secwatch.observer — SEC 8-K summary
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Issuer:     Mirum Pharmaceuticals, Inc. (MIRM)
CIK:        0001759425
Form:       8-K
Filed at:   2023-10-17T23:59:59+00:00
Accession:  0001193125-23-257711
Event type: regulatory
Sentiment:  negative
Materiality: 0.60
Item codes: 8.01
LLM model:  deepseek-v4-flash:cloud@v2

FDA extends review of Mirum's LIVMARLI sNDA for PFIC; new PDUFA date March 13, 2024
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- FDA extended PDUFA goal date to March 13, 2024, from original October 2023 target.
- Extension due to FDA deeming Company's response to information request a major amendment.
- Submission included further analysis of previously provided clinical data; no new data or studies requested.
- LIVMARLI is under review for treatment of cholestatic pruritus in PFIC patients.
- Company notes no additional FDA information requests beyond the major amendment.

Source:
  EDGAR index:    https://www.sec.gov/Archives/edgar/data/1759425/000119312523257711/0001193125-23-257711-index.htm
  Primary doc:    https://www.sec.gov/Archives/edgar/data/1759425/000119312523257711/d548350d8k.htm
  HTML page:      https://secwatch.observer/filing/0001193125-23-257711

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