{"schema_version":"secwatch.filing_event.v1","accession":"0001104659-23-008450","form_type":"8-K","ticker":"FENC","cik":"0001211583","company_name":"FENNEC PHARMACEUTICALS INC.","filed_at":"2023-01-31T23:59:59+00:00","discovered_at":"2026-05-14T18:03:44.089473+00:00","generated_at":"2026-06-20T05:01:46.641841+00:00","sec_items":["8.01","9.01"],"event_type":"regulatory","sentiment":"positive","materiality_score":0.75,"calibrated_materiality_score":0.75,"confidence":"high","headline":"Fennec receives FDA Orphan Drug Exclusivity for PEDMARK; 7-year market exclusivity until 2029","bullets":["FDA granted Orphan Drug Exclusivity to PEDMARK, providing 7-year market exclusivity from Sept. 20, 2022 to Sept. 20, 2029.","PEDMARK is the first and only FDA-approved therapy to reduce cisplatin-induced ototoxicity in pediatric solid tumor patients.","Company holds three Orange Book patents for PEDMARK, with protection until 2038-2039.","FDA explicitly directed that PEDMARK is not substitutable with other sodium thiosulfate products."],"urls":{"canonical":"https://secwatch.observer/filing/0001104659-23-008450","json":"https://secwatch.observer/filing/0001104659-23-008450.json","markdown":"https://secwatch.observer/filing/0001104659-23-008450.md","text":"https://secwatch.observer/filing/0001104659-23-008450.txt","edgar_index":"https://www.sec.gov/Archives/edgar/data/1211583/000110465923008450/0001104659-23-008450-index.htm","edgar_primary_document":"https://www.sec.gov/Archives/edgar/data/1211583/000110465923008450/tm235024d1_8k.htm"},"model":{"generated_by":"deepseek-v4-flash:cloud@v2","generated_at":"2026-06-20T05:01:46.641841+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"}