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SEP 2 2026
UPCOMING · 91 DAYS TO PDUFA

Protagonist Therapeutics rusfertide $PTGX

for polycythemia vera

NDA · Priority Review

Accepted MAR 2 2026.

About

Polycythemia vera is a rare blood cancer where the bone marrow overproduces red blood cells, often due to a JAK2 gene mutation, which can lead to dangerous blood thickening. Rusfertide is an injectable peptide that mimics hepcidin, a natural hormone that regulates iron levels and red blood cell production. By controlling iron availability, rusfertide may help reduce excessive red blood cell counts and lower the risk of complications like blood clots.

Pivotal trial

THRIVE Phase 3 active not recruiting NCT06033586

The goal of this clinical trial is to assess long-term safety and efficacy of rusfertide in subjects with polycythemia vera. Subjects who complete dosing with rusfertide until the end-of-treatment visit of a Phase 2 rusfertide study and meet the inclusion/exclusion criteria for this study, are eligible to participate in this open-label study and continue treatment with rusfertide.

Source: ClinicalTrials.gov

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