On June 8, 2022, BioCryst Pharmaceuticals announced that they have received Fast Track Designation from the U.S. Food & Drug Administration (FDA) for their investigational drug to treat FOP, BCX9250. Fast Track Designation allows for companies to have more frequent engagement with the FDA and allows a company to be eligible for accelerated approval/priority review (a 6-month review timeline). Only drugs being developed for serious, unmet medical conditions can receive Fast Track Designation. BioCryst has previously completed a phase 1 trial of BCX9250 in healthy humans. Congratulations to BioCryst Pharmaceuticals for achieving this important milestone!
Read the full press release
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