Takeda and Protagonist Announce U.S. Food and Drug Administration Accepts New Drug Application and Grants Priority Review for Rusfertide as a Potential First-in-Class Therapy for Polycythe...
Takeda Pharmaceutical Company Limited American Depositary Shares (each representing 1/2 of a share of) (TAK)
Company Research
Source: Business Wire
Rusfertide Demonstrated Significant Improvements in Hematocrit Control, Phlebotomy Reduction and Patient Reported Outcomes for Patients with Polycythemia Vera in a Pivotal StudySubmission Primarily Based on Phase 3 VERIFY Study, in Which Rusfertide Plus Standard of Care More Than Doubled Clinical Response Rates, as Well as Four-Year Efficacy and Safety Data from Phase 2 REVIVE/THRIVE StudiesPrescription Drug User Fee Act (PDUFA) Target Action Date is in the Third Quarter of this Calendar Year OSAKA, Japan & CAMBRIDGE, Mass. & NEWARK, Calif.--(BUSINESS WIRE)--Takeda (TSE:4502/NYSE:TAK) and Protagonist Therapeutics, Inc. (“Protagonist”) (NASDAQ:PTGX) today announced that the U.S. Food and Drug Administration (FDA) accepted the New Drug Application (NDA) and granted Priority Review for rusfertide. Rusfertide is an investigational, first-in-class hepcidin mimetic peptide therapeutic for the treatment of adults with polycythemia vera (PV). The FDA has set a Prescription Drug User Fee Ac
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News
- Takeda Pharmaceutical (TAK) was upgraded by Zacks Research from "strong sell" to "hold".MarketBeat
- Keros Therapeutics Reports Recent Business Highlights and Fourth Quarter and Full Year 2025 Financial Results [Yahoo! Finance]Yahoo! Finance
- Takeda plans to lay off 400 employees in US - report [Seeking Alpha]Seeking Alpha
- Positive Phase 3 Data Demonstrate Potential for ENTYVIO® (vedolizumab) to Address Treatment Gap for Children and Adolescents with Moderate to Severe Ulcerative ColitisBusiness Wire
- Assessing Takeda Pharmaceutical (TSE:4502) Valuation After A Strong Run In Recent Months [Yahoo! Finance]Yahoo! Finance
TAK
Sec Filings
- 3/2/26 - Form 6-K
- 2/10/26 - Form 6-K
- 1/29/26 - Form 6-K
- TAK's page on the SEC website