---
schema_version: "secwatch.filing_event.v1"
accession: "0001193125-23-234385"
form_type: "8-K"
ticker: "MDGL"
cik: "0001157601"
company_name: "MADRIGAL PHARMACEUTICALS, INC."
filed_at: "2023-09-13T23:59:59+00:00"
generated_at: "2026-06-10T18:50:50.455327+00:00"
event_type: "regulatory"
sentiment: "positive"
materiality_score: 0.85
calibrated_materiality_score: 0.85
confidence: "high"
source: SEC EDGAR
---

# FDA accepts Madrigal's NDA for resmetirom for NASH with fibrosis, grants Priority Review

## Summary
- 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.

## SEC filing metadata
- accession: 0001193125-23-234385
- form_type: 8-K
- ticker: MDGL
- cik: 0001157601
- company_name: MADRIGAL PHARMACEUTICALS, INC.
- filed_at: 2023-09-13T23:59:59+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/1157601/000119312523234385/0001193125-23-234385-index.htm
- EDGAR primary document: https://www.sec.gov/Archives/edgar/data/1157601/000119312523234385/d475156d8k.htm

## Machine-readable alternates
- HTML: https://secwatch.observer/filing/0001193125-23-234385
- JSON: https://secwatch.observer/filing/0001193125-23-234385.json
- Plain text: https://secwatch.observer/filing/0001193125-23-234385.txt

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