---
schema_version: "secwatch.filing_event.v1"
accession: "0001193125-23-187698"
form_type: "8-K"
ticker: "MDGL"
cik: "0001157601"
company_name: "MADRIGAL PHARMACEUTICALS, INC."
filed_at: "2023-07-17T23:59:59+00:00"
generated_at: "2026-06-13T07:30:22.931726+00:00"
event_type: "regulatory"
sentiment: "positive"
materiality_score: 0.85
calibrated_materiality_score: 0.85
confidence: "high"
source: SEC EDGAR
---

# Madrigal completes NDA submission to FDA for resmetirom for NASH with liver fibrosis

## Summary
- Completed rolling NDA submission to FDA for resmetirom for NASH with liver fibrosis; priority review requested.
- Phase 3 MAESTRO-NASH met both primary liver biopsy endpoints: NASH resolution and fibrosis reduction.
- Resmetirom granted Breakthrough Therapy designation by FDA in April 2023.
- Two ongoing Phase 3 outcomes studies (MAESTRO-NASH-OUTCOMES, MAESTRO-NAFLD-OLE) to support full approval.
- No approved therapy exists for NASH; resmetirom targets key underlying causes as THR-β agonist.

## SEC filing metadata
- accession: 0001193125-23-187698
- form_type: 8-K
- ticker: MDGL
- cik: 0001157601
- company_name: MADRIGAL PHARMACEUTICALS, INC.
- filed_at: 2023-07-17T23:59:59+00:00
- event_type: regulatory
- sentiment: positive
- materiality_score: 0.85
- calibrated_materiality_score: 0.85
- confidence: high
- sec_items: 8.01, 9.01
- EDGAR index: https://www.sec.gov/Archives/edgar/data/1157601/000119312523187698/0001193125-23-187698-index.htm
- EDGAR primary document: https://www.sec.gov/Archives/edgar/data/1157601/000119312523187698/d508608d8k.htm

## Machine-readable alternates
- HTML: https://secwatch.observer/filing/0001193125-23-187698
- JSON: https://secwatch.observer/filing/0001193125-23-187698.json
- Plain text: https://secwatch.observer/filing/0001193125-23-187698.txt

This AI-assisted summary is a reading aid. Review the linked SEC EDGAR filing before relying on any specific claim.