Amylyx Pharmaceuticals announces intention to submit marketing authorisation application for its investigational amyotrophic lateral sclerosis (ALS) therapy AMX0035 to European Medicines Agency

The submission expected by end of 2021 is based on 24-week CENTAUR study of AMX0035 in 137 participants with ALS which met its primary endpoint of slowing ALS progression, as measured by the ALS Functional Rating Scale-Revised (ALSFRS-R). Phase III trial is planned for late 2021.

PharmaTimes