Novavax receives FDA approval for Nuvaxovid COVID-19 vaccine; triggers $175M Sanofi milestone

NOVAVAX INC

FDA approves BLA for Nuvaxovid for COVID-19 in adults 65+ and high-risk individuals 12-64.
Approval triggers $175M milestone payment from Sanofi under May 2024 Collaboration and License Agreement.
FDA requests new Phase 4 postmarketing efficacy trial in 50-64 age group without high-risk conditions; Novavax working with Sanofi on funding.
Novavax reiterates FY2025 R&D+SG&A guidance of $475-525M; projects ~$350M for FY2026 and ~$250M for FY2027.
Expects commercial delivery of 2025-2026 COVID-19 vaccine formula in US this Fall with Sanofi, pending VRBPAC recommendation May 22.

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