Rusfertide wins Breakthrough Therapy status from FDA

26 August 2025

California, USA-based Protagonist Therapeutics (Nasdaq: PTGX) yesterday revealed that its rusfertide, a potential first-in-class hepcidin-mimetic peptide, has been granted Breakthrough Therapy designation by the US Food and Drug Administration (FDA) for the treatment of erythrocytosis in patients with polycythemia vera (PV). In 2020, rusfertide received Orphan Drug status and Fast Track designation.

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