Takeda and Protagonist Win FDA Priority Review for First-in-Class Polycythemia Vera Drug

The latest announcement is out from Takeda Pharmaceutical Co ( (JP:4502) ).

Takeda and Protagonist Therapeutics said the U.S. Food and Drug Administration has accepted their New Drug Application and granted Priority Review for rusfertide, an investigational first-in-class hepcidin mimetic for adults with polycythemia vera. The filing is backed by the Phase 3 VERIFY trial, which showed rusfertide plus standard care more than doubled clinical response rates versus standard care alone, along with long-term efficacy and safety data from Phase 2 studies.

The FDA has also granted rusfertide Breakthrough Therapy, Orphan Drug and Fast Track designations and set a Prescription Drug User Fee Act decision date for the third quarter of this year. While Takeda expects the NDA acceptance to have an immaterial impact on current fiscal-year results, a potential approval would strengthen its hematology franchise and offer patients a novel option to better control hematocrit, reduce phlebotomy needs and improve symptoms in a disease with significant unmet medical need.

The most recent analyst rating on (JP:4502) stock is a Buy with a Yen6304.00 price target. To see the full list of analyst forecasts on Takeda Pharmaceutical Co stock, see the JP:4502 Stock Forecast page.

More about Takeda Pharmaceutical Co

Takeda Pharmaceutical, headquartered in Osaka, is a global biopharmaceutical company focused on innovative therapies across oncology, hematology and other specialty areas, while Protagonist Therapeutics is a U.S.-listed biotech specializing in peptide-based drugs. Together they are developing rusfertide, a first-in-class hepcidin mimetic peptide aimed at treating polycythemia vera, a rare hematologic cancer marked by overproduction of red blood cells.

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Technical Sentiment Signal: Buy

Current Market Cap: Yen9223.5B

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