{"schema_version":"secwatch.filing_event.v1","accession":"0001759425-26-000049","form_type":"8-K","ticker":"MIRM","cik":"0001759425","company_name":"Mirum Pharmaceuticals, Inc.","filed_at":"2026-09-28T12:02:47+00:00","discovered_at":"2026-09-28T12:05:01.553571+00:00","generated_at":"2026-10-12T13:30:54.204088+00:00","sec_items":["8.01"],"event_type":"regulatory","sentiment":"positive","materiality_score":0.9,"calibrated_materiality_score":0.9,"confidence":"high","headline":"FDA approves Mirum/Incyte's Atebrioz for FOP; brelovitug meets AZURE-1 Phase 3 primary endpoint","bullets":["FDA approved Atebrioz (zilurgisertib) 100 mg once daily to reduce total new heterotopic ossification volume in FOP patients aged 12+; U.S. launch expected October 2026.","In PROGRESS Cohort 1, Week 24 mean new HO lesion volume fell 3.2 cm3 with zilurgisertib vs increase of 24.6 cm3 on placebo; effects maintained through Week 48.","Phase 3 AZURE-1: brelovitug met primary endpoint with 56% (300 mg QW) and 45% (900 mg Q4W) vs 0% delayed treatment (p<0.0001) in 153 treatment-naive chronic HDV patients.","Brelovitug BLA submission expected H1 2027 and U.S. launch Q4 2027; AZURE-4 topline due Q4 2026. Mirum estimates >$1B annual revenue potential for brelovitug and >$200M for Atebrioz.","Week 48 Phase 2b data showed deepening response: 300 mg QW primary endpoint rate rose from 45% to 55%, 900 mg Q4W from 35% to 55%; no new safety signals."],"urls":{"canonical":"https://secwatch.observer/filing/0001759425-26-000049","json":"https://secwatch.observer/filing/0001759425-26-000049.json","markdown":"https://secwatch.observer/filing/0001759425-26-000049.md","text":"https://secwatch.observer/filing/0001759425-26-000049.txt","edgar_index":"https://www.sec.gov/Archives/edgar/data/1759425/000175942526000049/0001759425-26-000049-index.htm","edgar_primary_document":"https://www.sec.gov/Archives/edgar/data/1759425/000175942526000049/mirm-20260925.htm"},"model":{"generated_by":"deepseek-v4.1-flash:cloud@v2","generated_at":"2026-10-12T13:30:54.204088+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"}