原始来源记录
重大PDUFA 日期确定
Fortress Biotech：FDA 为 CUTX-101 NDA 设定 2026 年 1 月 14 日 PDUFA 日期
FDA 已受理 CUTX-101 NDA 的 1 类重新提交，并指定新的 PDUFA 目标行动日期为 2026 年 1 月 14 日。2025 年 9 月 30 日发出的 CRL 仅限于生产现场 cGMP 观察；未提及任何疗效或安全性缺陷。
关键事实
来源摘录
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