ProKidney finishes enrollment for accelerated approval analysis in Phase 3 kidney disease trial
The company says it is now positioned for topline eGFR slope results in Q2 2027, with cash reported at $181.6 million as of June 30, 2026.
ProKidney Corp. (Nasdaq: PROK) reported on August 10, 2026 that it has completed enrollment of patients contributing to the Phase 3 PROACT 1 accelerated approval efficacy analysis, and said this positions the company for pivotal eGFR slope topline results expected in the second quarter of 2027.1
The company said it remains on track for completion of full enrollment for PROACT 1 in the second half of 2026.1 The accelerated approval analysis is expected to include approximately 320 patients and evaluate annualized eGFR slope as the surrogate endpoint1, while the confirmatory portion of the study is targeting full enrollment of approximately 470 patients in the second half of 2026 for the confirmatory composite time-to-event analysis, with topline results anticipated in the second half of 2029.1
The Phase 3 study, known as REGEN-006 (PROACT 1), is testing rilparencel in patients with advanced chronic kidney disease and type 2 diabetes. According to the release, the trial protocol was revised during the first half of 2024 to narrow enrollment to a subgroup of Stage 4 CKD patients (eGFR of 20 to 30 mL/min/1.73m2) and late Stage 3b CKD patients (eGFR of 30 to 35 mL/min/1.73m2) who also have albuminuria within specified ranges.1
On the leadership side, ProKidney named Kenneth Locke as Chief Technical Officer in June 2026. The company said Locke brings more than 25 years of experience across R&D, Chemistry, Manufacturing, and Controls (CMC) and Supply Chain.1 Most recently he was Senior Vice President of Technical Operations at Carisma Therapeutics, where his responsibilities included CMC, Quality, and Regulatory oversight, and he helped shape technical strategy for the company's first-in-human CAR Myeloid programs.1
On finances, the company held $181.6 million in cash, cash equivalents and marketable securities as of June 30, 2026, down from $224.9 million at March 31, 2026.1 ProKidney said this level of cash is expected to support operating plans into mid-2027.1
Written by readthrough’s AI from the linked primary sources and fact-checked against them automatically before publishing. Not investment advice.