ProKidney advances to late-stage with FDA accelerated approval pathway confirmed for rilparencel

Filed March 18, 2026 · Period ending December 31, 2025 · Compared to 10-K Mar 17, 2025 · ~2 min read

Key Changes

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  FDA confirmed in Q3 2025 that eGFR slope can serve as surrogate endpoint for accelerated approval, with PROACT 1 serving as both basis for accelerated approval and confirmatory study for full approval—significantly de-risking regulatory pathway.

  Business: FDA accelerated approval pathway verify on EDGAR →
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  REGEN-007 Phase 2 trial completed May 2025 showed 78% improvement in kidney function decline (p<0.001), with 85% improvement in patients meeting Phase 3 criteria. No rilparencel-related serious adverse events observed.

  Business: REGEN-007 results verify on EDGAR →
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  Phase 3 PROACT 1 surrogate endpoint data expected Q2 2027, confirmatory endpoint H2 2029. Protocol amended to focus on Stage 4 and late Stage 3b CKD patients, narrowing addressable market but likely improving trial success probability.

  Business: PROACT 1 timeline verify on EDGAR →