{"schema_version":"secwatch.filing_event.v1","accession":"0001104659-25-120893","form_type":"8-K","ticker":"FBIO","cik":"0001429260","company_name":"Fortress Biotech, Inc.","filed_at":"2025-12-15T23:59:59+00:00","discovered_at":"2026-05-14T18:02:39.391096+00:00","generated_at":"2026-05-16T13:11:52.211022+00:00","sec_items":["8.01","9.01"],"event_type":"regulatory","sentiment":"positive","materiality_score":0.65,"calibrated_materiality_score":0.65,"confidence":"high","headline":"FDA accepts CUTX-101 NDA resubmission as Class 1; PDUFA date Jan 14, 2026","bullets":["FDA accepted NDA resubmission for CUTX-101 (copper histidinate) for Menkes disease; new PDUFA target action date January 14, 2026.","Prior complete response letter in Sept 2025 cited only cGMP manufacturing observations; no efficacy/safety deficiencies.","Sentynl (Zydus unit) leads development/commercialization; Cyprium eligible for up to $129M milestones plus PRV if approved.","CUTX-101 previously granted Priority Review; early treatment showed significant improvement in overall survival."],"urls":{"canonical":"https://secwatch.observer/filing/0001104659-25-120893","json":"https://secwatch.observer/filing/0001104659-25-120893.json","markdown":"https://secwatch.observer/filing/0001104659-25-120893.md","text":"https://secwatch.observer/filing/0001104659-25-120893.txt","edgar_index":"https://www.sec.gov/Archives/edgar/data/1429260/000110465925120893/0001104659-25-120893-index.htm","edgar_primary_document":"https://www.sec.gov/Archives/edgar/data/1429260/000110465925120893/fbio-20251215x8k.htm"},"model":{"generated_by":"deepseek-v4-flash:cloud@v2","generated_at":"2026-05-16T13:11:52.211022+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"}