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Novavax (NASDAQ:NVAX) continued to trade higher on Thursday with a ~20% gain in the premarket after the biotech said that the U.S. Food and Drug Administration (FDA) has accepted to review its marketing application for its COVID-19 vaccine.
Gaithersburg, Maryland-based Novavax (NVAX) which trails its rivals Pfizer (PFE)/ BioNTech (BNTX) and Moderna (MRNA) in the COVID-19 vaccine race has yet to secure full FDA approval for its protein-based shot developed with Sanofi (NASDAQ:SNY).
However, in a regulatory filing Thursday, Novavax (NVAX) said that the FDA has concluded the filing review of its biologics license application for its COVID-19 vaccine, granting April 2025 as the target action date.
As a result, the company said it plans to roll out its updated COVID shot for the 2024–2025 immunization drive under its existing emergency use authorization in the U.S.
The update comes after Novavax (NVAX) said Wednesday that it would launch its latest COVID-19 vaccine in September, subject to regulatory authorization in the U.S.