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WINSTON-SALEM - ProKidney Corp. (NASDAQ:PROK), currently trading at $0.61 with a market cap of $81 million, announced Tuesday that its Phase 2 REGEN-007 trial evaluating rilparencel in patients with chronic kidney disease (CKD) and diabetes showed statistically significant improvement in kidney function. According to InvestingPro data, the company maintains a strong liquidity position with a current ratio of 11x, though it faces significant cash burn challenges.
In the trial’s Group 1, patients who received two rilparencel injections (one in each kidney) experienced a 78% improvement in the annual decline of estimated glomerular filtration rate (eGFR). The eGFR slope improved from -5.8 mL/min/1.73m² in the pre-injection period to -1.3 mL/min/1.73m² after treatment, representing a 4.6 mL/min/1.73m² per year difference that was statistically significant (p
Group 2 patients, who received a single injection followed by a second only if kidney function worsened, showed a 50% improvement in annual eGFR decline, though this result was not statistically significant (p=0.085).
No rilparencel-related serious adverse events were observed in the study, according to the company. The safety profile was reported to be consistent with previous studies and comparable to a kidney biopsy.
The company plans to submit full results from the trial to the American Society of Nephrology’s 2025 Kidney Week as a late-breaking clinical trial.
ProKidney also announced an upcoming FDA Type B meeting this summer to confirm its approach to using eGFR slope as a surrogate endpoint in its ongoing Phase 3 PROACT 1 study for potential accelerated approval.
Rilparencel is an autologous cellular therapy that has received Regenerative Medicine Advanced Therapy designation from the FDA. The treatment is being developed for patients with Stage 3b/4 CKD and diabetes, a population that includes 1-2 million people in the U.S. While the company holds more cash than debt on its balance sheet, InvestingPro analysis reveals 12 additional key insights about ProKidney’s financial position and market outlook, available to subscribers.
The information in this article is based on a press release statement from ProKidney Corp.
In other recent news, ProKidney Corp. has completed its redomestication from the Cayman Islands to Delaware, effective July 1. This transition was approved by shareholders and resulted in the automatic conversion of Class A and Class B ordinary shares into corresponding common stock of the Delaware entity. ProKidney’s common stock will continue trading on the Nasdaq under the same ticker symbol, "PROK." Additionally, BofA Securities recently downgraded ProKidney from Neutral to Underperform, citing a reduced sales outlook for its product candidate, REACT. The firm’s revised peak sales projection for REACT is now $900 million, down from $1.8 billion, following discussions with nephrology experts about the competitive landscape. BofA expressed concerns about ProKidney’s ability to advance its Phase 3 data timeline and mentioned a financing overhang as a potential risk. The revised price target for ProKidney is now set at $1.00 per share, based on a discounted cash flow analysis. These developments highlight significant changes for ProKidney and present a mixed outlook for investors.
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