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
- Are Investors Undervaluing Takeda Pharmaceutical Co. (TAK) Right Now? [Yahoo! Finance]Yahoo! Finance
- AI in Pharmacovigilance Course: Comprehensive Introduction to the Transformative Impact of Artificial Intelligence on Drug Safety and Monitoring (ONLINE EVENT: May 18, 2026) [Yahoo! Finance]Yahoo! Finance
- Takeda Pharmaceutical (TAK) was upgraded by Sanford C. Bernstein from "market perform" to "outperform".MarketBeat
- Takeda (TAK) Receives FDA Priority Review for Rusfertide in PV Treatment [Yahoo! Finance]Yahoo! Finance
- Major biopharmaceutical company to lay off nearly 250 workers in MA [Yahoo! Finance]Yahoo! Finance
TAK
Sec Filings
- 4/6/26 - Form 3
- 4/6/26 - Form 3
- 4/6/26 - Form 3
- TAK's page on the SEC website