WINSTON-SALEM, N.C., July 15, 2025 - ProKidney Corp. (Nasdaq: PROK), a leading late clinical-stage cellular therapeutics company, has announced a significant regulatory milestone with the U.S. Food and Drug Administration (FDA). The FDA has confirmed alignment on the accelerated approval pathway for ProKidney's rilparencel, an autologous cellular therapy aimed at preserving kidney function in patients with advanced chronic kidney disease (CKD) and type 2 diabetes. The ongoing Phase 3 PROACT 1 study, which has enrolled nearly half of the required patients, will serve as the basis for the accelerated approval analysis using the slope of estimated glomerular filtration rate (eGFR) as a surrogate endpoint. Topline data to support the application for accelerated approval is anticipated in Q2 2027. This alignment marks a critical step forward for ProKidney in addressing the needs of patients with high unmet clinical and societal demands.
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