Protagonist Exercises U.S. Rusfertide Opt-Out for $475M Upfront and $975M Milestones
Protagonist exercised its U.S. opt-out right under the Takeda collaboration for rusfertide, securing $200 million upon election and $200 million upon FDA approval, plus a $75 million approval milestone for a total of $475 million. The company retains eligibility for up to $975 million in additional milestones and tiered 14%–29% royalties worldwide.
1. Opt-Out Election Terms
During the contractual opt-out period, Protagonist elected to exit the 50:50 U.S. profit-and-loss share with Takeda, triggering a $200 million payment upon election and another $200 million tied to FDA approval. U.S. commercialization rights now rest exclusively with Takeda as a result of this election.
2. FDA Approval Milestone
FDA approval of rusfertide for adult polycythemia vera would unlock a $75 million milestone payment, bringing total cash from the opt-out election and approval to $475 million. The Prescription Drug User Fee Act target action date is set for the third quarter of 2026.
3. Future Milestone and Royalty Structure
Beyond U.S. payments, Protagonist is eligible for up to $975 million in global milestone payments plus tiered royalties ranging from 14% to 29% on net sales. The weighted-average royalty rate of approximately 21% applies at $1.5 billion in annual sales, rising to 29% above that threshold.