{"schema_version":"secwatch.filing_event.v1","accession":"0001178913-26-000714","form_type":"8-K","ticker":"ENTXW","cik":"0001638097","company_name":"Entera Bio Ltd.","filed_at":"2026-03-04T23:59:59+00:00","discovered_at":"2026-05-14T18:02:35.714558+00:00","generated_at":"2026-05-15T21:41:33.015365+00:00","sec_items":["7.01","9.01"],"event_type":"regulatory","sentiment":"positive","materiality_score":0.9,"calibrated_materiality_score":0.9,"confidence":"high","headline":"Entera Bio submits streamlined Phase 3 protocol for EB613 to FDA; topline data H2 2028","bullets":["Phase 3 trial to enroll 750 postmenopausal women with osteoporosis; primary endpoint total hip BMD at 12 months.","Single tablet final commercial formulation (Next-Gen EB613) replaces multi-tablet candidate; no bridging needed.","FDA feedback expected within 60 days; topline results anticipated in second half of 2028, one year earlier than prior guidance.","12-month open-label extension study submitted; will run in parallel with potential NDA review."],"urls":{"canonical":"https://secwatch.observer/filing/0001178913-26-000714","json":"https://secwatch.observer/filing/0001178913-26-000714.json","markdown":"https://secwatch.observer/filing/0001178913-26-000714.md","text":"https://secwatch.observer/filing/0001178913-26-000714.txt","edgar_index":"https://www.sec.gov/Archives/edgar/data/1638097/000117891326000714/0001178913-26-000714-index.htm","edgar_primary_document":"https://www.sec.gov/Archives/edgar/data/1638097/000117891326000714/zk2634484.htm"},"model":{"generated_by":"deepseek-v4-flash:cloud@v2","generated_at":"2026-05-15T21:41:33.015365+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"}