{"schema_version":"secwatch.filing_event.v1","accession":"0001104659-25-117697","form_type":"8-K","ticker":"FENC","cik":"0001211583","company_name":"FENNEC PHARMACEUTICALS INC.","filed_at":"2025-12-02T23:59:59+00:00","discovered_at":"2026-05-14T18:02:38.953073+00:00","generated_at":"2026-05-16T15:37:56.009751+00:00","sec_items":["8.01","9.01"],"event_type":"other_material","sentiment":"positive","materiality_score":0.7,"calibrated_materiality_score":0.7,"confidence":"high","headline":"Fennec PEDMARK Phase 2/3 Japan trial meets endpoint; hearing loss reduced to 16-24% vs 56-63% historical","bullets":["Primary endpoint met: hearing loss in 24% (ASHA) and 16% (Brock) of evaluable patients vs 56-63% historically.","Tumor response rate ~95%, showing PEDMARK does not interfere with cisplatin antitumor activity.","Company plans to pursue registration in Japan and explore partnering or licensing opportunities.","Study enrolled 27 patients aged 3-18 years in primary cohort; PEDMARK well-tolerated with no attributed adverse events."],"urls":{"canonical":"https://secwatch.observer/filing/0001104659-25-117697","json":"https://secwatch.observer/filing/0001104659-25-117697.json","markdown":"https://secwatch.observer/filing/0001104659-25-117697.md","text":"https://secwatch.observer/filing/0001104659-25-117697.txt","edgar_index":"https://www.sec.gov/Archives/edgar/data/1211583/000110465925117697/0001104659-25-117697-index.htm","edgar_primary_document":"https://www.sec.gov/Archives/edgar/data/1211583/000110465925117697/tm2532518d1_8k.htm"},"model":{"generated_by":"deepseek-v4-flash:cloud@v2","generated_at":"2026-05-16T15:37:56.009751+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"}