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Investing.com - BofA Securities has reiterated its Underperform rating and $1.00 price target on ProKidney Corp. (NASDAQ:PROK) following the company’s announcement of topline Phase 2 results for its REACT cell therapy for chronic kidney disease (CKD). According to InvestingPro data, the company maintains a strong balance sheet with more cash than debt, though it’s currently burning through cash at a concerning rate.
ProKidney shares surged approximately 600% after the data update, according to BofA Securities analyst notes. The company released the results in a press release but did not hold an investor call to discuss the findings. InvestingPro analysis indicates the stock remains significantly below its 52-week high, with a current market capitalization of $177.5 million. The stock’s current Fair Value assessment suggests it may be overvalued at these levels.
BofA Securities cited several concerns that informed its cautious stance, including the REGEN-007 study’s lack of a sham comparator. The firm noted that supportive data for REACT has been limited to open-label data cuts on a variable clinical measure known as eGFR.
The research firm also questioned the contribution of group 1 patients matching Phase 3 study enrollment criteria versus healthier study subjects, and expressed a need for clarity on the regulatory pathway forward.
BofA Securities maintained its Underperform rating based on perceived trial risk, concerns that the timeline to Phase 3 could exceed capital runway, regulatory uncertainty, and a potential end-market that "may prove niche absent highly compelling data." Detailed data from the study is likely pending until a medical meeting in the second half of 2025. InvestingPro subscribers can access 12 additional investment tips and comprehensive financial metrics to better evaluate PROK’s investment potential.
In other recent news, ProKidney Corp. reported positive results from its Phase 2 REGEN-007 trial, which assessed the effectiveness of rilparencel in patients with chronic kidney disease and diabetes. The trial revealed a statistically significant 78% improvement in kidney function decline for Group 1, with the estimated glomerular filtration rate (eGFR) slope improving from -5.8 to -1.3 mL/min/1.73m². Group 2 showed a 50% improvement, although this was not statistically significant. Additionally, ProKidney completed its redomestication from the Cayman Islands to Delaware, a move approved by shareholders and effective from July 1. The company assured that this change will not affect its day-to-day operations. Meanwhile, BofA Securities downgraded ProKidney’s stock to Underperform, citing a reduced sales outlook for its product candidate REACT and a more conservative peak sales projection of $900 million. The downgrade also reflects concerns over the competitive landscape and the timeline for Phase 3 data, expected in the third quarter of 2027. ProKidney plans to submit the full results of the REGEN-007 trial to the American Society of Nephrology’s 2025 Kidney Week as a late-breaking clinical trial.
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