Why Is Penny Stock ProKidney Trading Higher On Tuesday?

ProKidney Corp. (NASDAQ:PROK) stock is trading higher on Tuesday, with a session volume of 39.8 million compared to the average volume of 1.12 million as per data from Benzinga Pro.

What happened: The chronic kidney disease (CKD)-focused company reported statistically significant and clinically meaningful positive topline results from the full Group 1 modified intent-to-treat (mITT) population of the Phase 2 REGEN-007 trial of rilparencel in patients with CKD and diabetes.

Rilparencel is an autologous cellular therapy. It is currently being evaluated in the ongoing Phase 3 REGEN-006 (PROACT 1) trial to demonstrate the therapy’s potential to preserve kidney function in patients with advanced CKD and type 2 diabetes.

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In Group 1 (n=24), kidney function stabilized after receiving rilparencel. The annual decline in estimated glomerular filtration rate (eGFR) slope improved by 78% from -5.8 mL/min/1.73m2 in the pre-injection period to -1.3 mL/min/1.73m2 in the period following the last rilparencel injection.

This 4.6 mL/min/1.73m2 per year difference was statistically significant (p<0.001) and clinically meaningful.

Of the 24 patients in Group 1, 15 (63%) met key Phase 3 PROACT 1 inclusion criteria, and similar efficacy results were observed in this subgroup compared to the full Group 1 results.

In Group 2 (n=25), the annual change in kidney function as measured by eGFR slope was -3.4 mL/min/1.73m2 in the pre-injection period versus -1.7 mL/min/1.73m2 in the period following the last rilparencel injection, resulting in an improvement of 50%, or 1.7 mL/min/1.73m2 per year. This difference was not statistically significant (p=0.085) but suggests evidence of a dose response.

Of the 25 patients in Group 2, 15 (60%) met the re-dosing trigger and received a second rilparencel injection. The median time between the first and second injections in these 15 patients was approximately 11 months.

No rilparencel-related serious adverse events were observed across all patients in the study who received at least one rilparencel injection (n=49). The safety profile was consistent with previously reported study results and comparable to a kidney biopsy.

The company announced that an FDA Type B meeting is scheduled for this summer to confirm ProKidney’s approach to using eGFR slope as the surrogate endpoint in the ongoing Phase 3 PROACT 1 study, aiming for accelerated approval.

Price Action: At the last check on Tuesday, PROK stock was up 56.6% at $0.95 during the premarket session.

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