{"schema_version":"secwatch.filing_event.v1","accession":"0001193125-26-202609","form_type":"8-K","ticker":"MIRM","cik":"0001759425","company_name":"Mirum Pharmaceuticals, Inc.","filed_at":"2026-05-04T23:59:59+00:00","discovered_at":"2026-05-14T18:02:32.865844+00:00","generated_at":"2026-05-14T23:57:23.830368+00:00","sec_items":["8.01"],"event_type":"other_material","sentiment":"positive","materiality_score":0.85,"calibrated_materiality_score":0.85,"confidence":"high","headline":"Mirum's volixibat meets primary endpoint in PSC Phase 2b VISTAS study with statistically significant itch reduction","bullets":["Volixibat showed 2.72 point improvement in pruritus vs 1.08 for placebo; placebo-adjusted difference 1.64 (p<0.0001).","55.6% of volixibat patients achieved ≥2 point reduction in Adult ItchRO vs 26.3% for placebo (p=0.0019).","Pre-NDA meeting with FDA scheduled summer 2026; NDA submission planned H2 2026.","VANTAGE Phase 2b study in PBC top-line data now expected Q1 2027.","Most common adverse event was diarrhea (40.3% volixibat vs 8.6% placebo); SAEs in volixibat group not considered related."],"urls":{"canonical":"https://secwatch.observer/filing/0001193125-26-202609","json":"https://secwatch.observer/filing/0001193125-26-202609.json","markdown":"https://secwatch.observer/filing/0001193125-26-202609.md","text":"https://secwatch.observer/filing/0001193125-26-202609.txt","edgar_index":"https://www.sec.gov/Archives/edgar/data/1759425/000119312526202609/0001193125-26-202609-index.htm","edgar_primary_document":"https://www.sec.gov/Archives/edgar/data/1759425/000119312526202609/d150234d8k.htm"},"model":{"generated_by":"deepseek-v4-flash:cloud@v2","generated_at":"2026-05-14T23:57:23.830368+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"}