{"schema_version":"secwatch.filing_event.v1","accession":"0001178913-22-003589","form_type":"8-K","ticker":"ENTXW","cik":"0001638097","company_name":"Entera Bio Ltd.","filed_at":"2022-10-06T23:59:59+00:00","discovered_at":"2026-05-14T18:03:51.525439+00:00","generated_at":"2026-06-23T05:04:00.598262+00:00","sec_items":["8.01"],"event_type":"regulatory","sentiment":"positive","materiality_score":0.75,"calibrated_materiality_score":0.75,"confidence":"high","headline":"Entera Bio receives FDA agreement that single Phase 3 study could support NDA for EB613","bullets":["FDA agreed single Phase 3 placebo-controlled trial could support NDA for oral teriparatide EB613 via 505(b)(2) pathway.","Primary endpoint: change in Total Hip BMD at 24 months in post-menopausal osteoporosis patients.","Planned 400 EB613 patients with 2:1 randomization; eligible patients BMD T-score ≤-2.5 to 3.0, no major fracture history.","Company to submit relative PK data comparing oral EB613 to subcutaneous Forteo.","Expects to initiate Phase 3 enrollment in 2023."],"urls":{"canonical":"https://secwatch.observer/filing/0001178913-22-003589","json":"https://secwatch.observer/filing/0001178913-22-003589.json","markdown":"https://secwatch.observer/filing/0001178913-22-003589.md","text":"https://secwatch.observer/filing/0001178913-22-003589.txt","edgar_index":"https://www.sec.gov/Archives/edgar/data/1638097/000117891322003589/0001178913-22-003589-index.htm","edgar_primary_document":"https://www.sec.gov/Archives/edgar/data/1638097/000117891322003589/form8k.htm"},"model":{"generated_by":"deepseek-v4-flash:cloud@v2","generated_at":"2026-06-23T05:04:00.598262+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"}