{"schema_version":"secwatch.filing_event.v1","accession":"0001104659-22-101910","form_type":"8-K","ticker":"FENC","cik":"0001211583","company_name":"FENNEC PHARMACEUTICALS INC.","filed_at":"2022-09-21T23:59:59+00:00","discovered_at":"2026-05-14T18:03:55.156275+00:00","generated_at":"2026-06-23T08:13:48.849683+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 Pharma gets FDA approval for PEDMARK to reduce cisplatin-induced hearing loss in pediatric patients","bullets":["FDA approved PEDMARK (sodium thiosulfate) for reducing ototoxicity in children aged 1 month+ with localized, non-metastatic solid tumors.","PEDMARK is first and only FDA-approved therapy for this indication; based on two Phase 3 trials (SIOPEL6, COG ACCL0431).","Hearing loss incidence: 21.4% vs 73.3% (COG ACCL0431, p=0.005) and 32.7% vs 63% (SIOPEL6, p=0.002) with PEDMARK plus cisplatin vs cisplatin alone.","Common adverse reactions include vomiting, nausea, decreased hemoglobin, hypernatremia, hypokalemia; monitor electrolytes.","PEDMARK also holds FDA Orphan Drug designation; EU MAA for PEDMARQSI is under EMA evaluation."],"urls":{"canonical":"https://secwatch.observer/filing/0001104659-22-101910","json":"https://secwatch.observer/filing/0001104659-22-101910.json","markdown":"https://secwatch.observer/filing/0001104659-22-101910.md","text":"https://secwatch.observer/filing/0001104659-22-101910.txt","edgar_index":"https://www.sec.gov/Archives/edgar/data/1211583/000110465922101910/0001104659-22-101910-index.htm","edgar_primary_document":"https://www.sec.gov/Archives/edgar/data/1211583/000110465922101910/tm2226408d1_8k.htm"},"model":{"generated_by":"deepseek-v4-flash:cloud@v2","generated_at":"2026-06-23T08:13:48.849683+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"}