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Jun 30, 2024
Edgewise Therapeutics Q2 2024 Earnings Report
Reported financial results for the second quarter of 2024 and recent business highlights.
Key Takeaways
Edgewise Therapeutics reported second quarter 2024 financial results, highlighting progress in their cardiac and skeletal muscle programs. Key activities included completing the Phase 1 trial of EDG-7500 and advancing the Phase 2 CIRRUS-HCM trial. The company also continued to advance the GRAND CANYON global pivotal cohort and Phase 2 LYNX and FOX trials for sevasemten.
Completed Phase 1 SAD and MAD trial of EDG-7500 in healthy volunteers.
Continued dosing patients in Phase 2 CIRRUS-HCM trial of EDG-7500 in individuals with oHCM.
Continued to advance GRAND CANYON global pivotal cohort of sevasemten in adults with Becker.
Advanced Phase 2 LYNX and FOX trials of sevasemten in children with Duchenne.
Edgewise Therapeutics
Edgewise Therapeutics
Forward Guidance
Edgewise Therapeutics is focusing on advancing its clinical trials for EDG-7500 and sevasemten, with data readouts expected in the near term and a planned Phase 3 trial in Duchenne muscular dystrophy.
Positive Outlook
- Topline data of EDG-7500 from the Phase 1 trial in healthy volunteers and from the single dose arm of CIRRUS-HCM (Part A) in patients with obstructive HCM (three cohorts across different doses) in September.
- CANYON data is expected to be reported in the fourth quarter of 2024.
- LYNX data is expected to be reported, including safety, PK, changes in biomarkers of muscle damage and functional changes in NSAA and SV95C in the fourth quarter of 2024.
- Phase 3 trial in Duchenne, planned to be initiated in the first half of 2025.
- Exceptional enthusiasm from the Duchenne community for FOX trial.
Challenges Ahead
- Clinical trials are subject to delays and uncertainties.
- Data from clinical trials may not be positive or sufficient for regulatory approval.
- Regulatory approval processes are lengthy, time consuming and inherently unpredictable.
- Company's products are early in development and not having products approved for commercial sale
- Company has not generated any revenue to date