Shares of ProKidney Corp. (NASDAQ: PROK) surged 515.00% on Tuesday to close at $3.73 after announcing promising clinical results, with the rally extending into Wednesday’s pre-market session. As of the latest check, PROK stock rose another 22.25% to reach $4.56. The sharp gains follow the release of statistically and clinically significant topline results from the Group 1 modified intent-to-treat (mITT) population in the Phase 2 REGEN-007 study.
Positive Clinical Milestone for Rilparencel
Rilparencel, an autologous cellular treatment intended for patients with type 2 diabetes and chronic kidney disease (CKD), was assessed in the REGEN-007 experiment. The treatment is intended to maintain kidney function and has been designated as a Regenerative Medicine Advanced Therapy (RMAT) by the U.S. FDA. It is currently under further evaluation in the ongoing Phase 3 REGEN-006 (PROACT 1) trial.
REGEN-007’s Group 1 results revealed a substantial improvement in eGFR slope—an important indicator of kidney function—following treatment with rilparencel. Additionally, a clear dose-response was observed in Group 2, lending further support to the treatment’s potential.
Strengthening Foundation for Phase 3 Trial
The favorable REGEN-007 data are expected to inform and reinforce the design of the ongoing Phase 3 PROACT 1 trial. Of the 24 patients in Group 1, 15 (63%) met the inclusion criteria for PROACT 1, and this subgroup showed efficacy results consistent with the broader Group 1 population. ProKidney intends to present the complete REGEN-007 findings as a late-breaking clinical trial at the American Society of Nephrology (ASN) 2025 Kidney Week.
Regulatory Pathway and Future Outlook
In order to validate the use of eGFR slope as a surrogate endpoint for expedited approval, ProKidney is getting ready for an impending FDA Type B meeting in the summer of 2025. In a Q4 2024 discussion, the FDA had already suggested that such a method may work. ProKidney wants to expedite rilparencel to address a key unmet need in patients with severe chronic kidney disease (CKD) and diabetes, with promising Phase 2 data in hand and regulatory clarity improving.