Servier’s $1.55 B Edgewise muscular dystrophy trial fails to meet primary and secondary endpoints

Servier invested roughly $1.55 billion in Edgewise Therapeutics' muscular dystrophy program and, five months after the deal, announced that the pivotal phase 2 trial in Becker muscular dystrophy did not achieve its goals.

The study enrolled 175 adult patients who received daily oral doses of sevasemten for 18 months. At the end of the trial, participants showed no statistically significant improvement over placebo on the North Star Ambulatory Assessment, resulting in a missed primary endpoint and also missing the predefined secondary endpoints.

Although the drug demonstrated a favorable safety and tolerability profile, Servier said the topline readout lacked any encouraging efficacy signals. The company plans to analyze the data in more depth and will release the full results later, while reaffirming its commitment to the program.