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Investing.com -- ProKidney Corp. (NASDAQ:PROK) stock initially fell 11% in premarket trading after the company announced alignment with the FDA on the accelerated approval pathway for its kidney disease treatment rilparencel. Shares later pared the declined to down 3%.
The Winston-Salem, North Carolina-based company said the FDA confirmed that estimated glomerular filtration rate (eGFR) slope is an acceptable surrogate endpoint for accelerated approval of rilparencel in patients with chronic kidney disease (CKD) and type 2 diabetes. The agency also confirmed that the ongoing Phase 3 PROACT 1 study can be used for both accelerated and full approval.
ProKidney reported that nearly half of the patients required for the accelerated approval analysis using eGFR slope have been enrolled. The company anticipates topline data to support an application for accelerated approval in the second quarter of 2027.
According to the company, the FDA agreed that a rilparencel effect size of at least 1.5 mL/min/1.73m²/year improvement versus sham controls would demonstrate acceptable efficacy in patients receiving standard care therapies.
"We are very encouraged by the FDA’s support of the accelerated approval pathway for rilparencel using eGFR slope, marking a critical regulatory milestone for ProKidney," said Bruce Culleton, M.D., CEO of ProKidney.
The company said it will provide updated guidance on the expected timing of the confirmatory readout for full approval in the first half of 2026. Rilparencel previously received Regenerative Medicine Advanced Therapy (RMAT) designation from the FDA.
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