Novavax Begins Phase III Study On Influenza Vaccine Candidate
Zacks Investment Research | Oct 16, 2019 12:15AM ET
Novavax, Inc. (NASDAQ:NVAX) announced that it has initiated a phase III study on its nanoparticle seasonal influenza vaccine candidate NanoFlu. The pivotal study will evaluate the safety and immunogenicity of NanoFlu using the company’s proprietary Matrix-M adjuvant in adult patients aged 65 years and above compared to the quadrivalent influenza vaccine licensed in the United States.
Top-line data from the study is expected to be announced in the first quarter of 2020. The phase III data is likely to support a biologics license application (BLA) for NanoFLu using the FDA’s accelerated approval pathway.
The primary objective of the study is to demonstrate non-inferior immunogenicity as measured by hemagglutination inhibition (HAI) titers of vaccine homologous influenza strains compared to seasonal marketed influenza vaccine.
In June 2019, the FDA acknowledged Novavax’s plans of using the accelerated approval pathway for NanoFlu.
Shares of Novavax were up almost 3% following this development on Tuesday. However, the stock has plunged 86.9% so far this year, underperforming the Zacks Investment Research
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