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Novavax To Evaluate Flu-COVID-19 Vaccine Combo

Novavax To Evaluate Flu-COVID-19 Vaccine Combo

Novavax, Inc. (NASDAQ: NVAX) shares were advancing strongly Tuesday after the coronavirus vaccine developer announced updates on its influenza and coronavirus vaccine candidates.

What Happened: Gaithersburg, Maryland-based Novavax said it has formed a leadership team to advance its NanoFlu vaccine candidate to global regulatory approval as well as to explore a combined influenza and COVID-19 vaccine that could be used in a post-pandemic setting.

"The new team will establish a separate NanoFlu development unit within Novavax, building on the company's established knowledge base in the discovery and development of innovative vaccines to prevent serious infectious diseases," the company said.

Novavax announced the promotion of Russell Wilson to the newly created role of NanoFlu general manager.

Wilson will be assisted by several Novavax veterans who led the development of the vaccine through completion of its successful pivotal Phase 3 clinical trial and has also recently completed key activities related to the development of NVX-CoV2373, Novavax said.

In late March, Novavax reported positive top-line results for the pivotal late-stage trial for NanoFlu, which is being evaluated in adults 65 and older. 

Related Link: The Week Ahead In Biotech: J&J Earnings Kickstarts Pharma Earnings, More IPOs In The Pipeline

Why It's Important: A dedicated team can help accelerate all activities required to file a biologic license application for NanoFlu and also aid in extensive development and manufacturing work that's underway for the NVX-CoV2373 coronavirus vaccine candidate, according to the company. 

What's Next: Novavax is expected to commence the U.S. leg of the Phase 3 study of NVX-CoV2373 shortly, having already initiated a late-stage study in the U.K.

The company is also due to release interim immunogenicity and safety data from the Phase 2 portion of the Phase 1/2 study in the fourth quarter of 2020.

For NanoFlu, a BLA filing could be the next catalyst ahead.

NVAX Price Action: At last check, Novavax shares were up 8.06% to $119.10. 

Related Link: FDA's COVID-19 Vaccine Guidance Shows 'Substantial' Obligations For Developers: Analyst


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