Amylyx+Pharmaceuticals%2C+Inc. (NASDAQ: AMLX) (“Amylyx” or the “Company”) today announced an update on the ongoing review of its Marketing Authorisation Application (MAA) for AMX0035 (sodium phenylbutyrate and ursodoxicoltaurine [also known as taurursodiol]) for the treatment of adults with amyotrophic lateral sclerosis (ALS) by the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA). Following an oral explanation held at the May meeting of the CHMP, Amylyx was informed that the CHMP is trending toward a negative opinion on the application for conditional marketing authorisation of AMX0035.
Amylyx Pharmaceuticals Provides Update on Ongoing Regulatory Review of AMX0035 for the Treatment of ALS in the European Union
May 30, 2023
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