Rusfertide was approved by the FDA on August 28, 2026 for polycythemia vera, the 36th novel drug approval of 2026 on the FDA's Novel Drug Approvals list.
Verified against: FDA action day August 28, 2026 (NDA 220605 ORIG-1) · Announcement August 28, 2026 (sponsor announcement) · Goal date none sourced.
MIMRYLO (rusfertide) approved on August 28, 2026 - as the first hepcidin mimetic for polycythemia vera.
The sponsor guided this decision to Q3 2026; the FDA approved the NDA on August 28, 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.
Primary source: Takeda press release, August 28, 2026 (with FDA press announcement)
FDA record of the action: the FDA approved on August 28, 2026, per NDA 220605 ORIG-1 (FDA letter). The sponsor announced it the same day. Action dates on pdufa.bio come from the FDA's own record, not the press release. Every FDA action we hold, by FDA date: FDA approval letters.
| Fund | Shares | Value at quarter end | Filing |
|---|---|---|---|
| RTW Investments | 5,061,175 | $620.4 million | filed August 14, 2026 |
| Perceptive Advisors | 981,879 | $120.4 million | filed August 14, 2026 |
| OrbiMed Advisors | 42,100 | $5.2 million | filed August 14, 2026 |
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Yes. The FDA approved the application for MIMRYLO (rusfertide) on August 28, 2026, per the FDA's own record. The primary source is linked on this page.
MIMRYLO (rusfertide) is a Protagonist Therapeutics, Inc. (PTGX) program. The FDA decision came on August 28, 2026; the company's own announcement is linked on this page.
Measured over the 120 trading days before the decision (T-120 to T-1), PTGX moved +54.7%. That is the recorded price path into this specific event. Historical measurement, not a prediction, and not investment advice.