ProKidney (PROK, Financial) has received confirmation from the U.S. Food and Drug Administration (FDA) regarding the accelerated approval route for its autologous cellular therapy, rilparencel. This therapy, which focuses on preserving kidney function in patients with advanced chronic kidney disease (CKD) and type 2 diabetes, is currently under Phase 3 REGEN-006 trials. The FDA has granted Rilparencel the Regenerative Medicine Advanced Therapy designation.
During a Type B meeting, the FDA verified that the estimated glomerular filtration rate (eGFR) slope from the ongoing Phase 3 PROACT 1 study can act as a surrogate endpoint for rilparencel's Biologics License Application. A minimum effect size of 1.5 mL/min/1.73m2/year improvement is required to demonstrate the therapy's efficacy. ProKidney plans to release the top-level data on this surrogate endpoint by Q2 2027 and has already enrolled about half of the necessary patients for this analysis.
Moreover, the FDA has agreed that the ongoing Phase 3 PROACT 1 study may serve as the confirmatory trial for full approval, focusing on a composite time-to-event endpoint. ProKidney aims to provide an updated timeline for this confirmatory data by the first half of 2026.
