Novavax Inc. (NASDAQ: NVAX) shares jumped on Wednesday after the U.S. Food and Drug Administration (FDA) granted a Fast Track Designation for NanoFlu, its recombinant quadrivalent seasonal influenza vaccine candidate, adjuvanted with Matrix-M, in adults 65 years of age and older.
The company has an ongoing Phase 3 clinical trial that is intended to evaluate the immunogenicity and safety of NanoFlu compared to the quadrivalent formulation of Fluzone.
The trial’s primary objectives are to demonstrate non-inferior immunogenicity as measured by hemagglutination inhibition titers of vaccine homologous influenza strains compared to Fluzone and to describe its safety profile.
Top-line clinical data from the trial is expected by the end of the first quarter of 2020 and could support a U.S. biologics license application and future licensure of NanoFlu using the FDA’s accelerated approval pathway.
Stanley C. Erck, president and CEO of Novavax, commented:
The FDA’s decision to grant Fast Track Designation for NanoFlu reflects the urgent unmet medical need for a more effective vaccine against influenza, particularly in the older adult population which often experiences serious and sometimes life-threatening complications, of the disease. We believe that NanoFlu will offer an innovative improvement compared to traditional egg-based vaccines, which frequently result in mismatch and poor effectiveness. We look forward to working closely with the FDA through the expedited review process, accelerating the access to this vaccine for the most vulnerable populations.
Novavax stock was last seen up about 8%, at $4.32 a share in a 52-week range of $3.54 to $48.80. The consensus price target is $13.75.