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Investing.com -- Novavax (NASDAQ:NVAX) shares surged 13% following the biotechnology company’s optimism about its Biologics License Application (BLA) with the U.S. Food and Drug Administration (FDA). The company’s confidence stems from recent conversations with the FDA, suggesting that its application for a novel vaccine is approvable.
On April 23, 2025, Novavax issued a statement expressing belief in the approvability of its BLA based on interactions with the FDA up to the current date. The company has also received a formal request from the FDA for additional clinical data as a post marketing commitment (PMC). Novavax has committed to working swiftly with the FDA to address this request and aims for approval as soon as possible.
This positive development comes after Novavax’s stock experienced a decline due to comments from RFK Jr., who suggested that the delay in the vaccine’s approval was not due to a lack of personnel at the FDA, but rather because Novavax produces a single antigen vaccine. The recent uptick in Novavax’s stock price reflects investor confidence in the company’s ability to navigate the regulatory process and bring its vaccine to market.
Investors are reacting to the latest communications with the FDA, which indicate a path forward for the company’s vaccine candidate.
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