Shares of Novavax (NVAX) - Get Report were soaring 18.8% to $12.78 Tuesday after the biotech company said its NanoFlu treatment for seasonal flu achieved all primary endpoints in a phase 3 trial for adults 65 and older.
“With these data, we now have a clear path forward to licensure with our differentiated recombinant influenza vaccine,” Stanley C. Erck, president and CEO of the Gaithersburg, Md.-based company, said in a statement. “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."
Erck added that "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.”
NanoFlu was well-tolerated and had a safety profile comparable to Fluzone Quadrivalent with a modest increase in local adverse events (AEs), Novavax said.
“In addition to meeting the primary objectives, we are very pleased to report that NanoFlu also met or exceeded its secondary endpoints for all four strains using our proprietary HAI assay based upon wild-type reagents,” said Gregory Glenn, president of research and development of Novavax.
Earlier this month, Novavax announced it had received $4 million of funding from the Coalition for Epidemic Preparedness to develop a coronavirus vaccine.
CEPI is a global partnership between public, private, civil and philanthropic groups launched in 2017 to develop vaccines to stop epidemics. The company has produced and is now analyzing multiple vaccine candidates in animals before embarking on clinical trials. It said clinical testing will likely begin in late spring.