Amylyx Pharmaceuticals recently announced that it has submitted a New Drug Application for AMX0035 to the US Food and Drug Administration for the treatment of amyotrophic lateral sclerosis (ALS). AMX0035 is a combination of sodium phenylbutyrate (PB) and taurursodiol (TURSO) that was the subject of the CENTAUR trial, and the application for approval is a major step forward.

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The CENTAUR trial was led by Sabrina Paganoni, MD, PhD, Merit Cudkowicz, MD, MSc and the coordination center at the Sean M. Healey & AMG Center for ALS. It enrolled people with ALS across the country as part of the Northeast ALS Consortium, including at Mass General.