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

Core Viewpoint - ProKidney Corp. has received confirmation from the FDA regarding the accelerated approval pathway for its autologous cellular therapy, rilparencel, aimed at treating chronic kidney disease (CKD) in patients with type 2 diabetes, marking a significant regulatory milestone for the company [1][3][6] Group 1: FDA Confirmation and Clinical Trials - The FDA confirmed that the estimated glomerular filtration rate (eGFR) slope can serve as a surrogate endpoint for the accelerated approval of rilparencel, with an effect size of at least 1.5 mL/min/1.73m²/year required to demonstrate efficacy [2][6] - ProKidney anticipates topline data readout supporting the accelerated approval application in Q2 2027, with nearly half of the required patients already enrolled in the ongoing Phase 3 PROACT 1 study [2][6] - The ongoing Phase 3 PROACT 1 study may also serve as a confirmatory study for full approval based on the primary time-to-event composite endpoint specified in the protocol [2][6] Group 2: Chronic Kidney Disease Context - Chronic kidney disease (CKD) affects an estimated 37 million adults in the U.S., with diabetes being the leading cause, significantly increasing the risk of cardiovascular events and mortality [4] - ProKidney is focusing on patients with Stage 3b/4 CKD and diabetes, a population estimated to include 1 to 2 million individuals in the U.S., highlighting the substantial unmet need for effective therapies [4] Group 3: ProKidney's Product and Strategy - Rilparencel is a first-in-class, patented autologous cellular therapy developed to preserve kidney function in diabetic patients at high risk of kidney failure [7] - The Phase 3 REGEN-006 (PROACT 1) trial is a randomized, blinded, sham-controlled study with a planned enrollment of approximately 685 subjects, focusing on patients with advanced CKD and type 2 diabetes [5][6]