FDA Grants Priority Review for Takeda (TAK) and Protagonist's Rusfertide in PV Treatment [Yahoo! Finance]
Takeda Pharmaceutical Company Limited American Depositary Shares (each representing 1/2 of a share of) (TAK)
Company Research
Source: Yahoo! Finance
announced that the US FDA accepted the New Drug Application and granted Priority Review for rusfertide. This investigational, first-in-class hepcidin mimetic is intended to treat adults with polycythemia vera/PV, a rare blood cancer characterized by the dangerous overproduction of red blood cells. Given its potential to address significant unmet needs, the FDA has set a Prescription Drug User Fee Act action date for Q3 2026. The regulatory submission is supported by data from the Phase 3 VERIFY study, along with long-term results from the Phase 2 REVIVE and THRIVE trials. Clinical findings showed that rusfertide, when added to the standard of care, more than doubled response rates compared to standard treatments alone. Key benefits included sustained control of hematocrit levels below 45%, a significant reduction in the need for painful phlebotomy procedures, and improvements in patient-reported symptoms such as fatigue. Under the 2024 collaboration agreement, Takeda is managing t
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News
- ????????????:2026???2036?????????? [CNET News]CNET 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
- 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 Polycythemia VeraBusiness Wire
TAK
Sec Filings
- 3/18/26 - Form 3
- 3/18/26 - Form 3
- 3/18/26 - Form 3
- TAK's page on the SEC website