MIMRYLO (rusfertide) approved on August 28, 2026 - 33 days before its September 30 PDUFA goal date - as the first hepcidin mimetic for polycythemia vera.
Run-up into the decision (T-120 → T+5)
Daily close, T-120 (3/9/26) through T+2. Run-up high $158.62 on 8/17/26, low $92.36 on 3/13/26 (T-120 to T-1). FDA decision 8/28/26. Historical price action, not a forecast.
Key facts
FDA decision date2026-08-28
OutcomeApproved
Drug / candidateMIMRYLO (rusfertide)
IndicationErythrocytosis in adults with polycythemia vera (PV)
CompanyProtagonist Therapeutics, Inc.
Market-cap tierMid
120-day run-up (T-120→T-1)+54.7%
Cohort decision-day move (history)2.2% median (n=232)
The PDUFA target action date was September 30, 2026; the FDA approved the NDA on August 28, 33 days early, under Priority Review. MIMRYLO is a first-in-class hepcidin mimetic, administered once weekly by subcutaneous injection, that regulates iron distribution to control hematocrit in adults with polycythemia vera. Approval rests on the Phase 3 VERIFY study (NCT05210790, 293 patients): 76.9% of MIMRYLO patients achieved a clinical response during weeks 20-32, with reduced phlebotomy burden and improved fatigue versus placebo on top of standard of care. The most common adverse reactions were injection site reactions (56%) and anemia (16%). Protagonist discovered rusfertide and led development through Phase 3; Takeda holds exclusive global development and commercialization rights. FDA announced the approval as the first drug of its kind for this rare blood disorder.
Run-up figures are the stock's own daily closing path over the 120 trading days before the decision, from our price history. Cohort move is the historical median absolute decision-day move for this market-cap tier. History, not a prediction.
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