Novavax (NVAX) Gains Over 46% In 5 Days, To Report Phase 3 NanoFlu Data In Q1

novavax jan21

Shares of Novavax Inc. (NVAX) have gained more than 46% over the last 5 trading days, thanks to positive development related to its NanoFlu vaccine.

Novavax is a late-stage biotechnology company developing next-generation vaccines for serious infectious diseases.

The Company has two late-stage product candidates NanoFlu, a recombinant hemagglutinin (HA) protein nanoparticle influenza vaccine, and ResVax, an aluminum adjuvanted respiratory syncytial virus (RSV) fusion (F) protein recombinant nanoparticle vaccine.

On January 15, 2020, the FDA granted Fast Track Designation for NanoFlu. The Fast track status will expedite the review of the drug.

A phase III clinical trial evaluating the immunogenicity and safety of NanoFlu against the quadrivalent formulation of Fluzone is underway. The trial's primary objectives are to demonstrate non-inferior immunogenicity as measured by hemagglutination inhibition (HAI) titers of vaccine homologous influenza strains compared to Fluzone, and to describe its safety profile.

The top-line clinical data from the trial is expected by the end of the first quarter of 2020. If all goes well as planned, the Company may seek approval of NanoFlu using the FDA's accelerated approval pathway.

The Company reported results from Prepare, a global phase III clinical trial of ResVax, last March. Although the trial did not meet the primary objective of prevention of medically significant (RSV)-associated lower respiratory tract infection (LRTI), it did show efficacy against secondary objective (RSV LRTI hospitalization).

The Company met with the FDA, European regulatory agencies, and potentially other national regulatory agencies to assess opportunities for submission of marketing applications for ResVax. The FDA and the European Medicines Agency have both recommended that Novavax conduct an additional phase III clinical trial to confirm the efficacy of ResVax.

As of September 30, 2019, the Company had $75.9 million in cash, cash equivalents, marketable securities, and restricted cash.

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