Free Trial

Madrigal Pharmaceuticals (MDGL) FDA Events

Madrigal Pharmaceuticals logo
$314.64 +6.05 (+1.96%)
Closing price 04:00 PM Eastern
Extended Trading
$315.23 +0.59 (+0.19%)
As of 05:14 PM Eastern
Extended trading is trading that happens on electronic markets outside of regular trading hours. This is a fair market value extended hours price provided by Polygon.io. Learn more.
FDA Events for Madrigal Pharmaceuticals (MDGL)

This section highlights FDA-related milestones and regulatory updates for drugs developed by Madrigal Pharmaceuticals (MDGL). Over the past two years, Madrigal Pharmaceuticals has reported clinical trial outcomes, regulatory submissions, approvals, and other FDA events for drugs and therapies such as Resmetirom and Resmetirom. For definitions of regulatory abbreviations such as NDA, BLA, or PDUFA, see the event status legend.

Madrigal Pharmaceuticals' Drugs in FDA Review

Resmetirom (MAESTRO-NAFLD-1) - FDA Regulatory Timeline and Events

Resmetirom (MAESTRO-NAFLD-1) is a drug developed by Madrigal Pharmaceuticals for the following indication: Nonalcoholic steatohepatitis (NASH). This drug is under review by the U.S. Food and Drug Administration (FDA). Below is a timeline of key regulatory milestones for this therapy.

Resmetirom (MAESTRO-NASH) - FDA Regulatory Timeline and Events

Resmetirom (MAESTRO-NASH) is a drug developed by Madrigal Pharmaceuticals for the following indication: Non-alcoholic steatohepatitis (NASH) and liver fibrosis. This drug is under review by the U.S. Food and Drug Administration (FDA). Below is a timeline of key regulatory milestones for this therapy.

Madrigal Pharmaceuticals FDA Events - Frequently Asked Questions

However, the company does has had drugs under review or in active clinical development.

In the past two years, Madrigal Pharmaceuticals (MDGL) has reported FDA regulatory activity for the following drugs: Resmetirom (MAESTRO-NASH) and Resmetirom (MAESTRO-NAFLD-1).

The most recent FDA-related event for Madrigal Pharmaceuticals occurred on June 20, 2025, involving Resmetirom (MAESTRO-NASH). The update was categorized as "Positive Opinion," with the company reporting: "Madrigal Pharmaceuticals, Inc. announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has adopted a positive opinion recommending approval of resmetirom (Rezdiffra) for the treatment of adults with noncirrhotic MASH with moderate to advanced liver fibrosis."

Current therapies from Madrigal Pharmaceuticals in review with the FDA target conditions such as:

  • Non-alcoholic steatohepatitis (NASH) and liver fibrosis - Resmetirom (MAESTRO-NASH)
  • Nonalcoholic steatohepatitis (NASH) - Resmetirom (MAESTRO-NAFLD-1)

More FDA Event Resources from MarketBeat

  • NDA: New Drug Application
  • ANDA: Abbreviated New Drug Application
  • sNDA: Supplemental New Drug Application
  • BLA: Biologics License Application
  • sBLA: Supplemental Biologics License Application
  • FDA Approved: Approved by the FDA
  • EMA: European Medicines Agency
  • CE Mark: European Union Certification
  • NMPA: China National Medical Products Administration
  • MHLW: Japanese Ministry of Health
  • FDA Meeting: Consultation with FDA
  • Pre-IND: Pre-Investigational New Drug Meeting
  • Breakthrough Therapy: Special FDA designation for promising therapies
  • Fast Track: Accelerated FDA approval pathway
  • Orphan Drug: Designation for rare disease treatments
  • RPD: Rare Pediatric Disease Designation
  • RMAT: Regenerative Medicine Advanced Therapy
  • DSMB Review: Data Safety Monitoring Board Review
  • IDMC Review: Independent Data Monitoring Committee
  • MAA: MHRA Marketing Authorization Application
  • RTF: Refusal to File (Rejected Application)
  • 510(k): FDA Clearance for Medical Devices
  • Rolling Submission: Staggered regulatory review process

This page (NASDAQ:MDGL) was last updated on 7/10/2025 by MarketBeat.com Staff
From Our Partners