Novavax Shares Rally On Flu Vaccine Study Results: What You Need To Know

Novavax, Inc. NVAX, which was in the news recently on account of its COVID-19 vaccine development program, is in the spotlight yet again Tuesday. 

Flu Vaccine Candidate Aces Study

The small-cap late-stage biotech announced positive top-line results Tuesday for its pivotal late-stage study of its influenza vaccine candidate NanoFlu, which is being evaluated in adults 65 and older.

NanoFlu is Novavax's recombinant quadrivalent seasonal flu vaccine with the company's proprietary Matrix-M adjuvant.

The late-stage study evaluated the immunogenicity and safety of NanoFlu Quadrivalent compared to Fluzone Quadrivalent, a U.S.-licensed quadrivalent influenza vaccine marketed by Sanofi SA SNY.

The primary objectives of the study were to demonstrate non-inferior immunogenicity of NanoFlu relative to Fluzone Quadrivalent using two parameters: the day 28 ratio of geometric mean titers and the difference in semiconversion rates. The study also assessed the overall safety of NanoFlu.

Novavax said NanoFlu achieved the primary endpoints using the two parameters for all four strains included in the vaccine, and was also found to be well-tolerated, with a safety profile comparable to Fluzone Quadrivalent and a modest increase in local adverse events.

The vaccine candidate achieved statistical significance in key secondary endpoints, according to Novavax. 

Novavax Plans To Market Vaccine Quickly

Novavax said it expects to submit a BLA under FDA's accelerated approval pathway.

"These strong Phase 3 results align with and validate our previous clinical trials, in which NanoFlu showed higher HAI antibody responses than the leading flu vaccine for older adults," Novavax CEO Stanley Erick said in a statement. 

"We expect that both Fast Track designation and the accelerated approval pathway from the FDA will help Novavax bring NanoFlu to market as quickly as possible to address the serious public health threat of influenza." 

The stock was surging 39.03% to $14.96 in premarket trading Tuesday.

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