Fortress Biotech, Inc. 8-K

What Happened
Fortress Biotech, Inc. announced on January 13, 2026 that the U.S. Food and Drug Administration approved ZYCUBO® (copper histidinate, formerly CUTX-101) for the treatment of Menkes disease in pediatric patients. The company reported that a Rare Pediatric Disease Priority Review Voucher (PRV) was issued in connection with the approval and will be transferred to Cyprium Therapeutics, Inc., a majority‑owned subsidiary of Fortress. The company attached a press release to the Form 8‑K.

Key Details

• FDA approval date and Form 8‑K filing: January 13, 2026.
• Product: ZYCUBO® (copper histidinate), formerly known as CUTX-101.
• A Rare Pediatric Disease Priority Review Voucher (PRV) was issued and will be transferred to Cyprium Therapeutics, Inc. (majority‑owned subsidiary).
• Fortress furnished a press release as Exhibit 99.1 to the Form 8‑K.

Why It Matters
FDA approval creates a path for commercial availability of ZYCUBO for pediatric Menkes disease, which can generate revenue and advance Fortress’s clinical-to-commercial progress. The issued PRV is a transferable regulatory asset that historically can be used to accelerate FDA review of another product or be monetized, and transferring it to Cyprium moves that asset to the company’s majority‑owned subsidiary. Investors should view this as a regulatory and strategic milestone for Fortress and its subsidiary operations; financial impacts (timing and magnitude) were not quantified in the 8‑K.