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Edgewise Therapeutics
Edgewise Therapeutics (EWTX) investor relations material
Edgewise Therapeutics 44th Annual J.P. Morgan Healthcare Conference summary
Complete event summary combining all related documents: earnings call transcript, report, and slide presentation.44th Annual J.P. Morgan Healthcare Conference summary13 Jan, 2026
Key program updates and clinical progress
Completed enrollment in pivotal Becker study for sevasemten, with data readout expected by year-end and strong patient retention in open-label extensions.
Phase 2 and 3 studies in Becker muscular dystrophy show significant reduction in disease progression, with robust biomarker and functional endpoint data supporting efficacy.
Over-enrollment in pivotal Becker study (175 patients) increases statistical power, and commercial infrastructure is being built in anticipation of positive results.
Cardiovascular program EDG-7500 demonstrates strong efficacy and safety, with no reduction in ejection fraction, differentiating it from current therapies.
IND filed for second-generation cardiovascular asset (15400), with healthy volunteer studies completed and HFpEF trials planned for later this year.
Strategic vision and pipeline progress
Positioned as a global leader in muscle disease therapeutics, leveraging expertise in muscle biology and small molecule drug discovery.
Rapidly advancing a portfolio targeting muscular dystrophies and serious cardiac conditions, with a focus on patient-centric development.
Pipeline includes sevasemten for Becker and Duchenne muscular dystrophy, EDG-7500 for hypertrophic cardiomyopathy (HCM), and EDG-15400 for heart failure with preserved ejection fraction (HFPEF).
Anticipates becoming a commercial company in 2027, with key data readouts and regulatory submissions planned for 2026 and 2027.
Clinical milestones and data highlights
Positive topline data reported for sevasemten in Becker and Duchenne, and for EDG-7500 in HCM.
Pivotal GRAND CANYON trial for sevasemten in Becker completed enrollment; primary endpoint powered at >98% to show NSAA difference at 18 months.
Sevasemten demonstrated sustained stability in NSAA scores over three years, diverging positively from predicted declines.
EDG-7500 showed rapid, multi-domain improvement in HCM clinical manifestations, with minimal changes in LVEF and strong patient-reported outcomes.
Additional Duchenne muscular dystrophy data readout in Q2 to assess efficacy in more aggressive patient populations.
Becker: Strategy for non-ambulatory patient access?
HCM Phase III: Single study vs. active comparator?
HFpEF: Phase II design for smaller, focused study?
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Next Edgewise Therapeutics earnings date
Q4 202526 Feb, 2026
Edgewise Therapeutics
Next Edgewise Therapeutics earnings date
Q4 202526 Feb, 2026
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Frequently asked questions
Edgewise Therapeutics Inc. (EWTX) is a clinical-stage biopharmaceutical company dedicated to the discovery, development, and commercialization of innovative treatments for severe, rare muscle disorders, addressing significant unmet medical needs. Utilizing its proprietary drug discovery platform, Edgewise focuses on targeting the muscle as an organ, combining expertise in muscle biology and small molecule engineering. This approach allows the identification of precision medicines regulating key proteins in muscle tissue. Edgewise Therapeutics is headquartered in Boulder, Colorado, and its shares are listed on the Nasdaq.
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