{"schema_version":"secwatch.filing_event.v1","accession":"0001178913-25-002484","form_type":"8-K","ticker":"ENTXW","cik":"0001638097","company_name":"Entera Bio Ltd.","filed_at":"2025-07-28T23:59:59+00:00","discovered_at":"2026-05-14T18:02:44.538879+00:00","generated_at":"2026-05-18T00:17:54.942375+00:00","sec_items":["7.01","8.01","9.01"],"event_type":"regulatory","sentiment":"positive","materiality_score":0.8,"calibrated_materiality_score":0.8,"confidence":"high","headline":"Entera Bio wins FDA agreement to use BMD as primary endpoint for EB613 Phase 3 osteoporosis study","bullets":["FDA agreed single 24-month, placebo-controlled Phase 3 study with total hip BMD as primary endpoint; fracture incidence as key secondary.","Shift from traditional fracture-endpoint trials; no dedicated oral carcinogenicity or DART studies required by FDA.","Phase 3 study targets postmenopausal women; EB613 is first oral anabolic tablet for osteoporosis.","FDA's SABRE qualification still expected later this year but not needed to proceed.","CEO Miranda Toledano calls it a major milestone; no new osteoporosis drug approved by FDA since 2019."],"urls":{"canonical":"https://secwatch.observer/filing/0001178913-25-002484","json":"https://secwatch.observer/filing/0001178913-25-002484.json","markdown":"https://secwatch.observer/filing/0001178913-25-002484.md","text":"https://secwatch.observer/filing/0001178913-25-002484.txt","edgar_index":"https://www.sec.gov/Archives/edgar/data/1638097/000117891325002484/0001178913-25-002484-index.htm","edgar_primary_document":"https://www.sec.gov/Archives/edgar/data/1638097/000117891325002484/zk2533483.htm"},"model":{"generated_by":"deepseek-v4-flash:cloud@v2","generated_at":"2026-05-18T00:17:54.942375+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"}