ProKidney announces alignment with FDA on rilparencel accelerated approval path

ProKidney (PROK) announced confirmation of alignment with the U.S. Food and Drug Administration on the accelerated approval pathway for rilparencel. Rilparencel is an autologous cellular therapy that received Regenerative Medicine Advanced Therapy designation from the FDA and currently is being evaluated in the ongoing Phase 3 REGEN-006 trial to demonstrate the therapy’s potential to preserve kidney function in patients with advanced CKD and type 2 diabetes. In a recent Type B meeting, the FDA confirmed that the slope of estimated glomerular filtration rate in patients from the ongoing Phase 3 PROACT 1 study can serve as the surrogate endpoint and primary basis for a Biologics License Applicationsubmission of rilparencel under the accelerated approval pathway. The FDA agreed that a rilparencel effect size of at least 1.5 mL/min/1.73m2/year improvement would be an acceptable demonstration of efficacy in the setting of patients receiving appropriate standard of care therapies. ProKidney anticipates topline data readout of eGFR slope as the surrogate endpoint to support an application for accelerated approval in Q2 2027. To date, ProKidney has enrolled nearly half of the patients required for the accelerated approval analysis. The FDA also confirmed that the ongoing Phase 3 PROACT 1 study may serve as the confirmatory study to support full approval of rilparencel based on the primary time-to-event composite endpoint specified in the protocol. Updated guidance on the expected timing of the confirmatory readout will be provided in 1H 2026.