secwatch.observer — SEC 8-K summary
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Issuer:     Mirum Pharmaceuticals, Inc. (MIRM)
CIK:        0001759425
Form:       8-K
Filed at:   2026-04-27T23:59:59+00:00
Accession:  0001193125-26-179048
Event type: other_material
Sentiment:  positive
Materiality: 0.80
Item codes: 8.01
LLM model:  deepseek-v4-flash:cloud@v2

Mirum's brelovitug meets Phase 2b primary endpoint in chronic HDV; 100% virologic response at 300 mg QW
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- 100% of patients on 300 mg QW and 75% on 900 mg Q4W achieved virologic response vs 0% control.
- Primary composite endpoint (virologic response + ALT normalization) reached by 45% and 35% vs 0% control (p=0.003, 0.024).
- Brelovitug was well tolerated; no discontinuations, low grade 3+ events, no related serious AEs.
- Full Phase 2b results to be presented at EASL Congress May 27-30, 2026.
- Phase 3 topline data from AZURE-1/4 expected H2 2026; potential U.S. BLA submission in 2027.

Source:
  EDGAR index:    https://www.sec.gov/Archives/edgar/data/1759425/000119312526179048/0001193125-26-179048-index.htm
  Primary doc:    https://www.sec.gov/Archives/edgar/data/1759425/000119312526179048/d116875d8k.htm
  HTML page:      https://secwatch.observer/filing/0001193125-26-179048

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