{"schema_version":"secwatch.filing_event.v1","accession":"0001104659-25-066520","form_type":"8-K","ticker":"MBIO","cik":"0001680048","company_name":"MUSTANG BIO, INC.","filed_at":"2025-07-09T23:59:59+00:00","discovered_at":"2026-05-14T18:02:44.620568+00:00","generated_at":"2026-05-18T08:53:59.113257+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":"Mustang Bio gets FDA Orphan Drug Designation for MB-101 CAR T-cell therapy in astrocytomas and glioblastoma","bullets":["FDA granted Orphan Drug Designation to MB-101 for recurrent diffuse/anaplastic astrocytoma and glioblastoma.","Designation provides tax credits, fee waivers, and potential 7-year market exclusivity upon approval.","Phase 1 trial showed 50% stable disease or better; two complete responses lasting 7.5 and 66+ months.","Preclinical data support combining MB-101 with oncolytic virus MB-108 to improve efficacy.","Company notes development of MB-109 program is contingent on raising additional funding."],"urls":{"canonical":"https://secwatch.observer/filing/0001104659-25-066520","json":"https://secwatch.observer/filing/0001104659-25-066520.json","markdown":"https://secwatch.observer/filing/0001104659-25-066520.md","text":"https://secwatch.observer/filing/0001104659-25-066520.txt","edgar_index":"https://www.sec.gov/Archives/edgar/data/1680048/000110465925066520/0001104659-25-066520-index.htm","edgar_primary_document":"https://www.sec.gov/Archives/edgar/data/1680048/000110465925066520/tm2520081d1_8k.htm"},"model":{"generated_by":"deepseek-v4-flash:cloud@v2","generated_at":"2026-05-18T08:53:59.113257+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"}