---
schema_version: "secwatch.filing_event.v1"
accession: "0001558370-25-009264"
form_type: "8-K"
ticker: "FBIO"
cik: "0001429260"
company_name: "Fortress Biotech, Inc."
filed_at: "2025-07-16T23:59:59+00:00"
generated_at: "2026-05-18T06:13:16.764122+00:00"
event_type: "other_material"
sentiment: "negative"
materiality_score: 0.6
calibrated_materiality_score: 0.6
confidence: "high"
source: SEC EDGAR
---

# Fortress' former asset anselamimab fails primary endpoint in Phase III CARES study

## Summary
- AstraZeneca announced anselamimab did not achieve statistical significance on primary endpoint (ACM + CVH hierarchy) in Mayo stages IIIa/IIIb AL amyloidosis.
- Prespecified subgroup showed 'highly clinically meaningful improvement' in ACM and CVH; AZ plans further evaluation and regulatory discussions.
- Fortress remains eligible for up to ~$125M in milestones from the 2021 Caelum sale; outcome reduces likelihood of near-term payments.
- Anselamimab was well-tolerated; detailed results to be presented at future medical meeting.

## SEC filing metadata
- accession: 0001558370-25-009264
- form_type: 8-K
- ticker: FBIO
- cik: 0001429260
- company_name: Fortress Biotech, Inc.
- filed_at: 2025-07-16T23:59:59+00:00
- event_type: other_material
- sentiment: negative
- materiality_score: 0.6
- calibrated_materiality_score: 0.6
- confidence: high
- sec_items: 8.01
- EDGAR index: https://www.sec.gov/Archives/edgar/data/1429260/000155837025009264/0001558370-25-009264-index.htm
- EDGAR primary document: https://www.sec.gov/Archives/edgar/data/1429260/000155837025009264/fbio-20250716x8k.htm

## Machine-readable alternates
- HTML: https://secwatch.observer/filing/0001558370-25-009264
- JSON: https://secwatch.observer/filing/0001558370-25-009264.json
- Plain text: https://secwatch.observer/filing/0001558370-25-009264.txt

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