Rusfertide (PTG-300)
Polycythemia vera · Adults with polycythemia vera
PTGX · Protagonist Therapeutics Inc
监管认定
完整时间线
7 个里程碑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↗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↗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↗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↗相关新闻
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