Takeda, Protagonist share positive rusfertide phase 3 VERIFY data

Takeda and Protagonist Therapeutics have revealed new 52-week results from the Phase 3 VERIFY study, showing that rusfertide delivers durable response and hematocrit control in patients with polycythemia vera (PV). The findings, presented at the 67th American Society of Hematology Annual Meeting, reinforce rusfertide's efficacy and safety, with 61.9% of continuously treated patients maintaining absence of phlebotomy eligibility.

The 52-week data builds on previously reported 32-week primary analysis, which met its primary efficacy endpoint and all four key secondary endpoints. Patients who crossed over from placebo to rusfertide at 32 weeks achieved a similar response rate, with 77.9% showing absence of phlebotomy eligibility between weeks 40-52. Furthermore, four-year results from the combined REVIVE and THRIVE studies demonstrated a 13-fold reduction in the annual rate of phlebotomies from baseline.

Rusfertide has received Breakthrough Therapy, Orphan Drug, and Fast Track Designations from the U.S. FDA, underscoring its potential to address a significant unmet need in PV management. The impact of these study results on Takeda's financial performance for the fiscal year ending March 31, 2026, is considered immaterial.