{"schema_version":"secwatch.filing_event.v1","accession":"0000950170-24-102788","form_type":"8-K","ticker":"LONA","cik":"0001620463","company_name":"LeonaBio, Inc.","filed_at":"2024-09-03T23:59:59+00:00","discovered_at":"2026-05-14T18:03:13.831629+00:00","generated_at":"2026-05-31T06:37:58.620171+00:00","sec_items":["8.01","7.01","9.01"],"event_type":"other_material","sentiment":"negative","materiality_score":0.9,"calibrated_materiality_score":0.9,"confidence":"high","headline":"Athira's Phase 2/3 LIFT-AD trial of fosgonimeton misses primary endpoint; biomarker data mixed","bullets":["Primary endpoint GST (p=0.70) and key secondary endpoints ADAS-Cog11 (p=0.35) and ADCS-ADL23 (p=0.61) not met; directionally favored fosgonimeton.","Prespecified subgroups (moderate AD, APOE4 carriers) showed numerically greater treatment effects; e.g., moderate AD ADAS-Cog11 delta -1.16 (p=0.39).","Biomarker p-Tau217 significantly reduced (p<0.01); NfL, GFAP, Aβ42/40 improved directionally.","Preliminary cash resources ~$75.1M as of Aug 31, 2024; ATH-1105 Phase 1 ongoing, completion expected by year-end 2024, ALS patients targeted for 2025.","Fosgonimeton well tolerated; SAEs similar to placebo; 22% early termination rate; full results to be presented at CTAD Oct 29-Nov 1, 2024."],"urls":{"canonical":"https://secwatch.observer/filing/0000950170-24-102788","json":"https://secwatch.observer/filing/0000950170-24-102788.json","markdown":"https://secwatch.observer/filing/0000950170-24-102788.md","text":"https://secwatch.observer/filing/0000950170-24-102788.txt","edgar_index":"https://www.sec.gov/Archives/edgar/data/1620463/000095017024102788/0000950170-24-102788-index.htm","edgar_primary_document":"https://www.sec.gov/Archives/edgar/data/1620463/000095017024102788/atha-20240903.htm"},"model":{"generated_by":"deepseek-v4-flash:cloud@v2","generated_at":"2026-05-31T06:37:58.620171+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"}