---
schema_version: "secwatch.filing_event.v1"
accession: "0001558370-24-016294"
form_type: "8-K"
ticker: "FBIO"
cik: "0001429260"
company_name: "Fortress Biotech, Inc."
filed_at: "2024-12-16T23:59:59+00:00"
generated_at: "2026-05-29T02:51:00.547286+00:00"
event_type: "regulatory"
sentiment: "positive"
materiality_score: 0.85
calibrated_materiality_score: 0.85
confidence: "high"
source: SEC EDGAR
---

# FDA approves Fortress subsidiary Checkpoint's UNLOXCYT for advanced cSCC

## Summary
- FDA approved UNLOXCYT (cosibelimab-ipdl) for metastatic or locally advanced cutaneous squamous cell carcinoma (cSCC) in adults not candidates for curative surgery/radiation.
- UNLOXCYT is the first and only PD-L1 blocking antibody approved for this indication.
- Approval based on objective response rates and duration of response from Study CK-301-101 (NCT03212404).
- Checkpoint Therapeutics is a majority-controlled subsidiary of Fortress Biotech, Inc.

## SEC filing metadata
- accession: 0001558370-24-016294
- form_type: 8-K
- ticker: FBIO
- cik: 0001429260
- company_name: Fortress Biotech, Inc.
- filed_at: 2024-12-16T23:59:59+00:00
- event_type: regulatory
- sentiment: positive
- materiality_score: 0.85
- calibrated_materiality_score: 0.85
- confidence: high
- sec_items: 8.01
- EDGAR index: https://www.sec.gov/Archives/edgar/data/1429260/000155837024016294/0001558370-24-016294-index.htm
- EDGAR primary document: https://www.sec.gov/Archives/edgar/data/1429260/000155837024016294/fbio-20241213x8k.htm

## Machine-readable alternates
- HTML: https://secwatch.observer/filing/0001558370-24-016294
- JSON: https://secwatch.observer/filing/0001558370-24-016294.json
- Plain text: https://secwatch.observer/filing/0001558370-24-016294.txt

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