ProKidney Soars 29.27% on FDA Milestone for CKD Therapy

On July 15, 2025, ProKidney's stock surged by 29.27% in pre-market trading, reflecting significant investor optimism and market confidence in the company's recent developments.

ProKidney has achieved a pivotal regulatory milestone by securing alignment with the FDA on the accelerated approval pathway for rilparencel, its autologous cellular therapy for chronic kidney disease (CKD) patients with type 2 diabetes. The FDA confirmed that the slope of estimated glomerular filtration rate (eGFR) from the ongoing Phase 3 PROACT 1 trial can serve as the surrogate endpoint for accelerated approval. This agreement provides a clear efficacy threshold of at least 1.5 mL/min/1.73m2/year improvement versus controls, significantly derisking rilparencel's regulatory journey.

The PROACT 1 trial is designed to support both accelerated and full approval, streamlining the development timeline and reducing costs. This dual-purpose design is particularly efficient and reflects the FDA's recognition of rilparencel's potential importance for CKD patients with type 2 diabetes. The trial has enrolled nearly half of the required patients for accelerated approval analysis, with topline data expected in Q2 2027.

ProKidney's RMAT designation further validates the regulatory importance of rilparencel, as this designation is reserved for regenerative medicine therapies showing preliminary clinical evidence of addressing unmet medical needs for serious conditions. This designation provides enhanced interaction with the FDA and eligibility for priority review, offering a well-defined path to potential market entry for this autologous cellular therapy targeting the substantial chronic kidney disease market.