The company highlighted several key accomplishments in 2025, including significant enrollment momentum in the Phase 3 PROACT 1 study of its lead product candidate, rilparencel. ProKidney is on track to complete patient enrollment for the accelerated approval analysis of rilparencel by mid-2026, with pivotal topline results anticipated in Q2 2027. In a July 2025 Type B meeting, ProKidney aligned with the FDA on the accelerated approval pathway for rilparencel, using eGFR slope as a surrogate endpoint.
Additionally, ProKidney presented positive results from the Phase 2 REGEN-007 study of rilparencel at the ASN Kidney Week 2025, which were subsequently published in the Clinical Journal of the American Society of Nephrology. The company is expanding its in-house manufacturing footprint in Winston-Salem, NC, to support its growing operations.
Looking ahead, ProKidney has outlined several anticipated milestones, including the completion of enrollment for the Phase 3 PROACT 1 study and the presentation of results from ongoing mechanism of action studies at medical conferences throughout FY 2026. The company aims to submit a Biologics License Application (BLA) for rilparencel in Q4 2027, with potential approval and commercial launch expected in 2028. ProKidney's focus remains on addressing the unmet medical needs of patients with advanced CKD and diabetes, a population at high risk of kidney failure.
