Amylyx warns EMA unlikely to approve ALS drug AMX0035

31 May 2023

Shares of US biotech Amylyx Pharmaceuticals (Nasdaq: AMLX) fell more than 3% by close of trading Tuesday and a further 2.2% to $23.51 in pre-market activity today, after it said that a European regulatory panel had taken a negative view on its amyotrophic lateral sclerosis (ALS) treatment, so delaying the company's plans on introducing its first commercial drug in the region.

The European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) has been reviewing Amylyx’ marketing authorization application for AMX0035 (sodium phenylbutyrate and ursodoxicoltaurine [also known as taurursodiol]) for the treatment of adults with amyotrophic lateral sclerosis (ALS).

However, 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 authorization of AMX0035.

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