{"schema_version":"secwatch.filing_event.v1","accession":"0001171843-26-003931","form_type":"8-K","ticker":"EDSA","cik":"0001540159","company_name":"Edesa Biotech, Inc.","filed_at":"2026-06-05T13:25:18+00:00","discovered_at":"2026-06-05T13:26:00.309801+00:00","generated_at":"2026-06-05T13:26:10.605509+00:00","sec_items":["8.01"],"event_type":"other_material","sentiment":"positive","materiality_score":0.75,"calibrated_materiality_score":0.75,"confidence":"high","headline":"Edesa Biotech: paridiprubart shows 32% relative mortality reduction in AKI/ARDS patients","bullets":["Exploratory Phase 3 data: paridiprubart + SOC reduced 28-day mortality to 33% vs 49% placebo (p<0.005).","MAKE30 composite endpoint incidence reduced to 41% from 53% (23% relative reduction, p<0.005).","AKI cohort of 101 severely ill patients (90% moderate-to-severe ARDS, ~50% on ventilation/ECMO).","Paridiprubart well tolerated; no significant differences in adverse events vs placebo.","Data presented at ERA Congress 2026; results exploratory and require confirmatory studies."],"urls":{"canonical":"https://secwatch.observer/filing/0001171843-26-003931","json":"https://secwatch.observer/filing/0001171843-26-003931.json","markdown":"https://secwatch.observer/filing/0001171843-26-003931.md","text":"https://secwatch.observer/filing/0001171843-26-003931.txt","edgar_index":"https://www.sec.gov/Archives/edgar/data/1540159/000117184326003931/0001171843-26-003931-index.htm","edgar_primary_document":"https://www.sec.gov/Archives/edgar/data/1540159/000117184326003931/f8k_060226.htm"},"model":{"generated_by":"deepseek-v4-flash:cloud@v2","generated_at":"2026-06-05T13:26:10.605509+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"}