USABiotech & Genomic Medicine▲
ProKidney Targets Mid-2026 Enrollment Completion for Rilparencel Trial with Accelerated Approval Path
ProKidney remains on track to complete enrollment for the pivotal portion of its PROACT 1 late-stage trial of rilparencel in mid-2026, with key kidney-function results expected in the second quarter of 2027. The FDA has agreed that the company can use eGFR slope as the primary basis for seeking accelerated approval for the experimental cell therapy, which targets advanced chronic kidney disease in patients with type 2 diabetes. ProKidney highlighted earlier Phase 2 data from the REGEN-007 study showing a 4.6 mL/min/1.73m² improvement in annual kidney-function decline after treatment. The company ended the first quarter with $224.9 million in cash, cash equivalents, and marketable securities, which it expects to fund operations into mid-2027.