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Investing.com -- ProKidney Corp (NASDAQ:PROK) stock jumped as high as 12% after the company announced that the U.S. Food and Drug Administration (FDA) has confirmed an accelerated approval pathway for its chronic kidney disease therapy, rilparencel.
The late clinical-stage cellular therapeutics company revealed that the FDA agreed that the slope of estimated glomerular filtration rate (eGFR) from its ongoing Phase 3 PROACT 1 trial can serve as the surrogate endpoint for a Biologics License Application submission under the accelerated approval pathway. The FDA specified that a rilparencel effect size of at least 1.5 mL/min/1.73m²/year improvement versus sham controls would demonstrate acceptable efficacy.
ProKidney expects topline data readout to support an application for accelerated approval in the second quarter of 2027. The company has already enrolled nearly half of the patients required for the accelerated approval analysis.
The FDA also confirmed that the ongoing Phase 3 PROACT 1 study may serve as the confirmatory study to support full approval of rilparencel based on the primary time-to-event composite endpoint specified in the protocol. ProKidney plans to provide updated guidance on the expected timing of the confirmatory readout in the first half of 2026.
Rilparencel is an autologous cellular therapy that previously received Regenerative Medicine Advanced Therapy designation from the FDA. The therapy is being evaluated for its potential to preserve kidney function in patients with advanced chronic kidney disease and type 2 diabetes.
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