---
schema_version: "secwatch.filing_event.v1"
accession: "0001193125-24-068170"
form_type: "8-K"
ticker: "MDGL"
cik: "0001157601"
company_name: "MADRIGAL PHARMACEUTICALS, INC."
filed_at: "2024-03-15T23:59:59+00:00"
generated_at: "2026-06-04T16:39:01.413889+00:00"
event_type: "regulatory"
sentiment: "positive"
materiality_score: 1.0
calibrated_materiality_score: 1.0
confidence: "high"
source: SEC EDGAR
---

# Madrigal receives FDA accelerated approval for Rezdiffra, first NASH therapy

## Summary
- FDA grants accelerated approval for Rezdiffra in NASH with F2-F3 fibrosis; first approved therapy for NASH.
- Approval based on Phase 3 MAESTRO-NASH: improved fibrosis and NASH resolution at 52 weeks vs placebo.
- Prescribing info does not require liver biopsy; weight-based dosing (80mg <100kg, 100mg >=100kg).
- Rezdiffra expected available in US in April via specialty pharmacy; patient support programs.
- Most common adverse reactions: diarrhea, nausea, pruritus, abdominal pain. Continued approval contingent on confirmatory outcomes data.

## SEC filing metadata
- accession: 0001193125-24-068170
- form_type: 8-K
- ticker: MDGL
- cik: 0001157601
- company_name: MADRIGAL PHARMACEUTICALS, INC.
- filed_at: 2024-03-15T23:59:59+00:00
- event_type: regulatory
- sentiment: positive
- materiality_score: 1.0
- calibrated_materiality_score: 1.0
- confidence: high
- sec_items: 7.01, 8.01, 9.01
- EDGAR index: https://www.sec.gov/Archives/edgar/data/1157601/000119312524068170/0001193125-24-068170-index.htm
- EDGAR primary document: https://www.sec.gov/Archives/edgar/data/1157601/000119312524068170/d788116d8k.htm

## Machine-readable alternates
- HTML: https://secwatch.observer/filing/0001193125-24-068170
- JSON: https://secwatch.observer/filing/0001193125-24-068170.json
- Plain text: https://secwatch.observer/filing/0001193125-24-068170.txt

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