---
schema_version: "secwatch.filing_event.v1"
accession: "0001104659-25-120893"
form_type: "8-K"
ticker: "FBIO"
cik: "0001429260"
company_name: "Fortress Biotech, Inc."
filed_at: "2025-12-15T23:59:59+00:00"
generated_at: "2026-05-16T13:11:52.211022+00:00"
event_type: "regulatory"
sentiment: "positive"
materiality_score: 0.65
calibrated_materiality_score: 0.65
confidence: "high"
source: SEC EDGAR
---

# FDA accepts CUTX-101 NDA resubmission as Class 1; PDUFA date Jan 14, 2026

## Summary
- FDA accepted NDA resubmission for CUTX-101 (copper histidinate) for Menkes disease; new PDUFA target action date January 14, 2026.
- Prior complete response letter in Sept 2025 cited only cGMP manufacturing observations; no efficacy/safety deficiencies.
- Sentynl (Zydus unit) leads development/commercialization; Cyprium eligible for up to $129M milestones plus PRV if approved.
- CUTX-101 previously granted Priority Review; early treatment showed significant improvement in overall survival.

## SEC filing metadata
- accession: 0001104659-25-120893
- form_type: 8-K
- ticker: FBIO
- cik: 0001429260
- company_name: Fortress Biotech, Inc.
- filed_at: 2025-12-15T23:59:59+00:00
- event_type: regulatory
- sentiment: positive
- materiality_score: 0.65
- calibrated_materiality_score: 0.65
- confidence: high
- sec_items: 8.01, 9.01
- EDGAR index: https://www.sec.gov/Archives/edgar/data/1429260/000110465925120893/0001104659-25-120893-index.htm
- EDGAR primary document: https://www.sec.gov/Archives/edgar/data/1429260/000110465925120893/fbio-20251215x8k.htm

## Machine-readable alternates
- HTML: https://secwatch.observer/filing/0001104659-25-120893
- JSON: https://secwatch.observer/filing/0001104659-25-120893.json
- Plain text: https://secwatch.observer/filing/0001104659-25-120893.txt

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