---
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"
generated_at: "2026-05-14T23:57:23.830368+00:00"
event_type: "other_material"
sentiment: "positive"
materiality_score: 0.85
calibrated_materiality_score: 0.85
confidence: "high"
source: SEC EDGAR
---

# Mirum's volixibat meets primary endpoint in PSC Phase 2b VISTAS study with statistically significant itch reduction

## Summary
- 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.

## SEC filing metadata
- 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
- event_type: other_material
- sentiment: positive
- materiality_score: 0.85
- calibrated_materiality_score: 0.85
- confidence: high
- sec_items: 8.01
- 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

## Machine-readable alternates
- HTML: https://secwatch.observer/filing/0001193125-26-202609
- JSON: https://secwatch.observer/filing/0001193125-26-202609.json
- Plain text: https://secwatch.observer/filing/0001193125-26-202609.txt

This AI-assisted summary is a reading aid. Review the linked SEC EDGAR filing before relying on any specific claim.