Novavax awaits FDA decision on COVID-19 vaccine BLA

GAITHERSBURG, MD – Novavax Inc. (NASDAQ:NVAX), a biotechnology company specializing in the development of vaccines with a market capitalization of nearly $987 million, confirmed today that it is awaiting a decision from the U.S. Food and Drug Administration (FDA) regarding the approval of its COVID-19 vaccine. The company’s stock has experienced significant volatility, declining over 25% year-to-date according to InvestingPro data. The company’s Biologics License Application (BLA) reached its Prescription Drug User Fee Act (PDUFA) date on Tuesday, April 1, 2025, which is the FDA’s action deadline for the application.

In a recent statement, Novavax announced that it had responded to all information requests from the FDA and believes that its BLA is prepared for approval. However, as of today, the company has not received an official decision from the U.S. regulatory agency.

The BLA submission was supported by data from Phase 3 clinical trials, which demonstrated that Novavax’s vaccine is safe and effective in preventing COVID-19. The company expressed confidence in its vaccine, highlighting it as a well-tolerated alternative to mRNA COVID-19 vaccines available in the U.S. market.

Novavax’s statement clarified that the information disclosed in the SEC filing is furnished and not filed, meaning it is not considered official for the purposes of Section 18 of the Securities Exchange Act of 1934, nor is it incorporated by reference into any subsequent filings under the Exchange Act or the Securities Act of 1933.

This news comes as the global community continues to monitor the evolution of the COVID-19 pandemic and the efficacy of vaccines. Novavax, headquartered in Gaithersburg, Maryland, is known for its work in the field of biological products. The company’s stock is traded on the Nasdaq Global Select Market under the ticker symbol NVAX. With annual revenue of $682 million and a strong balance sheet showing more cash than debt, Novavax presents an interesting case for investors. InvestingPro analysis reveals 10+ additional insights about Novavax’s financial health and market position.

Investors and the broader public health community are now awaiting the FDA’s decision, which will have implications for the availability of Novavax’s vaccine in the U.S. market. The information in this article is based on a press release statement. According to InvestingPro’s Fair Value analysis, Novavax appears undervalued at current levels, though investors should note the company’s upcoming earnings report on May 7, 2025, which could impact its market position. For comprehensive analysis, including detailed financial metrics and expert insights, investors can access Novavax’s Pro Research Report, part of InvestingPro’s coverage of over 1,400 US stocks.

In other recent news, Novavax is facing several significant developments impacting its operations and strategic direction. The company has encountered a delay in obtaining full FDA approval for its COVID-19 vaccine, as the FDA has requested additional data beyond the initial deadline. This regulatory hurdle comes at a time when Novavax had anticipated a positive outcome, aligning with its competitors like Pfizer-BioNTech and Moderna (NASDAQ:MRNA), who have already secured full approval. Additionally, Novavax’s contract with the Canadian government has been terminated due to the vaccine not receiving regulatory approval by the specified deadline, leading to the recognition of $576 million as product revenue in early 2025.

Further challenges arise as the U.S. plans to cut financial support for Gavi, the Vaccine Alliance, which could reduce demand for Novavax’s vaccines in developing countries. In a leadership change, Novavax has appointed Margaret McGlynn as the new Chair of the Board following James Young’s retirement, with John Shiver joining as an independent director. These leadership changes are part of the company’s ongoing strategy to expand partnerships and out-license its technology platform. The recent FDA shakeup, marked by the resignation of Dr. Peter Marks, has also affected Novavax, contributing to broader concerns within the biotech sector about potential shifts in regulatory processes.

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