フォートレス・バイオテック:FDAがCUTX-101のNDAに対しPDUFA日を2026年1月14日に設定

FDA accepted the Class 1 resubmission of the CUTX-101 NDA and assigned a new PDUFA target action date of January 14, 2026. The CRL issued on September 30, 2025 was limited to manufacturing-site cGMP observations; no efficacy or safety deficiencies were cited.

主要事実

提出: 2025年12月15日 13:30
イベント: PDUFA 日設定
方向: ポジティブ
企業: FBIOFortress
アセット: CUTX-101
出典: SEC 8-K
信頼度: 出典あり
カレンダー: FDA 審査決定 (PDUFA) · 2026年1月14日 · 審査完了報告書 (CRL)

出典の抜粋

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

SEC 8-K