原始出處紀錄
重大PDUFA 日期確定
Fortress Biotech：FDA 將 CUTX-101 NDA 的 PDUFA 日期定為 2026 年 1 月 14 日
FDA 已受理 CUTX-101 NDA 的 Class 1 重新提交，並指定新的 PDUFA 目標行動日期為 2026 年 1 月 14 日。2025 年 9 月 30 日發出的 CRL 僅限於製造場地的 cGMP 觀察；未提及任何療效或安全性缺失。
關鍵事實
來源摘錄
EX-99 2 fbio-20251215xex99.htm EX-99 Exhibit 99.1 Fortress Biotech and Cyprium Therapeutics Announce FDA Acceptance of CUTX-101 NDA Resubmission New PDUFA Target Action Date of January 14, 2026 set by FDA Miami, FL – December 15, 2025 – Fortress Biotech, Inc. (Nasdaq: FBIO) (“Fortress”) and its majority-owned subsidiary, Cyprium Therapeutics, Inc. (“Cyprium”), today announced that the U.S. Food and Drug Administration (“FDA”) has accepted the resubmission of the New Drug Application (“NDA”) for CUTX-101 (copper histidinate), intended to treat Menkes disease in pediatric patients. The resubmission has been accepted as a Class 1 resubmission and as a result, the new Prescription Drug User Fee Act (PDUFA) target action date for the NDA is January 14, 2026. In December 2023, Sent