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Novavax Rises on Fast Track Designation to Influenza Vaccine

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Shares of Novavax, Inc. NVAX gained 9.8% yesterday after the FDA granted a Fast Track designation to its nanoparticle seasonal influenza vaccine candidate NanoFlu for adult patients aged 65 years and above.

However, the stock has plunged 89.6% in the past year compared with the industry’s decrease of 2.6%.

The fast track tag from the FDA is designed to provide certain benefits and expedite its review time for new drugs/vaccines that treat serious or life-threatening conditions and demonstrate the potential to address unmet medical needs.

Notably, in October 2019, Novavax initiated the phase III study on NanoFlu, which evaluated the safety and immunogenicity of the candidate using the company’s proprietary Matrix-M adjuvant in senior patients aged 65 years and older compared to the quadrivalent formulation of Sanofi’s (SNY - Free Report) influenza vaccine Fluzone.

The primary objectives of the study are to demonstrate non-inferior immunogenicity of NanoFlu as measured by hemagglutination inhibition (HAI) titers of vaccine homologous influenza strains compared to Fluzone High-Dose and also to show NanoFLu’s safety profile.

Top-line data from this study is expected by the end of first-quarter 2020. The company is optimistic that this data will to support a biologics license application (BLA) for NanoFLu using the FDA’s accelerated approval pathway.

In June 2019, the regulatory agency had acknowledged Novavax’s plans of using the accelerated approval pathway for NanoFlu.

We remind investors that last January, Novavax had announced 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 Fluzone High-Dose.

Meanwhile, Novavax is in discussion with regulatory bodies and potential partners to bring its respiratory syncytial virus (RSV) vaccine candidate ResVax to the market globally. The candidate is being developed in a phase III study to protect vulnerable infants from RSV disease.

Zacks Rank & Stocks to Consider

Novavax currently carries a Zacks Rank #4 (Sell).

Better-ranked stocks in the biotech sector include Exact Sciences Corporation EXAS and Denali Therapeutics Inc. DNLI, both sporting a Zacks Rank #1 (Strong Buy). You can see the complete list of today’s Zacks #1 Rank stocks here.

Exact Sciences’ loss per share estimates have narrowed 6.7% for 2020 over the past 60 days. The stock has rallied 18.6% in the past year.

Denali’s loss per share estimates have narrowed 0.4% for 2020 over the past 60 days.

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