Protagonist Therapeutics (PTGX) announced that it has exercised its right to opt out of the 50:50 U.S. profit and loss sharing arrangement under its worldwide license and collaboration agreement with Takeda (TAK) for rusfertide, an investigational first-in-class hepcidin mimetic peptide under U.S. Food and Drug Administration, FDA, Priority Review for the treatment of adults with polycythemia vera. By exercising its opt-out right during the contractual opt-out period, Protagonist becomes eligible to receive up to $400 million in opt-out payments, consisting of $200 million payable upon the opt-out election and a further $200 million payable upon FDA approval of rusfertide for the treatment of adults with PV. In addition, U.S. approval of rusfertide would trigger a $75 million milestone payment, bringing total potential cash payable in connection with the opt-out election and U.S. approval to $475 million.
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