Amylyx Pharmaceuticals, Inc.’s AMX0035 for the rare neurodegenerative disorder amyotrophic lateral sclerosis (ALS) is set for a US Food and Drug Administration decision on 29 June. The candidate is a proprietary combination of tauroursodeoxycholic acid and sodium phenylbutyrate designed to reduce mitochondrial and endoplasmic reticulum stress.
The filing was based on data from the pivotal CENTAUR trial, which enrolled 137 ALS patients and measured the co-primary...







