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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Business News
June 19, 2026 16:46 ET Major central banks continued to dominate the economic news flow this week too, led by the Federal Reserve, as they announced their latest policy decisions. The Federal Reserve policy session was in focus as it was the first to be led by the new chief Kevin Warsh. In Europe, central banks of the U.K. and Switzerland announced their rate decisions. In Asia, the Bank of Japan drew attention for its policy moves, while data out of China threw some light on the state of the economy.