Takeda and Protagonist Therapeutics said the U.S. Food and Drug Administration has accepted a New Drug Application for rusfertide, an investigational hepcidin mimetic peptide for treating adults with polycythemia vera, and granted it Priority Review. The FDA set a PDUFA target action date in the third quarter of the calendar year, and rusfertide has also received Breakthrough Therapy, Orphan Drug and Fast Track designations.

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