{"schema_version":"secwatch.filing_event.v1","accession":"0001104659-24-044928","form_type":"8-K","ticker":"BCLI","cik":"0001137883","company_name":"BRAINSTORM CELL THERAPEUTICS INC.","filed_at":"2024-04-09T23:59:59+00:00","discovered_at":"2026-05-14T18:03:17.424302+00:00","generated_at":"2026-06-04T00:43:13.761408+00:00","sec_items":["8.01","9.01"],"event_type":"regulatory","sentiment":"positive","materiality_score":0.7,"calibrated_materiality_score":0.7,"confidence":"high","headline":"BrainStorm announces FDA SPA agreement for Phase 3b trial of NurOwn in ALS","bullets":["FDA agreed on Phase 3b trial design under Special Protocol Assessment (SPA) for NurOwn in ALS.","Phase 3b trial (BCT-006-US) to enroll ~200 patients, double-blind placebo-controlled Part A (24 weeks) then open-label Part B.","Primary endpoint: change in ALSFRS-R total score at Week 24; CAFS to account for mortality.","Company expects trial commencement in 2024 after investigator and IRB approvals.","SPA validates protocol adequacy for supporting a future Biologics License Application (BLA)."],"urls":{"canonical":"https://secwatch.observer/filing/0001104659-24-044928","json":"https://secwatch.observer/filing/0001104659-24-044928.json","markdown":"https://secwatch.observer/filing/0001104659-24-044928.md","text":"https://secwatch.observer/filing/0001104659-24-044928.txt","edgar_index":"https://www.sec.gov/Archives/edgar/data/1137883/000110465924044928/0001104659-24-044928-index.htm","edgar_primary_document":"https://www.sec.gov/Archives/edgar/data/1137883/000110465924044928/tm2411382d1_8k.htm"},"model":{"generated_by":"deepseek-v4-flash:cloud@v2","generated_at":"2026-06-04T00:43:13.761408+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"}