TLDR
- ProKidney (PROK) stock surged 115% to over 660% after reporting positive Phase 2 REGEN-007 trial results for rilparencel in chronic kidney disease patients
- Group 1 patients showed 78% improvement in annual kidney function decline with statistically meaningful results
- No serious adverse events were observed during the trial, maintaining a safety profile comparable to kidney biopsy
- The company plans to submit full results to American Society of Nephrology’s 2025 Kidney Week as a late-breaking clinical trial
- Stock is trading at roughly 740% above its year-to-date low set in April despite remaining a penny stock with $177 million market cap
ProKidney stock experienced a dramatic surge Tuesday morning, climbing as much as 660% after the biotech company announced positive results from its Phase 2 REGEN-007 trial. The late clinical-stage cellular therapeutics company reported that its candidate treatment rilparencel showed promising results in patients with chronic kidney disease and diabetes.
The trial evaluated 49 patients who received at least one rilparencel injection across two treatment groups. Group 1 replicated the dosing schedule of the company’s ongoing Phase 3 PROACT 1 study, with patients receiving two scheduled injections approximately three months apart.
Results from Group 1 showed a 78% improvement in annual kidney function decline following treatment. The annual decline in estimated glomerular filtration rate (eGFR) slope improved from -5.8 mL/min/1.73m² in the pre-injection period to -1.3 mL/min/1.73m² after the last rilparencel injection.
This represents a statistically meaningful difference of 4.6 mL/min/1.73m² per year. Group 2, which tested an exploratory dosing regimen, showed a 50% improvement in kidney function decline, suggesting evidence of a dose response, though this difference was not statistically meaningful.
Safety remained a key focus throughout the trial period. No rilparencel-related serious adverse events were observed in the study, with the safety profile consistent with previously reported results and comparable to a kidney biopsy.
Stock Performance and Market Response
The stock’s meteoric rise pushed ProKidney’s year-to-date performance to roughly 740% above its April low. The company maintains a market cap of just $177 million, keeping it in penny stock territory despite the dramatic price movement.
Trading volume surged as investors responded to the trial news. The positive mid-stage data clears the path for rilparencel to advance into Phase 3 evaluation and eventually attempt to secure FDA approval.
ProKidney CEO Bruce Culleton expressed encouragement about the results. “We are very encouraged by the REGEN-007 topline results that demonstrated a robust improvement in eGFR slope following treatment with rilparencel in Group 1 as well as evidence of a dose response in Group 2,” he said.
Regulatory Path Forward
The company plans to submit the full results from REGEN-007 to the American Society of Nephrology’s 2025 Kidney Week as a late-breaking clinical trial. ProKidney is also preparing for an upcoming FDA Type B meeting to confirm its approach to eGFR slope as a surrogate endpoint for accelerated approval.
Wall Street analysts maintain a “Moderate Buy” consensus rating on PROK shares. However, the mean price target of $4.33 sits below the stock’s current trading price following Tuesday’s surge.
The biotech remains a pre-revenue company relying on continued positive trial updates and regulatory approvals. Penny stocks typically suffer from low liquidity and high volatility, making them subject to sharp price swings and speculative activity.
ProKidney’s focus on chronic kidney disease positions the company as a potential player in renal regenerative medicine. The REGEN-007 trial results represent a milestone for the company’s drug development pipeline and future regulatory submissions.
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