{"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","discovered_at":"2026-05-14T18:02:43.971419+00:00","generated_at":"2026-05-18T06:13:16.764122+00:00","sec_items":["8.01"],"event_type":"other_material","sentiment":"negative","materiality_score":0.6,"calibrated_materiality_score":0.6,"confidence":"high","headline":"Fortress' former asset anselamimab fails primary endpoint in Phase III CARES study","bullets":["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."],"urls":{"canonical":"https://secwatch.observer/filing/0001558370-25-009264","json":"https://secwatch.observer/filing/0001558370-25-009264.json","markdown":"https://secwatch.observer/filing/0001558370-25-009264.md","text":"https://secwatch.observer/filing/0001558370-25-009264.txt","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"},"model":{"generated_by":"deepseek-v4-flash:cloud@v2","generated_at":"2026-05-18T06:13:16.764122+00:00"},"review":{"review_status":"machine_generated","human_reviewed":false,"corrected":false,"correction_note":null,"correction_timestamp":null,"superseded_by":null,"related_filings":[]},"source_grounded_claims":[],"license":"Source filings: public domain (SEC EDGAR). Summaries (headline + bullets): CC-BY-4.0; attribute https://secwatch.observer"}