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Novavax Stock Soars 12.64% on FDA Approval Hopes

Mover TrackerWednesday, Apr 23, 2025 9:28 am ET

1min read

Novavax's stock surged 12.64% in pre-market trading on April 23, 2025, driven by positive developments surrounding its COVID-19 vaccine.

Novavax announced that its COVID-19 vaccine is "approvable" based on conversations with the U.S. Food and Drug Administration (FDA). This news comes after the FDA requested additional post-approval data from the company, which Novavax has agreed to provide. The FDA's request for more clinical data is part of its ongoing evaluation process, aiming to ensure the vaccine's safety and efficacy.

Despite the FDA's request for additional data, Novavax remains optimistic about the approval process. The company has stated that it will work with the FDA to address the request promptly and move towards approval as soon as possible. This positive outlook has contributed to the stock's recent gains, as investors see potential for the vaccine's approval and market success.

Novavax's protein-based COVID-19 vaccine offers an alternative to the more widely used mRNA vaccines from Pfizer-BioNTech and Moderna. However, it has faced challenges in gaining traction in the U.S. market. The company's recent developments and positive interactions with the FDA may help to change this dynamic, potentially leading to increased adoption and market share for Novavax's vaccine.

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