Core Viewpoint - Edgewise Therapeutics (EWTX) shares surged 30% in pre-market trading following positive top-line data for EDG-7500 from early-stage studies in healthy subjects and mid-stage studies in patients with obstructive hypertrophic cardiomyopathy (HCM) [1] Group 1: Clinical Data and Efficacy - EDG-7500 demonstrated no significant changes in left ventricle ejection fraction (LVEF) in phase I study participants, indicating a favorable safety profile [2][3] - In Part A of the phase II CIRRUS-HCM study, EDG-7500 treatment resulted in a 67% mean reduction in resting left ventricular outflow tract (LVOT) pressure gradient and a 55% mean reduction in provokable LVOT pressure gradient, without affecting LVEF [4] - The 200 mg cohort also showed a 64% mean reduction in NT-proBNP, a key heart failure biomarker, highlighting EDG-7500's potential for treating diastolic dysfunction diseases [4] Group 2: Development Plans - Edgewise has initiated dosing for the first patients with obstructive and non-obstructive HCM in Part B of the phase II CIRRUS-HCM study, addressing a significant unmet medical need [5] - The study will assess tolerability, pharmacokinetics, and effects on LVOT pressure gradient, LVEF, biomarkers, and patient function, with initial data expected in Q1 2025 [6] Group 3: Other Candidates - In addition to EDG-7500, Edgewise is evaluating its lead candidate, sevasemten, for Becker and Duchenne muscular dystrophies, which is a first-in-class fast myosin inhibitor [7]
EWTX Stock Soars on Upbeat Efficacy Data From Cardiomyopathy Studies