secwatch.observer — SEC 8-K summary
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Issuer:     MADRIGAL PHARMACEUTICALS, INC. (MDGL)
CIK:        0001157601
Form:       8-K
Filed at:   2023-09-13T23:59:59+00:00
Accession:  0001193125-23-234385
Event type: regulatory
Sentiment:  positive
Materiality: 0.85
Item codes: 8.01, 9.01
LLM model:  deepseek-v4-flash:cloud@v2

FDA accepts Madrigal's NDA for resmetirom for NASH with fibrosis, grants Priority Review
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- PDUFA target action date set for March 14, 2024; FDA not currently planning an advisory committee meeting.
- Priority Review shortens review to 6 months vs standard 10 months for a serious condition.
- NDA supported by positive Phase 3 MAESTRO-NASH biopsy endpoints and large safety database from 18 studies.
- Resmetirom is a once-daily oral THR-β agonist targeting key underlying causes of NASH in the liver.

Source:
  EDGAR index:    https://www.sec.gov/Archives/edgar/data/1157601/000119312523234385/0001193125-23-234385-index.htm
  Primary doc:    https://www.sec.gov/Archives/edgar/data/1157601/000119312523234385/d475156d8k.htm
  HTML page:      https://secwatch.observer/filing/0001193125-23-234385

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