secwatch.observer — SEC 8-K summary
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Issuer:     Mirum Pharmaceuticals, Inc. (MIRM)
CIK:        0001759425
Form:       8-K
Filed at:   2022-12-13T23:59:59+00:00
Accession:  0001193125-22-303831
Event type: regulatory
Sentiment:  positive
Materiality: 0.85
Item codes: 8.01
LLM model:  deepseek-v4-flash:cloud@v2

Mirum receives EC approval for LIVMARLI in Alagille syndrome across EU
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- European Commission granted marketing authorization for LIVMARLI (maralixibat) oral solution.
- Indicated for cholestatic pruritus in Alagille syndrome patients aged 2 months and older.
- First and only approved treatment for ALGS in both EU and US; ALGS affects 1 in 30,000 globally.
- Approval follows positive CHMP opinion from September 2022.
- Authorization covers all 27 EU member states for marketing.

Source:
  EDGAR index:    https://www.sec.gov/Archives/edgar/data/1759425/000119312522303831/0001193125-22-303831-index.htm
  Primary doc:    https://www.sec.gov/Archives/edgar/data/1759425/000119312522303831/d384957d8k.htm
  HTML page:      https://secwatch.observer/filing/0001193125-22-303831

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