ProKidney Secures FDA Alignment On Accelerated Approval Pathway For Rilparencel

July 15, 2025 — 09:16 am EDT

Written by RTTNews.com for RTTNews

(RTTNews) - 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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ProKidney Secures FDA Alignment On Accelerated Approval Pathway For Rilparencel

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