Novavax, Inc. (NVAX) Wins FDA Approval for Nuvaxovid BLA

We recently compiled a list of the 11 Cheap Biotech Stocks to Buy According to Hedge Funds. Novavax, Inc. is one of them.

Novavax, Inc. (NASDAQ:NVAX) is a biotechnology company specializing in vaccines for serious infectious diseases, with its leading product, Nuvaxovid™, a recombinant protein-based COVID-19 vaccine approved for adults 65+ and high-risk individuals aged 12–64 in the U.S. The vaccine combines recombinant protein technology with nanoparticle and Matrix-M adjuvant to enhance immune responses.

In August 2025, Novavax, Inc. (NASDAQ:NVAX) received FDA approval for Nuvaxovid’s Biologics License Application, triggering a $175 million milestone payment from partner Sanofi. The company transferred U.S. commercial leadership of Nuvaxovid to Sanofi for the 2025–2026 vaccination season, with further marketing authorization transfers in the U.S. and EU expected later in 2025, generating additional milestone payments.

The business is expanding its pipeline beyond COVID-19, including COVID-19–influenza combination vaccines and a standalone influenza vaccine in Phase 3, showing strong immune responses and T-cell activity. Its H5N1 avian flu candidate also produced promising preclinical results, boosting investor confidence.

Financially, Novavax, Inc. (NASDAQ:NVAX) reported an unexpected net income of $107 million in Q2 2025, aided by milestone payments, cost reductions, and organizational efficiencies. The corporation also refinanced convertible debt in August 2025, improving terms and extending maturities to support pipeline advancement and partnership strategies.

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