Catalyst overview
Research summary
This catalyst tracks a PDUFA approval decision for Rusfertide (PTG-300) in Polycythemia vera. The expected timing is based on the latest available company guidance and may change.
REVIVE & VERIFY study. 3/3/25- Topline data reported, study met the primary endpoint. 6/1/25- Plenary Presentation at ASCO'25. 8/6/25- NDA filing in Q4 2025. 8/25/25- Breakthrough Therapy designation. 11/3/25- Oral & poster presentations at ASH'25 on December 6-9, 2025. 11/06/25:- Rusfertide VERIFY Ph3 week 52 data will be highlighted in four ASH 2025 presentations in December. Partner Takeda continues to expect U.S. NDA filing for PV in Q4 2025. 12/05/25:- VERIFY Week 52 and THRIVE data at ASH 2025 showed durable response and major phlebotomy reduction. 01/01/26:- NDA submitted to U.S. FDA for PV based on VERIFY, REVIVE, and ongoing THRIVE extension data. 02/25/26:- U.S. rusfertide NDA under review; potential approval and launch in 2026; opt-out from Takeda P&L expected Q2 2026. 03/01/26:- FDA accepted rusfertide NDA; Priority Review granted. PDUFA goal date set for Q3 2026. 03/18/26:- Pending FDA decision for rusfertide reiterated for 2026; no new date. 05/05/26:- PDUFA target now August 2026. Rusfertide opt-out exercised; $200M fee and enhanced royalties. 06/01/26:- Four EHA 2026 posters on rusfertide PV due June 12, 2026. PDUFA remains August 2026. 08/05/26:- PDUFA remains August 2026 under FDA Priority Review.
Verification
Confirm timing and program details against the company announcement or filing.