{"schema_version":"secwatch.filing_event.v1","accession":"0001171843-25-006690","form_type":"8-K","ticker":"EDSA","cik":"0001540159","company_name":"Edesa Biotech, Inc.","filed_at":"2025-10-28T23:59:59+00:00","discovered_at":"2026-05-14T18:02:39.690213+00:00","generated_at":"2026-05-17T01:55:39.536979+00:00","sec_items":["8.01"],"event_type":"other_material","sentiment":"positive","materiality_score":0.85,"calibrated_materiality_score":0.85,"confidence":"high","headline":"Edesa Biotech reports positive Phase 3 results for paridiprubart in ARDS; 28-day mortality reduced 13% absolute","bullets":["Paridiprubart + SOC reduced 28-day mortality to 39% vs 52% placebo (n=104; p<0.001): 13% absolute improvement, 25% relative risk reduction.","Durable survival benefit at 60 days: 46% vs 59% mortality (p=0.003); 13% absolute improvement, 22% relative risk reduction.","Paridiprubart arm showed 41% higher relative rate of clinical improvement (≥2-point WCSS improvement at Day 28; p=0.032).","Safety data from >275 subjects: paridiprubart generally well-tolerated, consistent with prior profile.","Paridiprubart also in U.S. government 'Just Breathe' study; program funded by Government of Canada's Strategic Innovation Fund."],"urls":{"canonical":"https://secwatch.observer/filing/0001171843-25-006690","json":"https://secwatch.observer/filing/0001171843-25-006690.json","markdown":"https://secwatch.observer/filing/0001171843-25-006690.md","text":"https://secwatch.observer/filing/0001171843-25-006690.txt","edgar_index":"https://www.sec.gov/Archives/edgar/data/1540159/000117184325006690/0001171843-25-006690-index.htm","edgar_primary_document":"https://www.sec.gov/Archives/edgar/data/1540159/000117184325006690/f8k_102825.htm"},"model":{"generated_by":"deepseek-v4-flash:cloud@v2","generated_at":"2026-05-17T01:55:39.536979+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"}