other material
confidence high
sentiment neutral
materiality 0.65
ProKidney updates PROACT 1 enrollment target to ~470; confirmatory readout now H2 2029
PROKIDNEY CORP.
- Enrollment target increased to ~470 subjects in Phase 3 PROACT 1 (REGEN-006) study.
- Surrogate endpoint (eGFR slope) topline data readout still anticipated Q2 2027.
- Confirmatory endpoint (composite time-to-event) topline data readout now anticipated H2 2029.
- Statistical powering assumptions unchanged for both surrogate and confirmatory analyses.