{"schema_version":"secwatch.filing_event.v1","accession":"0001104659-26-108565","form_type":"8-K","ticker":"FENC","cik":"0001211583","company_name":"FENNEC PHARMACEUTICALS INC.","filed_at":"2026-09-17T20:03:17+00:00","discovered_at":"2026-09-17T20:04:02.216635+00:00","generated_at":"2026-09-17T20:04:06.874309+00:00","sec_items":["8.01","9.01"],"event_type":"other_material","sentiment":"positive","materiality_score":0.85,"calibrated_materiality_score":0.85,"confidence":"high","headline":"Fennec's PEDMARK hits primary endpoint in Japan Phase 2, 24% hearing loss vs 56.4%","bullets":["Phase 2 STS-J01 met primary endpoint: ASHA-defined hearing loss 24.0% (6/25) vs 56.4% historical benchmark (P=0.001).","No Grade 3/4 hearing loss by Brock criteria; 84.0% Grade 0 hearing loss.","Objective tumor responses in 23/24 evaluable patients (95.8%), no interference with cisplatin antitumor activity.","Company pursuing Japanese registration and exploring partnering/licensing for PEDMARK.","Safety consistent with known profile; no serious adverse events attributed to PEDMARK."],"urls":{"canonical":"https://secwatch.observer/filing/0001104659-26-108565","json":"https://secwatch.observer/filing/0001104659-26-108565.json","markdown":"https://secwatch.observer/filing/0001104659-26-108565.md","text":"https://secwatch.observer/filing/0001104659-26-108565.txt","edgar_index":"https://www.sec.gov/Archives/edgar/data/1211583/000110465926108565/0001104659-26-108565-index.htm","edgar_primary_document":"https://www.sec.gov/Archives/edgar/data/1211583/000110465926108565/fencf-20260917x8k.htm"},"model":{"generated_by":"deepseek-v4-flash:cloud@v2","generated_at":"2026-09-17T20:04:06.874309+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"}