WINSTON-SALEM, N.C., July 15, 2025 - ProKidney Corp. (Nasdaq: PROK), a leading late clinical-stage cellular therapeutics company, has announced a significant regulatory milestone with the U.S. Food and Drug Administration (FDA). The FDA has confirmed alignment on the accelerated approval pathway for ProKidney's rilparencel, an autologous cellular therapy aimed at preserving kidney function in patients with advanced chronic kidney disease (CKD) and type 2 diabetes. The ongoing Phase 3 PROACT 1 study, which has enrolled nearly half of the required patients, will serve as the basis for the accelerated approval analysis using the slope of estimated glomerular filtration rate (eGFR) as a surrogate endpoint. Topline data to support the application for accelerated approval is anticipated in Q2 2027. This alignment marks a critical step forward for ProKidney in addressing the needs of patients with high unmet clinical and societal demands.
免責聲明：投資有風險，本文並非投資建議，以上內容不應被視為任何金融產品的購買或出售要約、建議或邀請，作者或其他用戶的任何相關討論、評論或帖子也不應被視為此類內容。本文僅供一般參考，不考慮您的個人投資目標、財務狀況或需求。TTM對信息的準確性和完整性不承擔任何責任或保證，投資者應自行研究並在投資前尋求專業建議。