secwatch.observer — SEC 8-K summary
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Issuer:     MADRIGAL PHARMACEUTICALS, INC. (MDGL)
CIK:        0001157601
Form:       8-K
Filed at:   2023-06-30T23:59:59+00:00
Accession:  0001193125-23-179440
Event type: regulatory
Sentiment:  positive
Materiality: 0.75
Item codes: 8.01, 9.01
LLM model:  deepseek-v4-flash:cloud@v2

Madrigal initiates rolling NDA for resmetirom in NASH with liver fibrosis
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- Initiated rolling NDA submission to FDA seeking accelerated approval for resmetirom for NASH with liver fibrosis.
- Expects to complete full NDA submission in July 2023; will request priority review.
- Resmetirom granted Breakthrough Therapy designation in April 2023 for NASH with liver fibrosis.
- NDA based on MAESTRO-NASH biopsy trial meeting both histological improvement endpoints proposed by FDA.
- Resmetirom has potential to become first approved therapy for NASH with liver fibrosis if approved.

Source:
  EDGAR index:    https://www.sec.gov/Archives/edgar/data/1157601/000119312523179440/0001193125-23-179440-index.htm
  Primary doc:    https://www.sec.gov/Archives/edgar/data/1157601/000119312523179440/d502542d8k.htm
  HTML page:      https://secwatch.observer/filing/0001193125-23-179440

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