ALS Breakthrough: Amylyx Stock Soars with FDA Fast Track!

Amylyx Pharmaceuticals, Inc. rose 1.60% in premarket trading, with the company receiving U.S. FDA Fast Track designation for AMX0114, an investigational antisense oligonucleotide targeting calpain-2 for the treatment of amyotrophic lateral sclerosis (ALS). The FDA's Fast Track designation is designed to facilitate the development and expedited review of therapies that are intended to treat serious and life-threatening conditions and demonstrate the potential to address an unmet medical need.