ProKidney is on track to complete enrollment of its Phase 3 PROACT-1 accelerated approval study by mid-2026, targeting a surrogate endpoint based on annualized eGFR slope. The trial is powered at 90% to detect a 1.75 mL/min/1.73 m² effect and 80% for a 1.5 mL/min/1.73 m² effect, with pivotal topline results expected in Q2 2027.

Peer-reviewed Phase 2 REGEN-007 data showed bilateral kidney injections of rilparencel were associated with a 4.6 mL/min/1.73 m² improvement in the annual decline of eGFR slope comparing post-injection to pre-injection periods. These findings underpin confidence in the design and potential efficacy of the PROACT-1 study.

Under its RMAT designation, ProKidney received FDA confirmation that an annual eGFR slope effect size of 1.5 mL/min/1.73 m² would satisfy efficacy requirements for accelerated approval. The FDA also agreed that the PROACT-1 surrogate endpoint can support both accelerated and confirmatory approval in a BLA submission.

At March 31, 2026, ProKidney held $224.9 million in cash, cash equivalents and marketable securities, sufficient to fund operations into mid-2027. R&D expenses rose to $33.8 million from $27.3 million year-over-year, while G&A costs fell to $11.3 million. Net loss before noncontrolling interest was $42.6 million, and 301.95 million shares were outstanding.