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Protagonist Exercises Rusfertide U.S. Opt-Out Right Under Takeda Collaboration

PTGX
  • Protagonist Therapeutics exercised its right to opt out of a 50:50 U.S. profit and loss sharing arrangement with Takeda for rusfertide.
  • The opt-out election makes Protagonist eligible for $200 million payable immediately upon exercise.
  • An additional $200 million becomes payable upon FDA approval of rusfertide for polycythemia vera (PV).
  • U.S. approval triggers a separate $75 million milestone payment.
  • Total potential cash tied to the opt-out election and U.S. approval reaches $475 million.
  • Takeda now holds exclusive development and commercialization rights to rusfertide in the United States.
  • Protagonist becomes eligible for up to $975 million in milestone payments & tiered royalties on worldwide net sales.
  • Worldwide royalty rates range from 14% to 29%, with a weighted-average rate of approximately 21% at $1.5 billion in annual sales.
  • The top royalty tier of 29% applies to annual net sales exceeding $1.5 billion.
  • Rusfertide is under FDA Priority Review with a PDUFA target action date in the third quarter of 2026.
  • The opt-out structure provides meaningful near-term non-dilutive cash & enhances long-term economic participation for Protagonist.
  • Protagonist previously received a $300 million upfront payment under the January 2024 collaboration agreement with Takeda.
  • Rusfertide is a first-in-class hepcidin mimetic peptide demonstrating control of hematocrit in Phase 2 & 3 studies for PV.
  • The program holds Breakthrough Therapy Designation from the FDA.
  • Protagonist's other candidate, ICOTYDE, was launched in the U.S. in March 2026 & is approved for plaque psoriasis.