---
schema_version: "secwatch.filing_event.v1"
accession: "0001558370-25-000025"
form_type: "8-K"
ticker: "FBIO"
cik: "0001429260"
company_name: "Fortress Biotech, Inc."
filed_at: "2025-01-06T23:59:59+00:00"
generated_at: "2026-05-28T10:20:21.380194+00:00"
event_type: "other_material"
sentiment: "positive"
materiality_score: 0.65
calibrated_materiality_score: 0.65
confidence: "high"
source: SEC EDGAR
---

# FDA accepts Cyprium's NDA for CUTX-101 for priority review; action date June 30, 2025

## Summary
- FDA granted priority review to CUTX-101 (Copper Histidinate) NDA for treating Menkes disease.
- Target PDUFA action date is June 30, 2025; Sentynl (Zydus Group) will commercialize upon approval.
- Cyprium retains any Priority Review Voucher and is eligible for up to $129M in milestones plus royalties.
- Fortress Biotech owns ~76% of Cyprium, founded in 2017.

## SEC filing metadata
- accession: 0001558370-25-000025
- form_type: 8-K
- ticker: FBIO
- cik: 0001429260
- company_name: Fortress Biotech, Inc.
- filed_at: 2025-01-06T23:59:59+00:00
- event_type: other_material
- sentiment: positive
- materiality_score: 0.65
- calibrated_materiality_score: 0.65
- confidence: high
- sec_items: 8.01
- EDGAR index: https://www.sec.gov/Archives/edgar/data/1429260/000155837025000025/0001558370-25-000025-index.htm
- EDGAR primary document: https://www.sec.gov/Archives/edgar/data/1429260/000155837025000025/fbio-20250106x8k.htm

## Machine-readable alternates
- HTML: https://secwatch.observer/filing/0001558370-25-000025
- JSON: https://secwatch.observer/filing/0001558370-25-000025.json
- Plain text: https://secwatch.observer/filing/0001558370-25-000025.txt

This AI-assisted summary is a reading aid. Review the linked SEC EDGAR filing before relying on any specific claim.