Takeda and Protagonist announce US FDA accepts new drug application and grants priority review for rusfertide as a potential first in class therapy for polycythemia vera

Takeda

2 March 2026 - Takeda and Protagonist Therapeutics today announced that the US FDA accepted the new drug application and granted priority review for rusfertide. 

Rusfertide is an investigational, first in class hepcidin mimetic peptide therapeutic for the treatment of adults with polycythemia vera. 

The FDA has set a PDUFA goal date in the third quarter of this calendar year.

Read Takeda press release

Michael Wonder

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Michael Wonder