Takeda and Protagonist Announce Submission of New Drug Application (NDA) for Rusfertide for Treatment of Polycythemia Vera (PV) [Yahoo! Finance]
Protagonist Therapeutics, Inc. (PTGX)
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Source: Yahoo! Finance
NDA Includes 52-Week Data from Phase 3 VERIFY Study, Which Met the Primary and All Four Key Secondary Endpoints, Showing Rusfertide Provided Durable and Sustained Hematocrit Control and Improved Pre-Specified Patient Reported Outcome Measures Data Underscore the Potential to Shift the Treatment Paradigm for PV Patients to Reduce the Burden of Frequent Phlebotomies and Meaningfully Improve Hematocrit Control OSAKA, Japan & CAMBRIDGE, Mass. & NEWARK, Calif., January 05, 2026 BUSINESS WIRE )--Takeda ( TSE:4502/NYSE:TAK ) and Protagonist Therapeutics (Nasdaq: PTGX) ("Protagonist") announced the submission of a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) seeking approval of rusfertide for the treatment of adults with polycythemia vera (PV). Rusfertide is an investigational first-in-class subcutaneously administered hepcidin mimetic peptide designed to regulate iron homeostasis and red blood cell production to control hematocrit levels in patients with PV.
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- Protagonist Therapeutics (NASDAQ:PTGX) was upgraded by analysts at <a style="font-weight:bold" href="https://weissratings.com/">Weiss Ratings</a> from a "sell (d+)" rating to a "hold (c-)" rating.MarketBeat
- Protagonist Therapeutics (NASDAQ:PTGX) had its "overweight" rating reaffirmed by analysts at Barclays PLC.MarketBeat
PTGX
Earnings
- 11/6/25 - Miss
PTGX
Sec Filings
- 1/13/26 - Form 4
- 1/12/26 - Form 8-K
- 1/6/26 - Form 4
- PTGX's page on the SEC website