“We’ve made tremendous progress in 2025, and July was a pivotal month for ProKidney (PROK) with the release of positive topline data from our Phase 2 REGEN-007 study and alignment with the FDA on the accelerated approval pathway for rilparencel using eGFR slope as the surrogate endpoint,” said Bruce Culleton, CEO of ProKidney. “We are now focused on maintaining enrollment momentum in the Phase 3 PROACT 1 study and preparing for a late-breaking submission of Phase 2 REGEN-007 data at ASN Kidney Week in November. Each step brings us closer to our goal of delivering a novel treatment option to patients with diabetes and advanced CKD, a population where there remains high unmet clinical need.”
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