GAITHERSBURG, Md. - Novavax , Inc. (NASDAQ:NVAX), whose stock has surged nearly 89% year-to-date and shows significant momentum with a 7.8% gain in the past week, has initiated a Phase 3 clinical trial to evaluate the immunogenicity and safety of its COVID-19-Influenza Combination (CIC) vaccine and a stand-alone seasonal influenza vaccine in adults aged 65 and older. According to InvestingPro analysis, the company currently appears undervalued based on its Fair Value assessment. The trial also involves comparing these candidates to Novavax's updated 2024-2025 COVID-19 vaccine and a licensed seasonal influenza vaccine.
The company announced today that the first participants have been dosed in this latest stage of research. This move builds on positive Phase 2 data and aims to determine the effectiveness and safety of a combination vaccine against both COVID-19 and influenza, as well as the stand-alone influenza vaccine, each incorporating Novavax's patented Matrix-M adjuvant.
Novavax is also in discussions with the U.S. Food and Drug Administration (FDA) regarding the potential for an accelerated approval pathway for these vaccines. The company is currently recruiting an initial cohort of approximately 2,000 participants for the trial while continuing dialogue with the FDA. Clarity on potential next steps and additional clinical work required for registration is expected by Q2 2025.
The company's financial guidance for the fiscal year 2025, which includes combined Research & Development and Selling, General and Administrative expenses, is set at approximately $500 million. This figure encompasses the planned clinical activities for the CIC and stand-alone influenza vaccines but may be subject to revisions based on future developments.
Novavax's portfolio includes their COVID-19 vaccine and other vaccine candidates, with a focus on protein-based vaccines enhanced by innovative adjuvant technologies. The company's adjuvant is also a component in the R21/Matrix-M malaria vaccine developed by the University of Oxford and Serum Institute of India. With a market capitalization of $1.45 billion and maintaining more cash than debt on its balance sheet, the company continues to invest in its development pipeline despite reporting a negative EBITDA of $243 million in the last twelve months.
This news article is based on a press release statement.
In other recent news, Novavax, a U.S. vaccine manufacturer, has sold its Czech facility to Danish pharmaceutical company Novo Nordisk (NYSE:NVO) for $200 million. This sale is part of Novavax's broader strategy to streamline its operations and focus on vaccine development. The company has also entered a significant licensing agreement with French pharmaceutical giant Sanofi (NASDAQ:SNY), which now owns nearly a 5% stake in Novavax.
Analysts from B.Riley and H.C. Wainwright have updated their outlook on Novavax. B.Riley reduced its price target from $26.00 to $22.00 but maintained a Buy rating, citing a mixed fourth-quarter guidance. H.C. Wainwright, on the other hand, maintained a Buy rating and a $19.00 stock price target, highlighting the company's strategic partnership with Sanofi.
In its third-quarter earnings report, Novavax revealed a decrease in revenues to $85 million, down from $187 million in the same quarter of the previous year. Despite this, the company remains optimistic about future growth, especially with the European Commission's marketing authorization for its updated vaccine. These are the latest developments in Novavax's ongoing efforts to remain competitive in the vaccine market.
This article was generated with the support of AI and reviewed by an editor. For more information see our T&C.