{"schema_version":"secwatch.filing_event.v1","accession":"0001171843-26-006161","form_type":"8-K","ticker":"FLNA","cik":"0001069530","company_name":"FILANA THERAPEUTICS, INC.","filed_at":"2026-09-22T12:00:40+00:00","discovered_at":"2026-09-22T12:05:19.345952+00:00","generated_at":"2026-09-22T12:05:38.522350+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":"FDA lifts clinical hold on Filana's simufilam, enabling Phase 2a trial for TSC-related epilepsy","bullets":["FDA lifted full clinical hold on Filana's IND for simufilam on Sept 22, 2026, enabling Phase 2a trial in TSC-related epilepsy.","Phase 2a trial: 16-week, randomized, double-blind, two doses, 13 U.S. sites, target 40 subjects aged 12-55; screening expected Q1 2027.","Company completed trial-readiness during hold: engaged leading CRO, identified sites, recruiting investigators, drug supply in place.","TSC Alliance CEO Kari Luther Rosbeck praised work; simufilam reduced seizure frequency in two preclinical mouse models."],"urls":{"canonical":"https://secwatch.observer/filing/0001171843-26-006161","json":"https://secwatch.observer/filing/0001171843-26-006161.json","markdown":"https://secwatch.observer/filing/0001171843-26-006161.md","text":"https://secwatch.observer/filing/0001171843-26-006161.txt","edgar_index":"https://www.sec.gov/Archives/edgar/data/1069530/000117184326006161/0001171843-26-006161-index.htm","edgar_primary_document":"https://www.sec.gov/Archives/edgar/data/1069530/000117184326006161/f8k_092226.htm"},"model":{"generated_by":"deepseek-v4-flash:cloud@v2","generated_at":"2026-09-22T12:05:38.522350+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"}