Novavax (NVAX) stock surged 29.27% in pre-market trading on Monday following the long-awaited U.S. Food and Drug Administration (FDA) approval of its COVID-19 vaccine, Nuvaxovid. The approval, which came after substantial back-and-forth with regulators, marks a significant milestone for the biotech firm and triggered a $175 million payment from its partner, Sanofi.

The FDA granted approval for Nuvaxovid with certain conditions, limiting its use to individuals aged 65 and older, as well as those between 12 and 64 who have at least one underlying condition that increases their risk of severe COVID-19. Despite these restrictions, Novavax CEO John Jacobs hailed the approval as a "significant milestone" that solidifies a path for people to access the vaccine.

Analysts reacted positively to the news, with BTIG analyst Thomas Shrader maintaining a Buy rating on Novavax with a price target of $19.00. The approval is seen as a win for Novavax amid FDA changes, enabling the company to gain "full-license" status. While the company missed out on the initial pandemic vaccine windfall due to manufacturing issues and regulatory hurdles, this approval could potentially boost Novavax's position in the evolving COVID-19 vaccine market. The company expects to be ready for commercial delivery of its 2025-2026 vaccine formula in the U.S. this fall, pending the FDA's strain recommendation decision expected on May 22, 2025.