BioCryst Pharmaceuticals (NASDAQ:BCRX) +5% as U.S. FDA approves orphan drug designation for its oral Factor D inhibitor, BCX9930, for the treatment of paroxysmal nocturnal hemoglobinuria. Additionally, FDA has also granted fast track designation for BCX9930 in PNH.
Orphan Drug designation qualifies BCX9930 for various development incentives, including tax credits for certain clinical costs, a waiver of the new drug application fee and a designated period of market exclusivity following approval.
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