ProKidney Corp. has announced updated results from the Phase 2 REGEN-007 trial and provided an update on the ongoing Phase 3 PROACT 1 registrational program for rilparencel, its investigational autologous cell therapy for patients with advanced chronic kidney disease (CKD) and type 2 diabetes. Full results from the Phase 2 trial were presented at the American Society of Nephrology Kidney Week 2025. In the study, bilateral kidney injection with rilparencel demonstrated a statistically significant and clinically meaningful slowing of CKD progression, with a 4.6 mL/min/1.73m² (78%) improvement in the annual decline of estimated glomerular filtration rate (eGFR) slope in one patient group. No rilparencel-related serious adverse events were observed. The Phase 3 PROACT 1 trial is ongoing, with more than half of the approximately 360 patients required for the accelerated approval analysis already enrolled as of August 2025. The U.S. Food and Drug Administration (FDA) has confirmed that eGFR slope is an acceptable surrogate endpoint for this study, which may support both accelerated and confirmatory approval of rilparencel. Topline data readout to support an application for accelerated approval is anticipated in the second quarter of 2027.