory authorities; difficulty obtaining scarce raw materials and supplies; resource constraints, including human capital and manufacturing capacity, on the ability of Novavax to pursue planned regulatory pathways; challenges or delays in obtaining regulatory authorization for a JN.1 protein-based COVID-19 vaccine or for future COVID-19 variant strain changes; challenges or delays in clinical trials; manufacturing, distribution or export delays or challenges; Novavax's exclusive dependence on Serum Institute of India Pvt. Ltd. for co-formulation and filling and the impact of any delays or disruptions in their operations on the delivery of customer orders; and other risks and uncertainties identified in Part I, Item 1A "Risk Factors" of our Annual Report on Form 10-K for the year ended December 31, 2024, filed with the Securities and Exchange Commission ("SEC") on February 27, 2025, as updated by the information in Part II, Item 1A "Risk Factors" in

Financial Statements and Exhibits

Financial Statements and Exhibits. (d) Exhibits. Exhibit No. Description 99.1 Press release, Dated August 27, 2025 104 Cover Page Interactive Data File (formatted as Inline XBRL).

SIGNATURES

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: August 27, 2025 By: /s/ Mark J. Casey Name: Mark J. Casey Title: Executive Vice President, Chief Legal Officer and Corporate Secretary

View Full Filing

View this 8-K filing on SEC EDGAR