secwatch.observer — SEC 8-K summary
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Issuer:     Mirum Pharmaceuticals, Inc. (MIRM)
CIK:        0001759425
Form:       8-K
Filed at:   2024-06-17T23:59:59+00:00
Accession:  0001193125-24-162056
Event type: other_material
Sentiment:  positive
Materiality: 0.70
Item codes: 8.01
LLM model:  deepseek-v4-flash:cloud@v2

Mirum reports positive interim Ph2b data for volixibat in PBC and PSC
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- VANTAGE PBC trial: volixibat achieved placebo-adjusted -2.32 point itch reduction (p=0.0026); 75% of patients had >50% drop in serum bile acids.
- Significant fatigue improvement at week 16; no new safety signals; diarrhea (77%) mostly mild/moderate and transient; 4 SAEs (1 placebo).
- VANTAGE and VISTAS PSC trials to continue with volixibat 20 mg twice daily; independent data review committee recommended continuation for PSC.
- No clinically meaningful changes in liver biomarkers in PBC; sponsor remains blinded to interim results.

Source:
  EDGAR index:    https://www.sec.gov/Archives/edgar/data/1759425/000119312524162056/0001193125-24-162056-index.htm
  Primary doc:    https://www.sec.gov/Archives/edgar/data/1759425/000119312524162056/d853346d8k.htm
  HTML page:      https://secwatch.observer/filing/0001193125-24-162056

License: Source filings: public domain (SEC EDGAR). Summaries (headline + bullets): CC-BY-4.0; attribute https://secwatch.observer