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GAITHERSBURG, Md. - Novavax, Inc. (NASDAQ:NVAX), a biotech company whose stock has surged 12% in the past week according to InvestingPro data, announced Thursday that its H5N1 avian influenza vaccine candidate demonstrated robust immune responses in preclinical studies, according to peer-reviewed data published in Nature Communications.
The vaccine, which uses Novavax’s recombinant protein-based nanoparticle technology and Matrix-M adjuvant, showed effectiveness with either single or two-dose administration via intranasal or intramuscular routes in nonhuman primates.
Results indicated that a single dose administered intranasally produced neutralizing antibody responses at a titer of 1:54, while intramuscular administration achieved a titer of 1:1,160. Both exceeded the 1:40 titer generally considered protective. Two-dose regimens showed even higher immunity levels.
The data also suggested the vaccine candidate elicited broad antibody responses that could potentially protect against forward-drift variants of currently circulating H5N1 strains.
"These preclinical results underscore the promise and potential of our pandemic influenza program as well as the strength of our technology platform," said Ruxandra Draghia-Akli, Executive Vice President and Head of Research and Development at Novavax. The company’s financial health appears robust, with InvestingPro data showing a strong revenue growth of 26% and more cash than debt on its balance sheet.
H5N1, a highly pathogenic avian influenza virus, has caused 70 confirmed human cases in the U.S. and one death, according to the company’s statement. No cases of human-to-human transmission have been proven in the U.S. as of July 2025.
The company stated it intends to pursue funding, partnership and licensing opportunities for its H5N1 vaccine candidate as part of its corporate growth strategy.
The information in this article is based on a press release from Novavax.
In other recent news, Novavax announced promising preclinical results for its H5N1 avian influenza vaccine candidate, which demonstrated strong immune responses in nonhuman primates. These results were published in Nature Communications and highlighted the vaccine’s effectiveness against current H5N1 variants. Additionally, Novavax reported positive outcomes for its COVID-19-Influenza Combination (CIC) and standalone trivalent influenza vaccine candidates in a Phase 3 trial, with both showing robust immune responses comparable to licensed vaccines. In corporate governance matters, Novavax shareholders elected three Class III directors and approved executive pay at the company’s annual meeting. The elected directors, Rachel K. King, John W. Shiver, and Charles W. Newton, will serve three-year terms. Furthermore, Citi initiated coverage of Novavax with a sell rating, expressing concerns about the company’s strategic shift from focusing on its COVID-19 vaccine. Lastly, the FDA announced plans to require new clinical trials for COVID-19 booster shots for healthy Americans under 65, potentially affecting the availability of these boosters.
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