{"schema_version":"secwatch.filing_event.v1","accession":"0001178913-22-003937","form_type":"8-K","ticker":"ENTXW","cik":"0001638097","company_name":"Entera Bio Ltd.","filed_at":"2022-11-10T23:59:59+00:00","discovered_at":"2026-05-14T18:03:51.525647+00:00","generated_at":"2026-06-21T23:04:41.346982+00:00","sec_items":["2.02","7.01","9.01"],"event_type":"regulatory","sentiment":"positive","materiality_score":0.9,"calibrated_materiality_score":0.9,"confidence":"high","headline":"Entera Bio announces FDA agreement for single pivotal Phase 3 study of oral PTH tablet EB613 with BMD endpoint","bullets":["FDA agreed that a single placebo-controlled Phase 3 study with total hip BMD as primary endpoint can support NDA for EB613.","EB613 is the first daily oral tablet formulation of teriparatide (Forteo), targeting post-menopausal osteoporosis.","Patient enrollment in the pivotal Phase 3 study is expected to commence in 2023.","Q3 2022 net loss $3.1M ($0.11 per share); cash $14.3M, expected to fund operations through Q2 2023.","Revenue was $8K (down from $140K) primarily due to finalization of Amgen pre-clinical services."],"urls":{"canonical":"https://secwatch.observer/filing/0001178913-22-003937","json":"https://secwatch.observer/filing/0001178913-22-003937.json","markdown":"https://secwatch.observer/filing/0001178913-22-003937.md","text":"https://secwatch.observer/filing/0001178913-22-003937.txt","edgar_index":"https://www.sec.gov/Archives/edgar/data/1638097/000117891322003937/0001178913-22-003937-index.htm","edgar_primary_document":"https://www.sec.gov/Archives/edgar/data/1638097/000117891322003937/form8k.htm"},"model":{"generated_by":"deepseek-v4-flash:cloud@v2","generated_at":"2026-06-21T23:04:41.346982+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":[{"claim_id":"52bca70dc39c73cfbfd28cb44ebd5a0d3ee30866","claim":"Entera Bio Ltd. reported financial results for the third quarter of 2022.","evidence_excerpt":"Entera Bio Ltd., a company organized under the laws of the State of Israel (“we,” “us,”, “our” or the “Company”), issued a press release announcing its financial results for the three and nine months ended September 30, 2022.","evidence_source":"SEC 8-K Item 2.02","evidence_url":"https://www.sec.gov/Archives/edgar/data/1638097/000117891322003937/0001178913-22-003937-index.htm","confidence":0.9,"family_label":"Earnings Releases","details":[{"label":"Period","value":"the third quarter of 2022"},{"label":"Result","value":"reported results"}],"fact_type":"earnings_release"}],"license":"Source filings: public domain (SEC EDGAR). Summaries (headline + bullets): CC-BY-4.0; attribute https://secwatch.observer"}