secwatch.observer — SEC 8-K summary
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Issuer:     Mirum Pharmaceuticals, Inc. (MIRM)
CIK:        0001759425
Form:       8-K
Filed at:   2026-05-04T23:59:59+00:00
Accession:  0001193125-26-202609
Event type: other_material
Sentiment:  positive
Materiality: 0.85
Item codes: 8.01
LLM model:  deepseek-v4-flash:cloud@v2

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

Source:
  EDGAR index:    https://www.sec.gov/Archives/edgar/data/1759425/000119312526202609/0001193125-26-202609-index.htm
  Primary doc:    https://www.sec.gov/Archives/edgar/data/1759425/000119312526202609/d150234d8k.htm
  HTML page:      https://secwatch.observer/filing/0001193125-26-202609

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