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Novavax: Influenza Vaccine NanoFlu Meets Primary Goals In Phase 3 Clinical Trial

Novavax Inc. (NVAX), a late-stage biotechnology company developing vaccines for serious infectious diseases, announced Tuesday positive top-line results of its pivotal Phase 3 clinical trial of NanoFlu. In pre-market activity on Nasdaq, Novavax shares were gaining around 37.08 percent at $14.75.

In a statement, the company said that NanoFlu, its recombinant quadrivalent seasonal influenza vaccine candidate with its proprietary Matrix-M adjuvant, achieved all primary endpoints in Phase 3 clinical trial in adults aged 65 and older.

The trial used the Food and Drug Administration's criteria for accelerated approval of seasonal influenza vaccines. It evaluated the immunogenicity and safety of NanoFlu compared to Fluzone Quadrivalent, a U.S.-licensed quadrivalent influenza vaccine.

The trial also achieved statistical significance in key secondary endpoints.

Novavax said it will submit a U.S. BLA under FDA's accelerated approval pathway.

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