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CUTX-101 · Fortress Biotech (FBIO)

Indication
Menkes disease in pediatric patients
Also known as
copper histidinate, Zycubo
CompanyFBIOFortress Biotech

Fortress Biotech Inc is a biopharmaceutical company. The firm is involved in the business of acquiring, developing, and commercializing pharmaceutical and biotechnology products. Its product portfolio encompasses Qbrexza, Accutane, Amzeeq, Zilxi, Targadox, and…

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On the calendar

14
Jan 2026
Jan 14, 2026
290 days ago
FBIOFortress Biotech

Fortress Biotech: FDA sets Jan 14 2026 PDUFA for CUTX-101 NDA

FDA decision (PDUFA)ApprovedSEC 8-K

Timeline

Newest first.

CUTX-101 · Fortress Biotech (FBIO) — FDA Timeline & Readiness Checklist | SimianX AI