Core Insights - ProKidney Corp. (PROK) shares surged 515% following positive phase II REGEN-007 study results for its drug rilparencel, aimed at treating diabetes and chronic kidney disease (CKD) [1][6] - The study demonstrated a statistically significant improvement in kidney function decline in one dosing group, with a 78% improvement in eGFR slope for Group 1 [3][6] Study Results - The REGEN-007 study randomized patients into two groups: Group 1 received two injections of rilparencel, while Group 2 received a single dose with a second only if kidney function declined [2] - The primary endpoint was the difference in annual estimated glomerular filtration rate (eGFR) slope, showing a 78% improvement in Group 1 and a 50% reduction in Group 2, although the latter did not reach statistical significance [3][6] Regulatory Outlook - ProKidney plans to seek FDA confirmation of eGFR slope as a surrogate endpoint in its ongoing Phase III trial, which could support accelerated approval based on the study results [7][8] - The company is scheduled to meet with the FDA to discuss the use of eGFR slope as the primary surrogate endpoint in the PROACT 1 study [8] Market Performance - Year-to-date, ProKidney's stock has increased by 121%, significantly outperforming the industry average growth of 4% [4] - The recent study results have raised the probability of success for rilparencel, contributing to the stock's dramatic increase [9] Company Ranking - ProKidney currently holds a Zacks Rank of 2 (Buy), indicating positive market sentiment [10]