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SEP 2 2026
UPCOMING · 33 DAYS TO PDUFA

Protagonist Therapeutics rusfertide $PTGX

for polycythemia vera

NDA · Priority Review

Accepted MAR 2 2026.

About

Polycythemia vera is a blood cancer where the bone marrow overproduces red blood cells, thickening the blood and increasing the risk of clots and strokes. Rusfertide is an injectable peptide that mimics the liver hormone hepcidin, which regulates iron availability for red blood cell production. By limiting iron, the drug may reduce excessive red cell counts and help control the symptoms and complications of the disease.

Pivotal trial

VERIFY Phase 3 active not recruiting NCT05210790

The study is designed to evaluate the safety and efficacy of rusfertide in subjects with polycythemia vera (PV) in maintaining hematocrit control and in improving symptoms of PV.

Source: ClinicalTrials.gov

Also in development