ProKidney drops Phase III CKD study to focus on US market and save up to $175m
ProKidney is discontinuing its ex-US Phase III study for CKD cell therapy rilparencel to focus on the US market, saving $150m-$175m. The decision follows regulatory discussions and aims to expedite market entry in the US, where the therapy has RMAT designation.
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ProKidney is focusing on its phase 3 REGEN-006 (PROACT 1) trial for rilparencel in US patients with T2D and CKD, discontinuing PROACT 2 in Spain. The company anticipates expedited US approval via RMAT designation, with topline findings expected in Q3 2027. PROACT 1, modified to focus on stage 4 CKD and late stage 3b CKD with albuminuria, aims to accelerate US registration and commercial launch. Positive interim REGEN-007 data supports rilparencel's potential to preserve kidney function.
ProKidney is discontinuing its ex-US Phase III study for CKD cell therapy rilparencel to focus on the US market, saving $150m-$175m. The decision follows regulatory discussions and aims to expedite market entry in the US, where the therapy has RMAT designation.