{"schema_version":"secwatch.filing_event.v1","accession":"0000950170-22-011935","form_type":"8-K","ticker":"LONA","cik":"0001620463","company_name":"LeonaBio, Inc.","filed_at":"2022-06-22T23:59:59+00:00","discovered_at":"2026-05-14T18:04:01.515627+00:00","generated_at":"2026-06-25T00:00:03.242689+00:00","sec_items":["8.01","7.01","9.01"],"event_type":"other_material","sentiment":"negative","materiality_score":0.8,"calibrated_materiality_score":0.8,"confidence":"high","headline":"Athira Phase 2 ACT-AD misses primary endpoint; monotherapy subgroup shows cognitive benefit","bullets":["Primary endpoint ERP P300 latency not statistically significant in full mITT population (-6.02 ms vs placebo).","Pre-specified subgroup: combination with AChEIs diminished fosgonimeton effect; post hoc monotherapy showed ERP P300 improvement of -28 ms and ADAS-Cog11 -3.3 points.","Fosgonimeton well tolerated; no treatment-related SAEs or deaths; injection site reaction most common AE.","Study enrolled 77 patients; 14% early termination rate; results to inform ongoing Phase 3 LIFT-AD (NCT04488419).","Management plans to seek regulatory advice on potential adaptations to LIFT-AD based on these findings."],"urls":{"canonical":"https://secwatch.observer/filing/0000950170-22-011935","json":"https://secwatch.observer/filing/0000950170-22-011935.json","markdown":"https://secwatch.observer/filing/0000950170-22-011935.md","text":"https://secwatch.observer/filing/0000950170-22-011935.txt","edgar_index":"https://www.sec.gov/Archives/edgar/data/1620463/000095017022011935/0000950170-22-011935-index.htm","edgar_primary_document":"https://www.sec.gov/Archives/edgar/data/1620463/000095017022011935/atha-20220622.htm"},"model":{"generated_by":"deepseek-v4-flash:cloud@v2","generated_at":"2026-06-25T00:00:03.242689+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"}