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WINSTON-SALEM, N.C. - ProKidney Corp. (NASDAQ:PROK), a biotechnology company whose shares have surged over 130% in the past six months according to InvestingPro data, announced Tuesday that the U.S. Food and Drug Administration has confirmed estimated glomerular filtration rate (eGFR) slope can serve as a surrogate endpoint for accelerated approval of rilparencel, its cell therapy for chronic kidney disease (CKD) in patients with type 2 diabetes.
The FDA agreed that the ongoing Phase 3 PROACT 1 study can be used for both accelerated approval and as the confirmatory study for full approval. The agency indicated that a rilparencel effect size of at least 1.5 mL/min/1.73m²/year improvement versus sham controls would demonstrate efficacy. With a strong liquidity position and a current ratio of nearly 11x, InvestingPro data shows ProKidney is well-positioned to fund its clinical development programs.
ProKidney has enrolled nearly half of the patients required for the accelerated approval analysis and anticipates topline data to support a Biologics License Application in the second quarter of 2027.
"This alignment allows us to move forward with clarity and conviction as we advance enrollment in our pivotal Phase 3 PROACT 1 study," said Bruce Culleton, CEO of ProKidney, in the press release statement.
The PROACT 1 trial is evaluating rilparencel in patients with Stage 4 CKD (eGFR 20-30 mL/min/1.73m²) and late Stage 3b CKD (eGFR 30-35 mL/min/1.73m²) with accompanying albuminuria. The study plans to enroll approximately 685 subjects who will be randomized to receive either rilparencel injections or a sham procedure.
Rilparencel previously received Regenerative Medicine Advanced Therapy designation from the FDA. The therapy is being developed for a U.S. population that includes 1 to 2 million people with Stage 3b/4 CKD and diabetes.
The company stated it will provide updated guidance on the expected timing of the confirmatory readout in the first half of 2026. With analyst price targets ranging from $1 to $9 per share and 12 additional InvestingPro tips available, investors seeking deeper insights into ProKidney’s financial health and market position can access comprehensive analysis through the platform.
In other recent news, ProKidney Corp. has been in the spotlight following significant developments related to its Phase 2 REGEN-007 trial for rilparencel, a treatment for chronic kidney disease. Citi analysts raised their price target for ProKidney to $9 from $6, highlighting better-than-expected trial results that demonstrated statistically significant efficacy in stabilizing the estimated glomerular filtration rate (eGFR) slope in patients. The FDA has indicated that eGFR slope is an acceptable surrogate endpoint, which could support accelerated approval in Phase 3 trials. UBS also increased its price target to $8, citing promising data from the Phase 2 trial and maintaining a Buy rating. Guggenheim followed suit, raising its price target to $7 from $6, after consulting with experts who noted the clinical significance of the eGFR impact observed. However, BofA Securities maintained an Underperform rating with a $1 price target, expressing concerns over the trial’s lack of a sham comparator and regulatory uncertainties. ProKidney plans to provide further regulatory updates following discussions with the FDA, with full trial data expected at the American Society of Nephrology Meeting. These developments have captured the attention of both investors and analysts, as ProKidney continues to advance its clinical trials.
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