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Investing.com - ProKidney Corp. (NASDAQ:PROK) shares skyrocketed over 500% on Tuesday after the company released positive topline results from its Phase 2 REGEN-007 study evaluating rilparencel in patients with diabetes and chronic kidney disease. The surge marks a dramatic reversal from the stock’s previous 72% decline over the past year, according to InvestingPro data.
Citi raised its price target on ProKidney to $9.00 from $6.00 while maintaining a Buy rating, citing trial data that exceeded both analyst and management expectations. The investment bank increased its probability of success estimate by 10% to 60%. InvestingPro data shows the company maintains a strong liquidity position with a current ratio of 11x, though it is currently not profitable.
The REGEN-007 study demonstrated statistically significant efficacy on stabilization of estimated glomerular filtration rate (eGFR) slope in Group 1, where both kidneys were injected with the treatment. This endpoint may support accelerated approval in Phase 3 pending FDA confirmation. The company’s solid cash position, exceeding its debt levels, provides runway for continued clinical development.Want deeper insights? InvestingPro subscribers have access to 14 additional ProTips and comprehensive financial metrics for PROK.
Citi noted that Group 1’s inclusion criteria and dosing regimen more closely resemble Phase 3 criteria compared to Group 2, where the second kidney was only injected upon re-dosing trigger. The FDA has already indicated that eGFR slope is an acceptable surrogate endpoint.
Full results with eGFR plots are expected to be presented at the American Society of Nephrology (ASN) conference, which will provide more comprehensive data to assess the significance of these initial findings.
In other recent news, ProKidney Corp. reported positive topline results from its Phase 2 REGEN-007 trial, showing statistically significant improvements in kidney function for patients with chronic kidney disease and diabetes. Group 1 of the trial demonstrated a 78% improvement in the annual decline of estimated glomerular filtration rate (eGFR), while Group 2 showed a 50% improvement, though not statistically significant. No serious adverse events related to the treatment were observed. ProKidney plans to submit the full results to the American Society of Nephrology’s 2025 Kidney Week. Meanwhile, BofA Securities has downgraded ProKidney from Neutral to Underperform, citing a reduced sales outlook for its REACT therapy. The firm lowered its price target from $3.00 to $1.00 per share, reflecting a more conservative peak sales projection of $900 million. Additionally, ProKidney completed its redomestication from the Cayman Islands to Delaware, a move approved by shareholders. The transition is not expected to impact daily operations, and trading under the new structure has commenced.
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