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GAITHERSBURG, Md. - Novavax, Inc. (NASDAQ:NVAX), currently trading at $6.73 and showing strong profitability with a gross margin of 58%, has received approval from the U.S. Food and Drug Administration (FDA) for its Biologics License Application (BLA) for Nuvaxovid™, a COVID-19 vaccine. According to InvestingPro analysis, the company appears slightly undervalued based on its Fair Value metrics. This authorization allows the use of the vaccine in adults aged 65 and older, as well as individuals aged 12 through 64 with certain underlying health conditions that increase their risk for severe outcomes from COVID-19.
The FDA’s approval of Nuvaxovid™, which is not based on mRNA technology, has triggered a milestone payment of $175 million to Novavax from its collaborator Sanofi. This partnership, established in May 2024, positions Sanofi to lead commercialization efforts, while Novavax stands to gain from ongoing tiered royalties on future vaccine sales. The company’s financial health appears strong, with InvestingPro data showing revenue of $1.25 billion in the last twelve months and a healthy current ratio of 2.06, indicating solid liquidity.
The decision by the FDA was influenced by Phase 3 clinical trial results demonstrating the vaccine’s safety and efficacy in preventing COVID-19. Additionally, the FDA has mandated a Phase 4 trial to further assess the vaccine’s efficacy and safety in a subset of the population aged 50 through 64 without high-risk conditions.
Novavax anticipates the commercial release of the 2025-2026 COVID-19 vaccine formula in the U.S. this fall, following the upcoming FDA Vaccines and Related Biological Products Advisory Committee meeting scheduled for May 22, 2025, and pending strain recommendation.
Nuvaxovid™, which targets the JN.1 variant of the virus, has been available in the U.S. under Emergency Use Authorization since July 2022. It has also received full market approvals in several other regions, including the European Union, United Kingdom, Japan, Canada, Australia, Taiwan, and Singapore.
This vaccine utilizes Novavax’s recombinant nanoparticle technology to produce a non-infectious spike protein that triggers an immune response, aided by the company’s proprietary Matrix-M® adjuvant. Nuvaxovid™ is stored at standard refrigeration temperatures, which simplifies its distribution.
Novavax’s growth strategy includes leveraging its proven technology platform through partnerships and expanding its vaccine portfolio. The recent FDA approval is a testament to the company’s commitment to providing vaccine options for populations most at risk. With a revenue growth of 26% in the last twelve months and analysts expecting continued profitability, the company shows promising momentum. For deeper insights into Novavax’s financial health and growth prospects, investors can access comprehensive analysis and additional ProTips through InvestingPro’s detailed research reports, available for over 1,400 US stocks.
The information in this article is based on a press release statement from Novavax, Inc.
In other recent news, Novavax Inc. reported its financial results for the first quarter of 2025, showcasing a substantial revenue increase to $667 million, far surpassing the anticipated $251.8 million. The company achieved an earnings per share (EPS) of $2.93, significantly exceeding the forecasted loss of $0.43. Novavax’s strong performance was underpinned by product sales of $622 million, which included $63 million from the termination of agreements in Canada and New Zealand. Additionally, the company reduced its current liabilities by over 60% since the end of 2024, ending the quarter with nearly $800 million in cash and receivables. Novavax has raised its 2025 revenue guidance to a range of $975-$1,025 million, with expected milestone payments from partnerships with Sanofi and Takeda. Analysts have noted the company’s strategic focus on reducing liabilities and operational costs, contributing to its robust financial results. The company continues to emphasize its protein-based technology as a key differentiator in the vaccine industry.
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