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Mar 31, 2023
Edgewise Therapeutics Q1 2023 Earnings Report
Edgewise Therapeutics reported financial results for the first quarter of 2023 and recent business highlights.
Key Takeaways
Edgewise Therapeutics started 2023 by advancing its LYNX and CANYON clinical trials of EDG-5506 and completing IND-enabling studies of EDG-7500. They plan to share 12-month ARCH open label data and interim Duchenne data from the Phase 2 LYNX trial and initiate a potentially registration-enabling cohort in CANYON and a Phase 1 trial for EDG-7500.
Advanced Phase 2 trials of EDG-5506 in Becker muscular dystrophy (BMD, CANYON) and Duchenne muscular dystrophy (DMD, LYNX).
Advanced exercise challenge study of EDG-5506 in Limb girdle muscular dystrophy 2I, BMD and McArdle Disease (LGMD2I/R9, BMD, McArdle, DUNE).
Advanced IND-enabling studies of EDG-7500, a novel sarcomere modulator for hypertrophic cardiomyopathy (HCM); Phase 1 start expected in 2H2023.
Cash, cash equivalents and marketable securities of $328 million as of March 31, 2023.
Forward Guidance
Edgewise Therapeutics anticipates sharing 12-month ARCH open label data and interim Duchenne data from its Phase 2 LYNX trial during the remainder of 2023. They plan to initiate a potentially registration-enabling cohort in CANYON and a Phase 1 trial for EDG-7500 in healthy volunteers.
Positive Outlook
- Sharing 12-month ARCH open label data.
- Sharing interim Duchenne data from Phase 2 LYNX trial.
- Initiating a potentially registration-enabling cohort in CANYON.
- Initiating a Phase 1 trial for EDG-7500 in healthy volunteers.
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