Novavax lifts 2025 revenue outlook after FDA milestone payment

Published 06/08/2025, 13:36
© Reuters

Investing.com -- Novavax on Wednesday raised its full-year revenue forecast as it received a $175 million milestone payment from Sanofi (NASDAQ:SNY) following U.S. approval of its COVID-19 vaccine, Nuvaxovid.

The company’s shares rose 2% in early trading.

The company reported second-quarter revenue of $239 million, driven largely by the FDA’s approval of the Biologics License Application (BLA) for Nuvaxovid.

The company now expects full-year revenue between $1 billion and $1.05 billion, up from its previous range of $975 million to $1.025 billion.

The biotech reported total revenue of $239 million during the reported quarter, lower than last year. 

The vaccine, the only non-mRNA COVID-19 option available in the U.S., was approved for adults aged 65 and older and for individuals aged 12–64 at high risk of severe outcomes.

Novavax (NASDAQ:NVAX) completed the handover of U.S. commercial leadership for Nuvaxovid to Sanofi ahead of the 2025–2026 vaccination season.

Marketing authorizations in the U.S. and EU are expected to transfer to Sanofi in the fourth quarter, triggering an additional $50 million in milestone payments.

Meanwhile, early data from a Phase 3 trial showed strong immune responses for Novavax’s COVID-19-influenza combination and stand-alone flu vaccine candidates.

Both candidates demonstrated T-cell responses numerically higher than those from Sanofi’s Fluzone HD, suggesting potential for longer protection.

Novavax said it is in talks to partner those late-stage programs and does not plan further material investment.


 

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