{"schema_version":"secwatch.filing_event.v1","accession":"0001104659-25-095366","form_type":"8-K","ticker":"FBIO","cik":"0001429260","company_name":"Fortress Biotech, Inc.","filed_at":"2025-10-01T23:59:59+00:00","discovered_at":"2026-05-14T18:02:39.390492+00:00","generated_at":"2026-05-17T05:04:14.894124+00:00","sec_items":["8.01","9.01"],"event_type":"regulatory","sentiment":"negative","materiality_score":0.65,"calibrated_materiality_score":0.65,"confidence":"high","headline":"FDA issues Complete Response Letter for Fortress Biotech's CUTX-101 over manufacturing issues","bullets":["FDA issued CRL for CUTX-101 NDA to treat Menkes disease; cGMP deficiencies at the manufacturing facility.","No efficacy/safety deficiencies cited; CRL solely based on manufacturing observations at the facility.","Partner Sentynl expects to request FDA meeting and pursue resubmission promptly after facility's recent response.","Cyprium eligible for up to $129M in milestones plus a Rare Pediatric Disease PRV upon NDA approval.","NDA initially granted Priority Review; early treatment showed significant survival improvement in trials."],"urls":{"canonical":"https://secwatch.observer/filing/0001104659-25-095366","json":"https://secwatch.observer/filing/0001104659-25-095366.json","markdown":"https://secwatch.observer/filing/0001104659-25-095366.md","text":"https://secwatch.observer/filing/0001104659-25-095366.txt","edgar_index":"https://www.sec.gov/Archives/edgar/data/1429260/000110465925095366/0001104659-25-095366-index.htm","edgar_primary_document":"https://www.sec.gov/Archives/edgar/data/1429260/000110465925095366/fbio-20251001x8k.htm"},"model":{"generated_by":"deepseek-v4-flash:cloud@v2","generated_at":"2026-05-17T05:04:14.894124+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"}