Novavax (NVAX, Financials) shares jumped 17.1% to $7.32 as of 1:10 p.m. ET on Wednesday after the company said it received a request from the U.S. Food and Drug Administration for additional postmarketing clinical data related to its COVID-19 vaccine license application.
The company said the FDA issued a formal information request tied to its Biologics License Application (BLA) and asked for a postmarketing commitment. Novavax said it aims to respond promptly to move the vaccine closer to full regulatory approval.
The request comes after the April 1 Prescription Drug User Fee Act deadline, during which Novavax said it had constructive discussions with the agency.
Novavax stated that while it believes its application is approvable, final approval remains contingent on meeting the FDA's requirements.
The company cautioned that its forward-looking statements—including its expectations for approval—are subject to risks and uncertainties.
