ProKidney Corp. announced positive topline results from its Phase 2 REGEN-007 trial evaluating rilparencel, a potential treatment for chronic kidney disease in patients with diabetes. The therapy showed statistically significant improvements in kidney function, representing a significant milestone for the biotechnology company's lead program.
Strong Phase 2 Results Drive Market Response
The REGEN-007 Phase 2 trial demonstrated that patients treated with rilparencel showed "robust improvement" in measures of chronic kidney disease and diabetes. According to Chief Executive Bruce Culleton, the data bolsters confidence in the design of the ongoing Phase 3 study.
The positive results led to extraordinary market activity, with ProKidney's stock surging 496.87 percent to $3.62 on Tuesday. Trading volume exploded to more than 327.3 million shares, compared with the full-day average of about 1.3 million shares. The stock was halted 45 times for volatility between 10:15 a.m. Eastern and the closing bell.
Regulatory Pathway and FDA Designation
Rilparencel has received FDA Regenerative Medicine Advanced Therapy (RMAT) designation, which provides enhanced regulatory support for promising regenerative medicine therapies. ProKidney is preparing for an upcoming FDA Type B meeting to discuss accelerated approval pathways for the treatment.
The company plans to submit the full REGEN-007 data for presentation at the 2025 ASN Kidney Week, providing the medical community with comprehensive results from the Phase 2 trial.
Phase 3 Development Timeline
ProKidney's Phase 3 PROACT 1 trial is currently ongoing, building on the positive Phase 2 results. Evercore ISI analyst Jonathan Miller noted that while the Phase 2 results were "very intriguing," questions remain about some nuances of the data heading into the Phase 3 trial.
Miller indicated that a readout on Phase 3 data could occur as early as the end of 2026, though it could be 18 months before comprehensive Phase 3 data is released. The analyst believes the Phase 3 trial in chronic kidney disease could be a "major catalyst in the kidney space."
Market Transformation
The dramatic stock movement transformed ProKidney from a penny stock with a market capitalization of about $178.55 million to a company valued at over $1 billion. The stock had closed at 61 cents on Monday, marking the 17th straight session with a close below $1, and the 46th sub-$1 close over the past 47 sessions.
Despite the positive Phase 2 results, Evercore's Miller maintained his in-line rating on the stock, citing remaining questions about the data that he "can't reconcile completely" as the company advances toward Phase 3 development.
