Amylyx Pharmaceuticals Receives Notification of PDUFA Date Extension for AMX0035 for the Treatment of ALS

Amylyx Pharmaceuticals, Inc. (NASDAQ: AMLX) (Amylyx or the Company) today announced that the U.S. Food and Drug Administration (FDA) has extended the review timeline of the New Drug Application (NDA) for AMX0035 (sodium phenylbutyrate [PB] and taurursodiol [TURSO; also known as ursodoxicoltaurine]) for the treatment of amyotrophic lateral sclerosis (ALS). The updated Prescription Drug User Fee Act (PDUFA) goal date is September 29, 2022.

https://www.nasdaq.com/press-release/amylyx-pharmaceuticals-receives-notification-of-pdufa-date-extension-for-amx0035-for