ProKidney Announces Positive Phase 2 REGEN-007 Results and FDA Alignment for Accelerated Approval Pathway of Rilparencel

Reuters08-13

ProKidney Announces Positive Phase 2 REGEN-007 Results and FDA Alignment for Accelerated Approval Pathway of Rilparencel

ProKidney Corp., a company specializing in cell therapeutics for chronic kidney disease, has announced the positive topline results from its Phase 2 REGEN-007 study. The study demonstrated a 78% improvement in the eGFR slope in Group 1 after treatment with rilparencel. Full results from the REGEN-007 study are set to be submitted as a late-breaking clinical trial at the American Society of Nephrology 2025 Kidney Week. Additionally, the FDA has confirmed the use of the eGFR slope as a surrogate endpoint for accelerated approval of rilparencel in patients with type 2 diabetes and advanced chronic kidney disease. The ongoing Phase 3 PROACT 1 study will serve as both the accelerated approval and confirmatory study, with topline data expected in the second quarter of 2027. ProKidney continues to enroll patients for this study and aims to bring a novel treatment option to address the unmet clinical needs in this patient population.

Disclaimer: This news brief was created by Public Technologies (PUBT) using generative artificial intelligence. While PUBT strives to provide accurate and timely information, this AI-generated content is for informational purposes only and should not be interpreted as financial, investment, or legal advice. Prokidney Corp. published the original content used to generate this news brief via GlobeNewswire (Ref. ID: GNW9511247-en) on August 12, 2025, and is solely responsible for the information contained therein.

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