ProKidney Announces Alignment with the FDA on the Accelerated Approval Pathway for Rilparencel

FDA confirmed that eGFR slope is an acceptable surrogate endpoint for accelerated approval of rilparencel in patients with CKD and type 2 diabetesFDA also confirmed that the ongoing Phase 3 PROACT 1 study can be used for both accelerated approval and for full approvalNearly half of the patients required for the accelerated approval analysis using eGFR slope have been enrolledTopline data to support an application for accelerated approval is anticipated in Q2 2027 WINSTON-SALEM, N.C., July 15, 2025 (GLOBE NE ...