ProKidney updates PROACT 1 timeline, reports $141.9 million cash position
The company said it now expects to enroll over 500 patients in its Phase 3 kidney disease trial, with topline data still slated for the second quarter of 2027.
ProKidney Corp. filed an updated investor presentation on November 9, 2026 detailing progress on its Phase 3 "PROACT 1" trial of rilparencel, an autologous cell therapy for advanced chronic kidney disease.
The company raised its enrollment target for the trial, saying it now anticipates enrolling over 500 patients, up from 470, driven by an acceleration in patient recruitment in mid-20261. Full enrollment is targeted for the first quarter of 2027, with a topline readout for the Phase 3 PROACT 1 surrogate endpoint of eGFR slope expected in the second quarter of 20271, supporting a potential accelerated approval pathway. The efficacy analysis set is expected to include approximately 320 patients1.
Beyond the surrogate endpoint readout, the company laid out a longer regulatory timeline: a BLA submission for accelerated approval of rilparencel in the first quarter of 20281, followed by BLA accelerated approval and commercial launch in the first half of 20291. A second readout, covering the trial's confirmatory composite time-to-event endpoint meant to support full approval, is expected in the second half of 20291.
On financials, the company reported that its cash and cash equivalents and marketable securities as of September 30, 2026 totaled $141.9 million1. The presentation separately stated the company's current cash is expected to support operating plans into mid-20271, with shares outstanding of 302,381,712 as of November 6, 2026 and coverage from 7 analyst firms.
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