ProKidney Secures FDA Accelerated Path for Kidney Therapy; Shares Surge

ProKidney Corp. said the U.S. Food and Drug Administration has agreed that the slope of estimated glomerular filtration rate measured in its ongoing Phase 3 PROACT 1 study can serve as the surrogate endpoint for accelerated approval of the company’s autologous cellular therapy, rilparencel, in patients with chronic kidney disease and type 2 diabetes. The agency also confirmed that the same trial may act as the confirmatory study for full approval. Nearly half of the 685 patients targeted for the accelerated-approval analysis have been enrolled, and ProKidney expects topline eGFR data in the second quarter of 2027. The regulatory alignment, disclosed 15 July, clears a path for ProKidney to file a biologics license application if the therapy shows at least a 1.5 mL/min/1.73 m² per year improvement over sham control. Shares of ProKidney jumped about 19% in U.S. pre-market trading following the announcement. Separately, Kairos Pharma reported positive safety results from an early-stage trial of its experimental prostate-cancer therapy, sending its stock up more than 50% before the opening bell.