{"schema_version":"secwatch.filing_event.v1","accession":"0001759425-26-000051","form_type":"8-K","ticker":"MIRM","cik":"0001759425","company_name":"Mirum Pharmaceuticals, Inc.","filed_at":"2026-10-13T12:09:04+00:00","discovered_at":"2026-10-13T12:10:00.316963+00:00","generated_at":"2026-10-13T12:10:06.988985+00:00","sec_items":["8.01"],"event_type":"other_material","sentiment":"positive","materiality_score":0.75,"calibrated_materiality_score":0.75,"confidence":"high","headline":"Mirum LIVMARLI Phase 3 EXPAND meets primary endpoint; itch score -0.98 vs placebo, sNDA set for H1 2027","bullets":["Phase 3 EXPAND enrolled 52 patients (46 pediatric, 6 adult); ItchRO(Obs) improved 1.81 points vs 0.83 for placebo, a 0.98-point difference (p=0.0004).","All five prespecified secondary endpoints met, including three in biliary atresia with native liver: itch -2.16 vs -1.01 (p=0.0002) and sBA -75.5% vs -9.0% (p<0.0001).","Serum bile acids fell 70.1% from baseline vs 3.5% for placebo in the overall population, a 69.0% treatment effect (p<0.0001).","Safety consistent with prior maralixibat experience; diarrhea in 64.0% of treated vs 11.1% placebo patients, no deaths and no new safety signals.","Mirum plans a U.S. supplemental New Drug Application in H1 2027; sees ~2,000 addressable BA patients in U.S./Europe."],"urls":{"canonical":"https://secwatch.observer/filing/0001759425-26-000051","json":"https://secwatch.observer/filing/0001759425-26-000051.json","markdown":"https://secwatch.observer/filing/0001759425-26-000051.md","text":"https://secwatch.observer/filing/0001759425-26-000051.txt","edgar_index":"https://www.sec.gov/Archives/edgar/data/1759425/000175942526000051/0001759425-26-000051-index.htm","edgar_primary_document":"https://www.sec.gov/Archives/edgar/data/1759425/000175942526000051/mirm-20261012.htm"},"model":{"generated_by":"deepseek-v4.1-flash:cloud@v2","generated_at":"2026-10-13T12:10:06.988985+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"}