---
schema_version: "secwatch.filing_event.v1"
accession: "0001193125-23-179440"
form_type: "8-K"
ticker: "MDGL"
cik: "0001157601"
company_name: "MADRIGAL PHARMACEUTICALS, INC."
filed_at: "2023-06-30T23:59:59+00:00"
generated_at: "2026-06-13T13:43:43.441372+00:00"
event_type: "regulatory"
sentiment: "positive"
materiality_score: 0.75
calibrated_materiality_score: 0.75
confidence: "high"
source: SEC EDGAR
---

# Madrigal initiates rolling NDA for resmetirom in NASH with liver fibrosis

## Summary
- 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.

## SEC filing metadata
- accession: 0001193125-23-179440
- form_type: 8-K
- ticker: MDGL
- cik: 0001157601
- company_name: MADRIGAL PHARMACEUTICALS, INC.
- filed_at: 2023-06-30T23:59:59+00:00
- event_type: regulatory
- sentiment: positive
- materiality_score: 0.75
- calibrated_materiality_score: 0.75
- confidence: high
- sec_items: 8.01, 9.01
- EDGAR index: https://www.sec.gov/Archives/edgar/data/1157601/000119312523179440/0001193125-23-179440-index.htm
- EDGAR primary document: https://www.sec.gov/Archives/edgar/data/1157601/000119312523179440/d502542d8k.htm

## Machine-readable alternates
- HTML: https://secwatch.observer/filing/0001193125-23-179440
- JSON: https://secwatch.observer/filing/0001193125-23-179440.json
- Plain text: https://secwatch.observer/filing/0001193125-23-179440.txt

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