Core Viewpoint - Edgewise Therapeutics (EWTX) shares surged over 18% following positive mid-stage results from the CANYON study for its drug sevasemten, aimed at treating Becker Muscular Dystrophy (BMD) [1][5]. Group 1: Study Results - The CANYON study achieved its primary endpoint, showing a significant 28% reduction in creatine kinase (CK) levels in the sevasemten-treated group compared to placebo over six to twelve months [2]. - Sevasemten treatment indicated a trend towards improvement in the North Star Ambulatory Assessment, a key secondary endpoint, and showed a significant reduction in plasma levels of fast skeletal muscle troponin I (TNNI2) [3]. - The sevasemten-treated group had patients with more advanced disease compared to the placebo group, suggesting the drug's efficacy in a challenging patient population [3]. Group 2: Future Plans and Pipeline - Edgewise is on track to complete recruitment for the pivotal GRAND CANYON cohort by the first quarter of 2025, with plans to seek FDA and EMA approval for sevasemten if results are positive [4]. - Besides BMD, sevasemten is being evaluated for other muscular disorders, including Duchenne muscular dystrophy (DMD), Limb-Girdle muscular dystrophy (LGMD), and McArdle Disease [8]. - Edgewise is also developing another candidate, EDG-7500, for obstructive hypertrophic cardiomyopathy (HCM), with initial data expected in the first quarter of 2025 [9][11]. Group 3: Stock Performance - EWTX shares have increased nearly 200% year to date, contrasting with an 11.4% decline in the industry, reflecting investor confidence in the CANYON study results and the potential of sevasemten [6].
EWTX Stock Rises on Upbeat Data From Rare Muscular Disorder Study