ProKidney Corp. (NASDAQ:PROK) saw its stock drop 11% in early trading before recovering somewhat to close down 3%, after announcing alignment with the U.S. Food and Drug Administration on the accelerated approval framework for its kidney disease drug, rilparencel.
The North Carolina-based biotech confirmed that the FDA accepts the estimated glomerular filtration rate (eGFR) slope as a valid surrogate endpoint for expedited approval of rilparencel in patients with chronic kidney disease (CKD) and type 2 diabetes. The agency also agreed that data from the ongoing Phase 3 PROACT 1 trial can support both accelerated and full approval pathways.
ProKidney stated that nearly 50% of patients needed for the eGFR slope analysis are now enrolled, with topline results expected in Q2 2027, which would underpin an accelerated approval application.
The FDA reportedly indicated that an improvement in eGFR slope of at least 1.5 mL/min/1.73m² per year versus placebo would meet the efficacy threshold in patients receiving standard treatments.
Bruce Culleton, M.D., CEO of ProKidney, said, “The FDA’s endorsement of the accelerated approval pathway using eGFR slope is a pivotal regulatory milestone for our company and the advancement of rilparencel.”
The firm plans to release updated timelines for the confirmatory data needed for full approval in the first half of 2026. Rilparencel has previously been granted Regenerative Medicine Advanced Therapy (RMAT) status by the FDA.
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