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Mar 31, 2023
Madrigal Q1 2023 Earnings Report
Madrigal reported financial results and corporate updates for Q1 2023.
Key Takeaways
Madrigal Pharmaceuticals reported its Q1 2023 financial results, highlighting progress in regulatory preparations, disease education, and market access strategy, with resmetirom's NDA filing on track for Q2 2023 and Breakthrough Therapy designation from the FDA.
Resmetirom new drug application (NDA) filing on track for Q2 2023.
Resmetirom has received Breakthrough Therapy designation from FDA.
Multiple resmetirom abstracts accepted for presentation at EASL, including primary results and additional data from the Phase 3 MAESTRO-NASH trial
The MAESTRO-NASH registrational trial in noncirrhotic NASH has completed enrollment.
Forward Guidance
Madrigal is currently conducting four Phase 3 clinical trials to demonstrate the safety and efficacy of resmetirom for the treatment of NASH: MAESTRO-NASH, MAESTRO-NAFLD-1, MAESTRO-NAFLD-OLE, and MAESTRO-NASH-OUTCOMES.
Positive Outlook
- Resmetirom new drug application (NDA) filing on track for Q2 2023
- Resmetirom has received Breakthrough Therapy designation from FDA
- The MAESTRO-NASH registrational trial in noncirrhotic NASH has completed enrollment
- Patient recruitment remains focused on MAESTRO-NASH-OUTCOMES
- Resmetirom has the potential to be a cost-effective treatment for patients with at-risk NASH
Challenges Ahead
- Risks of obtaining and maintaining regulatory approvals, including potential regulatory delays or rejections
- Risks associated with meeting the objectives of Madrigal’s clinical studies, including Madrigal’s ability to achieve enrollment objectives concerning patient numbers
- Any delays or failures in enrollment, and the occurrence of adverse safety events
Historical Earnings Impact
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Avg. Return Before/After Earnings
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