Protagonist and Takeda announce positive Phase 3 topline data for rusfertide in polycythemia vera; primary endpoint met

Protagonist Therapeutics, Inc

77% of rusfertide patients achieved clinical response vs 33% placebo (p<0.0001) during weeks 20-32.
Mean phlebotomies per patient: 0.5 rusfertide vs 1.8 placebo (p<0.0001) over 32 weeks (EU primary endpoint).
All four key secondary endpoints met, including hematocrit control and patient-reported outcomes.
Safety profile consistent with prior studies; no new safety signals; serious AEs not drug-related.
NDA filing for rusfertide expected in second half of 2025.

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