---
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"
generated_at: "2026-06-01T07:12:32.566089+00:00"
event_type: "regulatory"
sentiment: "positive"
materiality_score: 0.65
calibrated_materiality_score: 0.65
confidence: "high"
source: SEC EDGAR
---

# Mirum's LIVMARLI gets positive CHMP opinion for PFIC; EC decision in Q3 2024

## Summary
- 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.

## SEC filing metadata
- 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
- event_type: regulatory
- sentiment: positive
- materiality_score: 0.65
- calibrated_materiality_score: 0.65
- confidence: high
- sec_items: 8.01
- 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

## Machine-readable alternates
- HTML: https://secwatch.observer/filing/0001193125-24-151965
- JSON: https://secwatch.observer/filing/0001193125-24-151965.json
- Plain text: https://secwatch.observer/filing/0001193125-24-151965.txt

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