Takeda And Protagonist Therapeutics Submitted New Drug Application To FDA Seeking Approval Of Rusfertide For Polycythemia Vera
Benzinga Newsdesk 10 months ago
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Under the terms of its January 2024 worldwide license and collaboration agreement with Takeda, the submission of the NDA triggers the start of a 120-day period, after which Protagonist can decide to exercise its opt-out
Under the terms of its January 2024 worldwide license and collaboration agreement with Takeda, the submission of the NDA triggers the start of a 120-day period, after which Protagonist can decide to exercise its opt-out right during a subsequent 90-day period. If Protagonist chooses to exercise this opt-out right, it would be eligible to receive up to $400 million in opt-out payments as well as enhanced milestone payments and 14-29% tiered royalty rates on worldwide net sales of rusfertide.