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Sep 30, 2023
Madrigal Q3 2023 Earnings Report
Madrigal reported third quarter 2023 financial results and provided corporate updates.
Key Takeaways
Madrigal Pharmaceuticals reported its Q3 2023 financial results, highlighting the ongoing priority review of resmetirom's new drug application and a recent $500 million financing to support its potential launch. The company is preparing for a potential approval of resmetirom in March 2024 and will present new Phase 3 MAESTRO study data at the AASLD Liver Meeting.
FDA accepted the New Drug Application and granted Priority Review for resmetirom with a Prescription Drug User Fee Act date of March 14, 2024.
Bill Sibold was appointed Chief Executive Officer of Madrigal.
A public offering generated gross proceeds of $500 million to support the potential launch of resmetirom.
Multiple Madrigal abstracts from the Phase 3 MAESTRO program will be presented at the AASLD Liver Meeting.
Madrigal
Madrigal
Forward Guidance
Madrigal is preparing for the potential approval and launch of resmetirom, with key regulatory and commercial activities underway. The company anticipates presenting resmetirom data at the AASLD Liver Meeting and is focused on supporting clinicians in managing patients.
Positive Outlook
- Potential approval of resmetirom in March 2024.
- Largest and most advanced development program in NASH.
- Commercial strategy grounded in resmetirom’s profile as a liver-directed oral therapy.
- Resources necessary to execute a first-to-market launch of resmetirom in the U.S.
- Sharing new data and insights to help clinicians manage patients.
Challenges Ahead
- Risks of obtaining and maintaining regulatory approvals.
- Potential regulatory delays or rejections.
- Risks associated with meeting the objectives of Madrigal’s clinical studies.
- Any delays or failures in enrollment, and the occurrence of adverse safety events.
- Market demand and acceptance of our products.