{"schema_version":"secwatch.filing_event.v1","accession":"0001650664-26-000093","form_type":"8-K","ticker":"EDIT","cik":"0001650664","company_name":"Editas Medicine, Inc.","filed_at":"2026-10-08T11:04:33+00:00","discovered_at":"2026-10-08T11:05:01.275993+00:00","generated_at":"2026-10-12T15:39:19.320972+00:00","sec_items":["7.01","8.01","9.01"],"event_type":"regulatory","sentiment":"positive","materiality_score":0.65,"calibrated_materiality_score":0.65,"confidence":"high","headline":"Editas receives Australian approval to initiate Phase 1/2 Strive trial of EDIT-401 in HeFH","bullets":["Australia's TGA and HREC cleared the Phase 1/2 Strive trial of EDIT-401; a submission is also under review in New Zealand, with five trial sites selected across both countries.","Strive is two-part: Part 1 single ascending dose, open-label; Part 2 single-dose, randomized, placebo-controlled. Initial safety/tolerability data expected Q1 2027. Topline later in 2027.","Preclinical data showed ~90% or greater mean reduction in LDL-C, Lp(a) and ApoB in non-human primates; ~90% LDL-C reduction was maintained over 10 months.","Editas will present EDIT-401 durability data at AHA Scientific Sessions on Nov 8, 2026, in Chicago; CMO Dan Ory, M.D. is the presenter.","Editas remains on track to begin patient dosing in 2026 and plans to complete Part 1 enrollment with topline safety and efficacy results later in 2027."],"urls":{"canonical":"https://secwatch.observer/filing/0001650664-26-000093","json":"https://secwatch.observer/filing/0001650664-26-000093.json","markdown":"https://secwatch.observer/filing/0001650664-26-000093.md","text":"https://secwatch.observer/filing/0001650664-26-000093.txt","edgar_index":"https://www.sec.gov/Archives/edgar/data/1650664/000165066426000093/0001650664-26-000093-index.htm","edgar_primary_document":"https://www.sec.gov/Archives/edgar/data/1650664/000165066426000093/edit-20261008.htm"},"model":{"generated_by":"deepseek-v4.1-flash:cloud@v2","generated_at":"2026-10-12T15:39:19.320972+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"}