ProKidney is a late-stage clinical biotech focused entirely on a single product: rilparencel, an autologous cell therapy designed to slow the progression of chronic kidney disease (CKD) in patients with type 2 diabetes. The therapy works by extracting a small biopsy from the patient's own kidney, expanding a specific population of kidney cells at ProKidney's Winston-Salem manufacturing facility, and injecting the resulting product back into the patient's kidneys via two minimally invasive outpatient procedures roughly three months apart. Because rilparencel uses the patient's own cells, it avoids the lifelong immunosuppression required with donor transplants. ProKidney's target population is adults with moderate to severe CKD (Stage 3b and Stage 4) and type 2 diabetes. The company has no approved products and no revenue; it is entirely focused on advancing rilparencel through its ongoing Phase 3 trial (PROACT 1), which targets ~470 patients across ~80 sites in the U.S., Mexico, and Taiwan. The FDA has confirmed that annualized eGFR slope (a measure of kidney function decline) can serve as the surrogate endpoint for accelerated approval, with topline data expected in Q2 2027. Completed Phase 2 data showed an 78% improvement in annual eGFR decline in the dosing group replicating the Phase 3 schedule. If approved, rilparencel would be a personalized, per-patient manufactured therapy — a complex and costly model, with each dose taking approximately 12 weeks to produce — and would likely be priced as a one-time or limited-course treatment.