---
schema_version: "secwatch.filing_event.v1"
accession: "0001558370-25-000247"
form_type: "8-K"
ticker: "FBIO"
cik: "0001429260"
company_name: "Fortress Biotech, Inc."
filed_at: "2025-01-16T23:59:59+00:00"
generated_at: "2026-05-27T23:53:32.597944+00:00"
event_type: "regulatory"
sentiment: "neutral"
materiality_score: 0.6
calibrated_materiality_score: 0.6
confidence: "high"
source: SEC EDGAR
---

# FDA extends PDUFA date for Fortress subsidiary's NDA for CUTX-101 to Sep 30, 2025

## Summary
- FDA extended target action date for CUTX-101 (Copper Histidinate) NDA to September 30, 2025.
- Sentynl assumed full responsibility for CUTX-101 development and commercialization in Dec 2023.
- Cyprium retains ownership of any Priority Review Voucher; eligible for up to $129M milestones plus royalties.
- Fortress owns approximately 76% of Cyprium Therapeutics.

## SEC filing metadata
- accession: 0001558370-25-000247
- form_type: 8-K
- ticker: FBIO
- cik: 0001429260
- company_name: Fortress Biotech, Inc.
- filed_at: 2025-01-16T23:59:59+00:00
- event_type: regulatory
- sentiment: neutral
- materiality_score: 0.6
- calibrated_materiality_score: 0.6
- confidence: high
- sec_items: 8.01
- EDGAR index: https://www.sec.gov/Archives/edgar/data/1429260/000155837025000247/0001558370-25-000247-index.htm
- EDGAR primary document: https://www.sec.gov/Archives/edgar/data/1429260/000155837025000247/fbio-20250116x8k.htm

## Machine-readable alternates
- HTML: https://secwatch.observer/filing/0001558370-25-000247
- JSON: https://secwatch.observer/filing/0001558370-25-000247.json
- Plain text: https://secwatch.observer/filing/0001558370-25-000247.txt

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