{"schema_version":"secwatch.filing_event.v1","accession":"0001437749-25-038313","form_type":"8-K","ticker":"FLNA","cik":"0001069530","company_name":"FILANA THERAPEUTICS, INC.","filed_at":"2025-12-18T23:59:59+00:00","discovered_at":"2026-05-14T18:02:38.713548+00:00","generated_at":"2026-05-16T12:42:00.148551+00:00","sec_items":["8.01"],"event_type":"regulatory","sentiment":"negative","materiality_score":0.75,"calibrated_materiality_score":0.75,"confidence":"high","headline":"FDA places Cassava's simufilam TSC-related epilepsy trial on full clinical hold; initiation delayed beyond H1 2026","bullets":["FDA letter on Dec 15, 2025 places proposed simufilam TSC-related epilepsy trial on full clinical hold.","Company must provide additional pre-clinical data and modify the protocol design to address FDA's items.","Initiation of proof-of-concept trial no longer expected in first half of 2026; revised timing depends on FDA review.","Cassava intends to work expeditiously to satisfy FDA's information requests but offers no new timeline."],"urls":{"canonical":"https://secwatch.observer/filing/0001437749-25-038313","json":"https://secwatch.observer/filing/0001437749-25-038313.json","markdown":"https://secwatch.observer/filing/0001437749-25-038313.md","text":"https://secwatch.observer/filing/0001437749-25-038313.txt","edgar_index":"https://www.sec.gov/Archives/edgar/data/1069530/000143774925038313/0001437749-25-038313-index.htm","edgar_primary_document":"https://www.sec.gov/Archives/edgar/data/1069530/000143774925038313/sava20251218_8k.htm"},"model":{"generated_by":"deepseek-v4-flash:cloud@v2","generated_at":"2026-05-16T12:42:00.148551+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"}