ProKidney Corp. (PROK) Tuesday said it has secured alignment with the U.S. Food and Drug Administration (FDA) on the accelerated approval pathway for rilparencel.
The FDA confirmed that the slope of estimated glomerular filtration rate (eGFR) in patients from the ongoing Phase 3 PROACT 1 study can serve as the surrogate endpoint and primary basis for a Biologics License Application (BLA) submission of rilparencel under the accelerated approval pathway.
Rilparencel has received Regenerative Medicine Advanced Therapy (RMAT) designation and currently is being evaluated in the ongoing Phase 3 REGEN-006 study.
ProKidney anticipates topline data readout of eGFR slope as the surrogate endpoint to support an application for accelerated approval in the second quarter of 2027.
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May 01, 2026 15:54 ET Central banks dominated the economics news flow this week with almost all major ones announcing their latest policy decisions and many boosted expectations for a rate hike in June. In other news, several countries released the preliminary data for first quarter economic growth. In the U.S., comments by Fed Chair Jerome Powell were also in focus as his term ends this month.