Novavax completed the transfer of the U.S. marketing authorization for its COVID‑19 vaccine, Nuvaxovid, to Sanofi. The transfer, finalized on 4 November 2025, enabled Sanofi to assume full responsibility for commercial and regulatory activities in the United States and triggered a $25 million milestone payment to Novavax.
The $25 million payment is the second of two $25 million milestone payments linked to the transfer of marketing authorizations. The first payment was received in October 2025 for the European Union transfer. Combined, the two payments bring Novavax’s milestone revenue from the Sanofi partnership to $225 million year‑to‑date. The milestone payments are part of a broader collaboration and license agreement announced on 10 May 2024, which also includes a $500 million upfront payment and up to $700 million in additional development, regulatory, and launch milestones.
Nuvaxovid received U.S. FDA approval on 16 May 2025, but the approval is limited to individuals aged 65 and older and those aged 12‑64 with at least one high‑risk underlying condition. The 2025‑2026 formulation was approved on 27 August 2025. The transfer of U.S. marketing authorization aligns with Novavax’s strategy to focus on R&D and partnership deals rather than direct commercialization. The company has reported declining revenue—$682 million in 2024 versus $984 million in 2023—and has implemented cost‑cutting measures, including the sale of its Czech Republic manufacturing facility to Novo Nordisk for $200 million, expected to save approximately $80 million annually.
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