{"schema_version":"secwatch.filing_event.v1","accession":"0001193125-24-151965","form_type":"8-K","ticker":"MIRM","cik":"0001759425","company_name":"Mirum Pharmaceuticals, Inc.","filed_at":"2024-05-31T23:59:59+00:00","discovered_at":"2026-05-14T18:03:19.928043+00:00","generated_at":"2026-06-01T07:12:32.566089+00:00","sec_items":["8.01"],"event_type":"regulatory","sentiment":"positive","materiality_score":0.65,"calibrated_materiality_score":0.65,"confidence":"high","headline":"Mirum's LIVMARLI gets positive CHMP opinion for PFIC; EC decision in Q3 2024","bullets":["CHMP adopted positive opinion for LIVMARLI (maralixibat) to treat PFIC in patients aged 3 months and older.","CHMP concluded LIVMARLI provides significant clinical benefit vs already-approved PFIC treatment.","COMP recommended maintaining Orphan Drug Designation for LIVMARLI in PFIC.","European Commission decision on marketing authorization expected in Q3 2024."],"urls":{"canonical":"https://secwatch.observer/filing/0001193125-24-151965","json":"https://secwatch.observer/filing/0001193125-24-151965.json","markdown":"https://secwatch.observer/filing/0001193125-24-151965.md","text":"https://secwatch.observer/filing/0001193125-24-151965.txt","edgar_index":"https://www.sec.gov/Archives/edgar/data/1759425/000119312524151965/0001193125-24-151965-index.htm","edgar_primary_document":"https://www.sec.gov/Archives/edgar/data/1759425/000119312524151965/d825353d8k.htm"},"model":{"generated_by":"deepseek-v4-flash:cloud@v2","generated_at":"2026-06-01T07:12:32.566089+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"}