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FDA Recommends Novavax Conduct Added Phase 3 Trial On ResVax

FDA Recommends Novavax Conduct Added Phase 3 Trial On ResVax

Novavax, Inc. (NASDAQ: NVAX), which develops vaccines for infectious diseases, announced updates on its licensure for ResVax. The U.S. Food & Drug Administration has recommend the company conduct an additional Phase 3 trial.

What To Know

ResVax is a late-stage study of Novavax's respiratory syncytial virus vaccine and has failed to hit its main goal.

Novavax has held meetings with several European national regulatory agencies to solicit input on the prepare trial and possible pathways to licensure in Europe. The next step will be to seek formal scientific advice this fall from the European Medicines Authority (EMA), the agency responsible for licensing vaccines for the European Union.

Why It's Important

The Bill & Melinda Gates Foundation provided an $89.1 million grant in support of the Prepare trial and will continues to work with Novavax to introduce ResVax to low and middle income countries.

“We remain encouraged by the ResVax efficacy observed with more severe RSV disease and hospitalizations,” said Novavax CEO Stanley Erck in a press release. “These data, coupled with the favorable safety profile of ResVax, demonstrate a positive public health benefit that warrants continued development to address the global unmet medical need in preventing serious RSV disease.”

Novavax shares traded down 6.7 percent at $5.71 in Monday's pre-market session.

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