Fortress Biotech: Itinakda ng FDA ang PDUFA date na Enero 14, 2026 para sa NDA ng CUTX-101

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.

Mahahalagang fact

Na-file: Dis 15, 2025, 01:30 PM
Kaganapan: Naitakda ang petsa ng PDUFA
Direksyon: Positibo
Kumpanya: FBIOFortress Biotech
Asset: CUTX-101
Pinagmulan: SEC 8-K
Kumpiyansa: May source
Kalendaryo: Desisyon ng FDA (PDUFA) · Ene 14, 2026 · Complete response letter

Sipi mula sa source

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