ProKidney confirms mid-2026 Phase 3 enrollment completion, Q2 2027 pivotal results expected

Filed May 15, 2026 · Period ending May 15, 2026 · ~1 min read

Key Changes

• high

  Phase 3 PROACT 1 trial enrollment on track to complete mid-2026, with pivotal topline results expected Q2 2027. This timeline determines when ProKidney could seek FDA approval for rilparencel in chronic kidney disease.

  Item 7.01 verify on EDGAR →
• high

  FDA agreed 1.5 mL/min/1.73m² improvement in kidney function decline would support approval under RMAT designation. Trial powered at 80% to detect this threshold, reducing regulatory uncertainty about what constitutes success.

  Item 7.01 verify on EDGAR →
• medium

  Phase 2 data showed 4.6 mL/min/1.73m² improvement, exceeding the 1.5 FDA threshold by 3x. While promising context, Phase 2 results don't guarantee Phase 3 outcomes.

  Item 7.01 verify on EDGAR →