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Sep 30, 2022
Madrigal Q3 2022 Earnings Report
Madrigal reported third quarter 2022 financial results and provided an overview of upcoming resmetirom data presentations.
Key Takeaways
Madrigal Pharmaceuticals reported its third quarter 2022 financial results, highlighting upcoming resmetirom Phase 3 data presentations. The company had cash, cash equivalents and marketable securities of $153.2 million as of September 30, 2022. Madrigal is focused on delivering topline data from the pivotal MAESTRO-NASH biopsy study in Q4 2022.
Madrigal remains on track to announce topline data from the Phase 3 MAESTRO-NASH biopsy study in the fourth quarter.
Two resmetirom oral abstracts to be presented at the AASLD Liver Meeting.
Madrigal had cash, cash equivalents and marketable securities of $153.2 million as of September 30, 2022.
Madrigal is pursuing Subpart H accelerated approval in the first half of 2023.
Madrigal
Madrigal
Forward Guidance
Madrigal is focused on delivering topline data from the pivotal MAESTRO-NASH biopsy study in Q4 2022 and plans to finalize their new drug application for resmetirom, with the goal of filing for Subpart H accelerated approval in the first half of 2023.
Positive Outlook
- Positive results from the MAESTRO-NASH study would allow Madrigal to finalize its new drug application for resmetirom.
- Madrigal aims to file for Subpart H accelerated approval in the first half of 2023.
- Efficacy and safety data from four Phase 3 MAESTRO studies put Madrigal in a strong position to navigate the accelerated approval pathway.
- Resmetirom has the potential to address the unmet needs of patients who currently have no approved therapy to treat NASH with significant fibrosis.
- The MAESTRO program continues to generate data that reinforce Madrigal's conviction in the potential of resmetirom to become a foundational therapy for patients with NASH.
Challenges Ahead
- Madrigal's ability to raise sufficient capital to fund ongoing operations as currently planned is uncertain.
- Outcomes or trends from competitive studies could impact Madrigal's prospects.
- Future topline data timing or results are uncertain.
- Achieving potential benefits in studies that include substantially more patients, and patients with different disease states, than prior studies poses risks.
- Limitations associated with early stage or non-placebo controlled study data could affect the assessment of resmetirom's efficacy.