Shares of Novavax, Inc. NVAX gained 18.7% yesterday after the company announced positive top-line data from a pivotal phase III study on its nanoparticle seasonal influenza vaccine candidate, NanoFlu, for adult patients aged 65 years and above.
In fact, the stock has rallied 20.3% in the past year against the industry’s decline of 19.9%.
With help of the FDA’s criteria for accelerated approval of seasonal influenza vaccines, the phase III study on NanoFlu evaluated the safety and immunogenicity of the candidate using Novavax's proprietary Matrix-M adjuvant in senior patients aged 65 years and older compared to the quadrivalent formulation of Sanofi’s SNY influenza vaccine, Fluzone.
The primary objectives of the study were 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 show NanoFLu’s safety profile.
The study met all the primary goals as well as achieved statistical significance in key secondary endpoints. Novavax plans to submit a biologics license application (BLA) for NanoFLu using the FDA’s accelerated approval pathway. The company expects to make NanoFLu available in the market as early as possible.
Notably, in January 2020, the FDA granted a Fast Track designation to NanoFlu for adult patients aged 65 years and above. In June 2019, the regulatory agency had acknowledged Novavax’s plans to use the accelerated approval pathway for NanoFlu.
We remind investors that recently, Novavax was in the spotlight following its launched efforts to develop a novel vaccine to protect from the coronavirus disease COVID-19.
In March, the Coalition for Epidemic Preparedness (CEPI) awarded an initial funding of $4 million to support Novavax’s efforts to develop a COVID-19 vaccine. Both CEPI and the company are in talks regarding additional funding from CEPI to cover the costs through the phase I.
CEPI also provided funding to other small-scale biotechs like Moderna, Inc. MRNA, CureVac and Inovio Pharmaceuticals, Inc. INO to push potential vaccine candidates for early-stage clinical studies within a few months.
The World Health Organization declared the COVID-19 outbreak a pandemic, given the alarming levels of its spread and severity. With the global coronavirus outbreak relentlessly posing a threat to human health, a speedy development of vaccines is the need of the hour.
We remain optimistic about the developments in pharma sector as several companies along with global authorities are laboring hard on rolling out a treatment as early as possible to neutralize this deadly virus.
Novavax currently carries Zacks Rank #3 (Hold). You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.
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