PTGX PDUFA Date: Rusfertide Updated August 19, 2026 ยท next FDA decision on the calendar FDA decision (PDUFA) target Sep 30, 2026 · Protagonist Therapeutics Inc. · Polycythemia vera
Key facts FDA PDUFA target date 2026-09-30
Drug / candidate Rusfertide
Indication Polycythemia vera
Company Protagonist Therapeutics Inc.
Market-cap tier Large
New to FDA decisions? Read what a PDUFA date is and how often the FDA approves drugs .
See the full 2026 PDUFA calendar → All September 2026 PDUFA dates → FAQ When is the PTGX PDUFA date? The FDA PDUFA target date for PTGX (Protagonist Therapeutics Inc.) is 2026-09-30 for Rusfertide. Dates are company/FDA-sourced and can slip. Verify against primary filings.
What is PTGX's drug Rusfertide? Rusfertide is Protagonist Therapeutics Inc.'s candidate under FDA review for Polycythemia vera.
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