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Edge12 Dec 2025
Running on Clouds: The Story of On
The story of how a Swiss runner's pursuit of a new running sensation became On, aiming to be the most premium global sportswear brand worldwide.
Edgewise Therapeutics (EWTX) investor relations material
Edgewise Therapeutics Evercore ISI 8th Annual HealthCONx Conference summary
Complete event summary combining all related documents: earnings call transcript, report, and slide presentation.Evercore ISI 8th Annual HealthCONx Conference summary3 Dec, 2025
Key accomplishments and clinical progress
Achieved primary and secondary biomarker endpoints in the first controlled study for Becker muscular dystrophy, supporting a fully controlled phase 3 trial.
Phase 3 Becker trial completed enrollment in February; 18-month study with 175 patients, aiming for a readout in November–December 2026.
For HCM, demonstrated no relationship between drug concentration and ejection fraction, indicating a differentiated safety profile.
Robust efficacy data in HCM with significant improvements in KCCQ scores and NT-proBNP, showing rapid and deep effects.
Adjusted patient selection and triage in HCM trials to better match prior phase 3 studies and reduce AFib risk.
Protocol adjustments and safety measures
Implemented multi-level echo review (PI, internal expert, core lab) to ensure appropriate patient selection and minimize AFib risk.
Excluded patients with high AFib risk based on atrial size and reservoir strain, aligning with prior phase 3 criteria.
Ongoing part D of HCM study focuses on safety, with efficacy data from earlier parts and more details to be disclosed soon.
Acceptable AFib rates in upcoming updates are in the single digits, consistent with placebo rates in similar studies.
Dose finding and future plans
Enrolled additional cohorts at 25 mg to identify the minimally effective dose and inform phase 3 dosing strategy.
Dose titration in part D ranges from 25 up to 150 mg, with open-label extension to 200 mg, to guide phase 3 design.
Aim to demonstrate no need for echo monitoring, enabling broader adoption in community settings.
Phase 3 for HCM expected to start in Q4 2026, with potential for abbreviated timelines.
How does EDG-7500's LVEF profile expand market?
What AFib rate is acceptable for EDG-7500?
What North Star change is key for EDG-5506 market?
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Next Edgewise Therapeutics earnings date
Q4 202526 Feb, 2026
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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