NasdaqGM:PTGXBiotechs
Does Rusfertide’s FDA NDA Submission Redefine The Bull Case For Protagonist Therapeutics (PTGX)?
In early January 2026, Takeda and Protagonist Therapeutics announced that they had submitted a New Drug Application to the U.S. FDA for rusfertide, a first-in-class subcutaneous hepcidin mimetic for adults with polycythemia vera, supported by positive Phase 3 VERIFY and Phase 2 REVIVE trial results and multiple expedited regulatory designations.
This filing is important because rusfertide targets the underlying iron dysregulation mechanism in polycythemia vera and, if approved, could offer a...