Fortress Biotech: FDA, CUTX-101 NDA에 대한 PDUFA 날짜를 2026년 1월 14일로 설정

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.

핵심 사실

제출: 2025년 12월 15일 PM 01:30
이벤트: PDUFA 날짜 확정
방향: 긍정적
기업: FBIOFortress
자산: CUTX-101
출처: SEC 8-K
신뢰도: 출처 확인
캘린더: FDA 심사 결정 (PDUFA) · 2026년 1월 14일 · 보완요구서한 (CRL)

출처 발췌

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