Investing.com -- Novavax , Inc. (NASDAQ: NVAX ) stock soared 12% in response to the U.S. Food and Drug Administration’s approval of the company’s Biologics License Application (BLA) for its COVID-19 vaccine, Nuvaxovid. This approval enables the vaccine’s use for adults over 65 and individuals aged 12 through 64 with certain high-risk conditions, marking a significant expansion of Novavax’s market reach.

The FDA’s green light for Nuvaxovid has triggered a $175 million milestone payment from Sanofi (NASDAQ: SNY ), under a collaboration and license agreement signed in May 2024. Novavax’s President and CEO John C. Jacobs underscored the approval as a critical step toward providing a protein-based, non-mRNA COVID-19 vaccine option for high-risk populations in the United States.

Novavax’s vaccine has been available under Emergency Use Authorization in the U.S. since July 2022 and has garnered full market approvals in several major regions, including the EU, UK, Japan, Canada, Australia, Taiwan, and Singapore. The company is preparing for commercial delivery of the 2025-2026 COVID-19 vaccine formula in the U.S. this fall, in collaboration with Sanofi, pending further FDA recommendations.

Wall Street analysts have noted the significance of this approval, stating, "This clears the way for NVAX supply and brand presence this season, with differentiation as the only non-mRNA option to suit various populations including mRNA-intolerant/hesitant people." This sentiment reflects the potential for Novavax to capture a unique segment of the vaccine market.

In addition to the immediate financial boost from the milestone payment, Novavax is set to receive ongoing tiered royalties from stand-alone COVID-19 vaccine sales in future vaccination seasons. The FDA has also requested a Phase 4 trial to further assess the vaccine’s efficacy and safety in a broader population, which Novavax plans to undertake in partnership with Sanofi.

Investors reacted positively to the news, as the FDA’s approval not only enhances Novavax’s product offering but also solidifies its partnership with Sanofi, a key player in the vaccine market. The company’s stock movement today reflects optimism about its growth prospects and the expanded availability of Nuvaxovid in the U.S. market.

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