Madrigal Q3 2022 Earnings Report
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.