{"schema_version":"secwatch.filing_event.v1","accession":"0001104659-23-041338","form_type":"8-K","ticker":"FENC","cik":"0001211583","company_name":"FENNEC PHARMACEUTICALS INC.","filed_at":"2023-04-04T23:59:59+00:00","discovered_at":"2026-05-14T18:03:38.175131+00:00","generated_at":"2026-06-17T06:19:41.500865+00:00","sec_items":["8.01","9.01"],"event_type":"regulatory","sentiment":"positive","materiality_score":0.85,"calibrated_materiality_score":0.85,"confidence":"high","headline":"Fennec receives positive CHMP opinion for Pedmarqsi to prevent cisplatin-induced hearing loss in pediatric patients","bullets":["CHMP recommends EU marketing authorization for Pedmarqsi (sodium thiosulfate) to prevent ototoxicity in pediatric patients aged 1 month to <18 years with localized solid tumors.","Phase 3 trial SIOPEL 6 showed hearing loss in 28.6% with Pedmarqsi vs 56.4% with cisplatin alone (p=0.004).","European Commission decision expected by early June 2023; Pedmarqsi is already FDA-approved as PEDMARK in the U.S.","Approximately 5,000 children in Europe annually eligible for platinum-based chemotherapy could benefit from this therapy."],"urls":{"canonical":"https://secwatch.observer/filing/0001104659-23-041338","json":"https://secwatch.observer/filing/0001104659-23-041338.json","markdown":"https://secwatch.observer/filing/0001104659-23-041338.md","text":"https://secwatch.observer/filing/0001104659-23-041338.txt","edgar_index":"https://www.sec.gov/Archives/edgar/data/1211583/000110465923041338/0001104659-23-041338-index.htm","edgar_primary_document":"https://www.sec.gov/Archives/edgar/data/1211583/000110465923041338/tm2311156d1_8k.htm"},"model":{"generated_by":"deepseek-v4-flash:cloud@v2","generated_at":"2026-06-17T06:19:41.500865+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"}