原始来源记录
决策级完整回复函 (CRL)
Fortress Biotech：FDA就CUTX-101 NDA发出CRL
FDA就CUTX-101 NDA发出完整回复函，指出生产设施存在cGMP缺陷。CRL未指出任何疗效或安全性数据缺陷。Sentynl（现负责开发的合作伙伴）计划解决这些问题并重新提交NDA。
关键事实
来源摘录
EX-99 2 fbio-20251001xex99.htm EX-99 Exhibit 99.1 Fortress Biotech and Cyprium Therapeutics Announce an Update on the NDA for CUTX-101 Miami, FL – October 1, 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 issued a Complete Response Letter (“CRL”) relating to the New Drug Application (“NDA”) for CUTX-101 (copper histidinate), intended to treat Menkes disease in pediatric patients. In December 2023, Sentynl Therapeutics, Inc. (“Sentynl”), a U.S.-based biopharmaceutical company wholly-owned by Zydus Lifesciences, Ltd. (“Zydus Group”) assumed full responsibility for the development and commercialization of CUTX-101 from Cyprium. Cy