ProKidney gains FDA alignment on accelerated approval pathway for rilparencel; topline data Q2 2027

PROKIDNEY CORP.

• FDA confirmed eGFR slope as surrogate endpoint for accelerated approval of rilparencel in CKD with type 2 diabetes.
• Effect size of at least 1.5 mL/min/1.73m2/year required versus sham; nearly half of required patients enrolled.
• Phase 3 PROACT 1 can serve as both the accelerated and confirmatory study; confirmatory readout timing in 1H 2026.
• Topline data for accelerated approval BLA submission anticipated in Q2 2027.
• Rilparencel holds RMAT designation; CEO called it a critical regulatory milestone.