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rusfertide

Protagonist Therapeutics · $PTGX

Standard Review Phase 3 Fast Track Breakthrough Therapy

PDUFA Date

July 20, 2026

Time Remaining

118 days

Review Type

Standard (10 mo)

Indication

Polycythemia vera (PV) — phlebotomy-dependent

Key Notes

REVIVE Phase 3 trial topline data expected H2 2026. Rusfertide is a hepcidin mimetic for polycythemia vera. Company guided H2 2026. NDA submission planned following positive data.

⚠️ Not Investment Advice: This information is provided for educational purposes only. PDUFA dates are FDA target action dates, not guaranteed approval dates. The FDA may extend the review period, issue Complete Response Letters, or take unexpected actions. Probability of approval scores are based on historical base rates and do not account for drug-specific factors. Always consult a financial advisor before making investment decisions.

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