{"schema_version":"secwatch.filing_event.v1","accession":"0001171843-24-006545","form_type":"8-K","ticker":"FLNA","cik":"0001069530","company_name":"FILANA THERAPEUTICS, INC.","filed_at":"2024-11-25T23:59:59+00:00","discovered_at":"2026-05-14T18:03:07.569809+00:00","generated_at":"2026-05-29T18:35:47.901332+00:00","sec_items":["8.01","9.01"],"event_type":"other_material","sentiment":"negative","materiality_score":1.0,"calibrated_materiality_score":1.0,"confidence":"high","headline":"Cassava Sciences simufilam Phase 3 Alzheimer's trial misses all endpoints; studies halted","bullets":["Simufilam failed to meet co-primary endpoints: ADAS-COG12 delta -0.39 (p=0.43), ADCS-ADL delta 0.51 (p=0.40).","Company discontinues Phase 3 ReFocus-ALZ and open-label extension studies due to failed ReThink-ALZ results.","Simufilam showed favorable safety profile; serious AEs 13.0% vs 9.0% placebo; 1 death vs 3 in placebo.","Cash and equivalents approx $149M as of Q3 2024; company to evaluate next steps and present data at medical meeting.","Patient demographics balanced; mild-to-moderate AD enrollment; placebo decline less pronounced than expected."],"urls":{"canonical":"https://secwatch.observer/filing/0001171843-24-006545","json":"https://secwatch.observer/filing/0001171843-24-006545.json","markdown":"https://secwatch.observer/filing/0001171843-24-006545.md","text":"https://secwatch.observer/filing/0001171843-24-006545.txt","edgar_index":"https://www.sec.gov/Archives/edgar/data/1069530/000117184324006545/0001171843-24-006545-index.htm","edgar_primary_document":"https://www.sec.gov/Archives/edgar/data/1069530/000117184324006545/f8k_112524.htm"},"model":{"generated_by":"deepseek-v4-flash:cloud@v2","generated_at":"2026-05-29T18:35:47.901332+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"}