{"schema_version":"secwatch.filing_event.v1","accession":"0001558370-25-000247","form_type":"8-K","ticker":"FBIO","cik":"0001429260","company_name":"Fortress Biotech, Inc.","filed_at":"2025-01-16T23:59:59+00:00","discovered_at":"2026-05-14T18:03:03.608166+00:00","generated_at":"2026-05-27T23:53:32.597944+00:00","sec_items":["8.01"],"event_type":"regulatory","sentiment":"neutral","materiality_score":0.6,"calibrated_materiality_score":0.6,"confidence":"high","headline":"FDA extends PDUFA date for Fortress subsidiary's NDA for CUTX-101 to Sep 30, 2025","bullets":["FDA extended target action date for CUTX-101 (Copper Histidinate) NDA to September 30, 2025.","Sentynl assumed full responsibility for CUTX-101 development and commercialization in Dec 2023.","Cyprium retains ownership of any Priority Review Voucher; eligible for up to $129M milestones plus royalties.","Fortress owns approximately 76% of Cyprium Therapeutics."],"urls":{"canonical":"https://secwatch.observer/filing/0001558370-25-000247","json":"https://secwatch.observer/filing/0001558370-25-000247.json","markdown":"https://secwatch.observer/filing/0001558370-25-000247.md","text":"https://secwatch.observer/filing/0001558370-25-000247.txt","edgar_index":"https://www.sec.gov/Archives/edgar/data/1429260/000155837025000247/0001558370-25-000247-index.htm","edgar_primary_document":"https://www.sec.gov/Archives/edgar/data/1429260/000155837025000247/fbio-20250116x8k.htm"},"model":{"generated_by":"deepseek-v4-flash:cloud@v2","generated_at":"2026-05-27T23:53:32.597944+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"}