TakedaandProtagonistAnnounceU.S.FoodandDrugAdministrationAcceptsNewDrugApplicationandGrantsPriorityReviewforRusfertideasaPotentialFirst-in-ClassTherapyforPolycythemiaVera
===2026/3/2 17:48:45===
tone, thereby bringing a successful closure to our more than decade-long journey from concept-to-commercialization.”
In January 2024, Protagonist and Takeda entered into a worldwide license and collaboration agreement for rusfertide. Protagonist discovered rusfertide and led its development through Phase 3 studies, with Takeda responsible for implementing the regulatory strategy for the U.S. NDA filing and for leading any future global regulatory filings. Protagonist holds an option to co-commercialize in the U.S. through a 50/50 profit and loss share structure or to opt-out of this structure, providing Takeda with a worldwide license pursuant to the license and collaboration agreement.
About Rusfertide
Rusfertide is a first-in-class investigational subcutaneous treatment that mimics the action of hepcidin, a natural hormone that regulates iron homeostasis and red blood cell production. By targeting the underlying mechanism of iron dysregulation in polycy
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