secwatch.observer — SEC 8-K summary
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Issuer:     Mirum Pharmaceuticals, Inc. (MIRM)
CIK:        0001759425
Form:       8-K
Filed at:   2026-10-13T12:09:04+00:00
Accession:  0001759425-26-000051
Event type: other_material
Sentiment:  positive
Materiality: 0.75
Item codes: 8.01
LLM model:  deepseek-v4.1-flash:cloud@v2

Mirum LIVMARLI Phase 3 EXPAND meets primary endpoint; itch score -0.98 vs placebo, sNDA set for H1 2027
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- Phase 3 EXPAND enrolled 52 patients (46 pediatric, 6 adult); ItchRO(Obs) improved 1.81 points vs 0.83 for placebo, a 0.98-point difference (p=0.0004).
- All five prespecified secondary endpoints met, including three in biliary atresia with native liver: itch -2.16 vs -1.01 (p=0.0002) and sBA -75.5% vs -9.0% (p<0.0001).
- Serum bile acids fell 70.1% from baseline vs 3.5% for placebo in the overall population, a 69.0% treatment effect (p<0.0001).
- Safety consistent with prior maralixibat experience; diarrhea in 64.0% of treated vs 11.1% placebo patients, no deaths and no new safety signals.
- Mirum plans a U.S. supplemental New Drug Application in H1 2027; sees ~2,000 addressable BA patients in U.S./Europe.

Source:
  EDGAR index:    https://www.sec.gov/Archives/edgar/data/1759425/000175942526000051/0001759425-26-000051-index.htm
  Primary doc:    https://www.sec.gov/Archives/edgar/data/1759425/000175942526000051/mirm-20261012.htm
  HTML page:      https://secwatch.observer/filing/0001759425-26-000051

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