secwatch.observer — SEC 8-K summary
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Issuer:     MADRIGAL PHARMACEUTICALS, INC. (MDGL)
CIK:        0001157601
Form:       8-K
Filed at:   2022-12-19T23:59:59+00:00
Accession:  0001193125-22-307935
Event type: other_material
Sentiment:  positive
Materiality: 0.95
Item codes: 7.01, 8.01
LLM model:  deepseek-v4-flash:cloud@v2

Madrigal Phase 3 MAESTRO-NASH meets dual primary endpoints; NDA planned H1 2023
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- NASH resolution endpoint met: 30% on 100mg vs 10% placebo (p<0.0001); fibrosis improvement: 26% vs 14% (p=0.0002).
- LDL-C lowering at 24 weeks: -16% on 100mg vs -1% placebo (p<0.0001); both doses statistically significant.
- Safety similar across arms: SAEs 11.8-12.7%; discontinuation low (2.8-7.7%); common AEs mild diarrhea and nausea.
- Company plans to file NDA for accelerated approval (Subpart H) in first half of 2023.

Source:
  EDGAR index:    https://www.sec.gov/Archives/edgar/data/1157601/000119312522307935/0001193125-22-307935-index.htm
  Primary doc:    https://www.sec.gov/Archives/edgar/data/1157601/000119312522307935/d423141d8k.htm
  HTML page:      https://secwatch.observer/filing/0001193125-22-307935

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