Novavax, Inc. 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 industry’s decrease of 6.4%.
We remind investors that in January 2019, Novavax released top-line data from a phase II study on NanoFlu. Results from the same showed that NanoFlu improved immune responses in adults aged 65 years or older compared to Sanofi’s SNY leading influenza vaccine Fluzone High-Dose.
Apart from NanoFlu, the company has ResVax — a respiratory syncytial virus (RSV) vaccine candidate — in its portfolio.
Earlier this year, ResVax failed to meet the primary endpoint in a phase III study of prevention from medically significant RSV and lower respiratory tract infection. However, the study did show efficacy against a secondary objective of preventing hospitalization and is the first RSV vaccine to demonstrate phase III efficacy.
Zacks Rank & Stocks to Consider
Novavax currently carries a Zacks Rank #3 (Hold). Better-ranked stocks in the biotech sector include Incyte Corporation INCY and NuCana PLC NCNA, both sporting a Zacks Rank #1 (Strong Buy). You can see the complete list of today’s Zacks #1 Rank stocks here.
Incyte’s earnings estimates have been revised 1.5% upward for 2019 and 1.5% for 2020 over the past 60 days. The stock has rallied 23.5% year to date.
NuCana’s loss per share estimates have been narrowed 17.5% for 2019 and 16.7% for 2020 over the past 60 days.
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