Rusfertide (PTG-300) FDA Decision Date: 2026-08-31

August 2026

FDA decision expected

Protagonist disclosed an August 2026 PDUFA goal month. The structured Event Date uses August 31 as the month-end representation of this month-level disclosure.

SEC — Protagonist disclosed the August 2026 PDUFA goal month↗

May 5, 2026

PDUFA timing narrowed to August 2026

Protagonist reported that FDA had set the rusfertide PDUFA goal date in August 2026.

SEC — Protagonist first-quarter 2026 update↗

March 2, 2026

FDA accepted the NDA with Priority Review

FDA accepted the rusfertide NDA and granted Priority Review, initially disclosing a target action date in the third quarter of 2026.

Takeda — Rusfertide NDA acceptance and Priority Review↗

January 5, 2026

Rusfertide NDA submitted

Takeda and Protagonist submitted the NDA based primarily on the Phase 3 VERIFY study and supporting Phase 2 REVIVE and THRIVE extension data.

Takeda — Rusfertide NDA submission↗

December 6, 2025

VERIFY Week 52 results presented at ASH

The Phase 3 analysis showed sustained hematocrit control and durable reduction in phlebotomy eligibility through Week 52, with no new safety signals.

Takeda — VERIFY Week 52 and long-term rusfertide data↗

March 3, 2025

VERIFY met its primary and key secondary endpoints

Rusfertide plus standard of care produced a significantly higher clinical response rate than placebo plus standard of care and met all four key secondary endpoints.

Takeda — Positive Phase 3 VERIFY topline results↗

April 1, 2022

Phase 3 VERIFY study started

The randomized pivotal study began evaluating rusfertide plus standard therapy versus placebo plus standard therapy in patients with polycythemia vera.

ClinicalTrials.gov — VERIFY study record (NCT05210790)↗

Rusfertide (PTG-300)

Polycythemia vera · Adults with polycythemia vera

PTGX · Protagonist Therapeutics Inc

Regulatory designations

Priority Review FDA

Breakthrough Therapy FDA

Fast Track FDA

Orphan Drug FDA

Full timeline