{"schema_version":"secwatch.filing_event.v1","accession":"0001193125-23-174479","form_type":"8-K","ticker":"BNTC","cik":"0001808898","company_name":"Benitec Biopharma Inc.","filed_at":"2023-06-26T23:59:59+00:00","discovered_at":"2026-05-14T18:03:40.707775+00:00","generated_at":"2026-06-13T17:12:44.416350+00:00","sec_items":["7.01","9.01"],"event_type":"regulatory","sentiment":"positive","materiality_score":0.75,"calibrated_materiality_score":0.75,"confidence":"high","headline":"Benitec Biopharma receives FDA IND clearance for BB-301 gene therapy for OPMD","bullets":["FDA cleared IND for BB-301, a silence-and-replace gene therapy for Oculopharyngeal Muscular Dystrophy (OPMD).","OPMD affects ~15,000 patients in US, Canada, Western Europe, and Israel; no approved therapies currently.","First subject dosing expected in H2 2023 after rollover from ongoing Natural History study (13 subjects enrolled).","Interim safety and efficacy data from Phase 1b/2a study to be reported every ~90 days post-dosing.","BB-301 designed to treat OPMD-related dysphagia, a life-threatening swallowing disorder."],"urls":{"canonical":"https://secwatch.observer/filing/0001193125-23-174479","json":"https://secwatch.observer/filing/0001193125-23-174479.json","markdown":"https://secwatch.observer/filing/0001193125-23-174479.md","text":"https://secwatch.observer/filing/0001193125-23-174479.txt","edgar_index":"https://www.sec.gov/Archives/edgar/data/1808898/000119312523174479/0001193125-23-174479-index.htm","edgar_primary_document":"https://www.sec.gov/Archives/edgar/data/1808898/000119312523174479/d516975d8k.htm"},"model":{"generated_by":"deepseek-v4-flash:cloud@v2","generated_at":"2026-06-13T17:12:44.416350+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"}