{"schema_version":"secwatch.filing_event.v1","accession":"0001558370-25-000025","form_type":"8-K","ticker":"FBIO","cik":"0001429260","company_name":"Fortress Biotech, Inc.","filed_at":"2025-01-06T23:59:59+00:00","discovered_at":"2026-05-14T18:03:03.607939+00:00","generated_at":"2026-05-28T10:20:21.380194+00:00","sec_items":["8.01"],"event_type":"other_material","sentiment":"positive","materiality_score":0.65,"calibrated_materiality_score":0.65,"confidence":"high","headline":"FDA accepts Cyprium's NDA for CUTX-101 for priority review; action date June 30, 2025","bullets":["FDA granted priority review to CUTX-101 (Copper Histidinate) NDA for treating Menkes disease.","Target PDUFA action date is June 30, 2025; Sentynl (Zydus Group) will commercialize upon approval.","Cyprium retains any Priority Review Voucher and is eligible for up to $129M in milestones plus royalties.","Fortress Biotech owns ~76% of Cyprium, founded in 2017."],"urls":{"canonical":"https://secwatch.observer/filing/0001558370-25-000025","json":"https://secwatch.observer/filing/0001558370-25-000025.json","markdown":"https://secwatch.observer/filing/0001558370-25-000025.md","text":"https://secwatch.observer/filing/0001558370-25-000025.txt","edgar_index":"https://www.sec.gov/Archives/edgar/data/1429260/000155837025000025/0001558370-25-000025-index.htm","edgar_primary_document":"https://www.sec.gov/Archives/edgar/data/1429260/000155837025000025/fbio-20250106x8k.htm"},"model":{"generated_by":"deepseek-v4-flash:cloud@v2","generated_at":"2026-05-28T10:20:21.380194+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"}