Edgewise Therapeutics(US:EWTX)2025-12-03 21:57Summary of Edgewise Therapeutics FY Conference Call Company Overview - Company: Edgewise Therapeutics (NasdaqGS:EWTX) - Date of Conference: December 03, 2025 Key Accomplishments - CANYON Study: - First controlled study in Becker muscular dystrophy (BMD) population - Achieved primary endpoint with creatine kinase biomarker - Statistical significance on TNNI2 biomarker indicating muscle damage - Natural history data matched projections from the study, supporting a phase three trial [4][5] - Phase Three Trial: - Completed enrollment in February 2025 - 18-month study with 175 patients, 98% power to detect a 1.7-point change in North Star endpoint - Expected readout by November-December 2026 [5] EDG 7500 for HCM - Market Expansion: - Mavocamten has a run rate exceeding $1 billion but has not fully penetrated the market due to safety concerns [6][7] - EDG 7500 shows no changes in ejection fraction relative to drug concentration, differentiating it from current treatments [8][9] - Efficacy Data: - KCCQ scores showed significant improvements, with mid-20s for obstructive HCM and 16-point change for non-obstructive patients - Deep changes in NT-proBNP and rapid effects on E-prime observed [10] Safety Protocol Adjustments - Atrial Fibrillation (AFib) Risk Management: - Adjusted trial protocols to better evaluate patient risks for AFib - Multi-pronged approach for echo evaluations to ensure patient safety [11][12][13] - Enrollment and Data: - 29 patients enrolled in April update, with at least 40 patients expected for efficacy data in the first half of 2026 [16] Future Expectations - Phase Three Start: - Anticipated to begin in Q4 2026, with plans to potentially abbreviate timelines [36] - Becker Phase Three Data: - Aiming for a statistical significance threshold of 0.75 in the upcoming trial - Maintaining function over time is crucial for commercial success [37][38] Additional Insights - Community Market Opportunity: - Significant potential in community cardiology practices that are currently limited by echo monitoring requirements [28][29] - Patient-Centric Approach: - Emphasis on qualitative measures of patient well-being rather than solely relying on ejection fraction metrics [31][32] - AFib Rate Expectations: - Acceptable AFib rates in upcoming updates are expected to be in the single digits, based on historical placebo rates [35] This summary encapsulates the key points discussed during the conference call, highlighting Edgewise Therapeutics' achievements, ongoing trials, and future strategies in the context of Becker muscular dystrophy and hypertrophic cardiomyopathy.