{"schema_version":"secwatch.filing_event.v1","accession":"0001193125-26-413177","form_type":"8-K","ticker":"BNTC","cik":"0001808898","company_name":"Benitec Biopharma Inc.","filed_at":"2026-10-05T12:08:08+00:00","discovered_at":"2026-10-05T12:10:00.151617+00:00","generated_at":"2026-10-12T14:45:27.626160+00:00","sec_items":["7.01","9.01"],"event_type":"regulatory","sentiment":"neutral","materiality_score":0.45,"calibrated_materiality_score":0.45,"confidence":"high","headline":"Benitec: FDA requests more BB-301 data; pivotal design due 1Q 2027, enrollment mid-2027","bullets":["FDA formal feedback after a 3Q 2026 Type C meeting asked Benitec for additional available data, including results from the company-sponsored OPMD Natural History Study.","Benitec expects to confirm the final design of the open-label, single-arm BB-301 pivotal study in 1Q 2027; patient enrollment planned to begin mid-2027, with timelines 'on track'.","Interim Phase 1b/2a data to be presented as a late-breaking poster at ESGCT in Hamburg, Oct 27-30, 2026: 12-month follow-up for all six Cohort 1 patients, interim data for three Cohort 2 patients.","CEO Jerel A. Banks said the requested data will go to the FDA 'in the coming weeks'; goal is BB-301 as the first approved disease-modifying therapy for OPMD-related dysphagia."],"urls":{"canonical":"https://secwatch.observer/filing/0001193125-26-413177","json":"https://secwatch.observer/filing/0001193125-26-413177.json","markdown":"https://secwatch.observer/filing/0001193125-26-413177.md","text":"https://secwatch.observer/filing/0001193125-26-413177.txt","edgar_index":"https://www.sec.gov/Archives/edgar/data/1808898/000119312526413177/0001193125-26-413177-index.htm","edgar_primary_document":"https://www.sec.gov/Archives/edgar/data/1808898/000119312526413177/bntc-20261005.htm"},"model":{"generated_by":"deepseek-v4.1-flash:cloud@v2","generated_at":"2026-10-12T14:45:27.626160+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"}