Novavax Inc. (NASDAQ: NVAX) shares jumped early on Friday after the company reported that its midstage flu vaccine had some positive results.
Essentially, the firm announced topline results of its Phase 2 clinical trial of NanoFlu, wherein it compared the safety and immune responses of various quadrivalent formulations of NanoFlu, with or without Novavax’s Matrix-M adjuvant, with two U.S.-licensed influenza vaccines in 1,375 healthy adults 65 years of age and older.
Some of the main findings of the study were that NanoFlu was well-tolerated and elicited vigorous immune responses to the four strains included in the vaccine. Separately, NanoFlu demonstrated that it is a differentiated flu vaccine, as evidenced by significantly superior hemagglutination inhibition antibody responses against wild-type A(H3N2) viruses.
Previously the U.S. Food and Drug Administration (FDA) acknowledged that the accelerated approval pathway may be available for NanoFlu, which could allow for licensure of NanoFlu in a shorter timeframe. Novavax plans to meet with the FDA in the first half of 2019 to discuss the Phase 2 clinical trial data, the proposed Phase 3 trial design and the use of accelerated approval for licensure.
Gregory Glenn, M.D., president of research and development at Novavax, said:
The superior immunogenicity against wild-type H3N2 viruses holds promise that NanoFlu will more effectively address the mismatch between circulating viruses and the strains included in most commercial vaccines due to genetic drift and vaccine virus egg adaptation. Older adults experienced the brunt of the serious health consequences of this mismatch, with H3N2 driving the majority of influenza hospitalizations and death during 2017-2018, the worst flu season in four decades. Over the past several years, influenza vaccine effectiveness has been suboptimal in this population, and there is broad agreement that better vaccines are needed. These confirmatory data from the second clinical trial of NanoFlu further justify continued rapid development of an improved vaccine.
Shares of Novavax closed Thursday at $2.04, with a consensus analyst price target of $4.33. The stock has a 52-week trading range of $1.92 to $2.75. Following the announcement, the stock was up about 11% at $2.26 in early trading indications Friday.