Amylyx Pharmaceuticals Receives FDA Fast Track Designation for AMX0114 in ALS
Amylyx Pharmaceuticals announced that the FDA has granted Fast Track designation to its investigational antisense oligonucleotide (ASO), AMX0114, for the treatment of amyotrophic lateral sclerosis (ALS). The candidate targets calpain-2, an enzyme linked to axonal degeneration, a critical driver of ALS progression.
“Obtaining FDA Fast Track designation for AMX0114 is an important step forward in our mission to develop potential treatments for people living with ALS, a relentlessly progressive and fatal disease with limited therapeutic options,” said Dr. Camille L. Bedrosian, Chief Medi...