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Dec 31, 2024
Edgewise Therapeutics Q4 2024 Earnings Report
Edgewise Therapeutics reported fourth quarter and full year 2024 financial results and provided recent business highlights.
Key Takeaways
Edgewise Therapeutics reported positive Phase 2 CANYON results, completed enrollment in GRAND CANYON, and advanced CIRRUS-HCM in Q4 2024. The company's cash, cash equivalents, and marketable securities were approximately $470.2 million as of December 31, 2024.
Completed enrollment of the GRAND CANYON global pivotal study of sevasemten in Becker muscular dystrophy.
Announced positive top-line results from Phase 2 CANYON trial of sevasemten in Becker.
On track to report data from Phase 2 CIRRUS-HCM trial of EDG-7500 in Hypertrophic Cardiomyopathy in the first quarter of 2025.
On track to report data from the Phase 2 LYNX and FOX trials of sevasemten in Duchenne muscular dystrophy in the first half of 2025.
Edgewise Therapeutics
Edgewise Therapeutics
Forward Guidance
Edgewise Therapeutics anticipates several milestones in 2025, including data readouts from ongoing clinical trials and regulatory interactions.
Positive Outlook
- Reporting data from Phase 2 CIRRUS-HCM trial of EDG-7500 in HCM in Q1 2025.
- Reporting data from Phase 2 LYNX and FOX trials of sevasemten in Duchenne in the first half of 2025.
- Engaging the U.S. FDA in the first half of 2025 to discuss marketing authorization filing strategies for sevasemten in Becker.
- Filing an investigational new drug application for a novel candidate for the treatment of heart failure during 2025.
- Selecting a proprietary cardiometabolic drug candidate based on preclinical proof-of-concept data during 2025.
Challenges Ahead
- Potential risks associated with product candidates causing serious adverse events.
- Uncertainties related to regulatory approval processes.
- Risks related to reliance on third-party manufacturers.
- Risks related to not achieving adequate market acceptance.
- Dependence on the success of sevasemten and EDG-7500.