sevasemten — NDA/BLA submission
H1 2027
GRAND CANYON, a global pivotal placebo-controlled cohort in Becker: GRAND CANYON is designed to assess the efficacy and safety of sevasemten over an 18-month period, with North Star Ambulatory Assessment (NSAA) as the primary endpoint. The study is highly powered to be able to show a statistically significant difference in NSAA versus placebo over 18 months. The Company expects to report top-line data in the fourth quarter of 2026 and is continuing preparations for a potential NDA submission to the U.S. Food and Drug Administration (FDA) for sevasemten in Becker, planned for the first half of 2027. To learn more about GRAND CANYON, go to clinicaltrials.gov ( NCT05291091 ).Source filing