ProKidney plans to seek FDA accelerated approval for its kidney disease therapy using eGFR slope data by mid-2027.
ProKidney Corp. (NASDAQ:PROK) is advancing rilparencel, its cell therapy for chronic kidney disease in type 2 diabetes patients, toward accelerated FDA approval. The company expects to complete enrollment for its PROACT 1 late-stage trial by mid-2026, with key kidney-function results due in Q2 2027. The FDA has agreed to use eGFR slope—a measure of kidney function decline—as the primary endpoint for approval.
Earlier Phase 2 data from the REGEN-007 study showed a 4.6 mL/min/1.73m² improvement in annual kidney-function decline for one patient group. ProKidney ended Q1 with $224.9 million in cash, projecting funding through mid-2027.