Novavax (NASDAQ:NVAX) was up 18% premarket on average volume following its announcement that the FDA has granted Fast Track status for its planned marketing application for recombinant quadrivalent flu vaccine NanoFlu.
Topline data from a Phase 3 study should be available by quarter-end.
Fast Track status provides for more frequent interaction with the FDA review team and a rolling review of the marketing application.
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