Amylyx is proud to announce that the U.S. Food and Drug Administration has accepted for review our New Drug Application (NDA) for AMX0035 (sodium phenylbutyrate (PB) and taurursodiol (TURSO; also known as ursodoxicoltaurine)) for the treatment of amyotrophic lateral sclerosis (ALS).
FDA Acceptance for Review New Drug Application (NDA) for AMX0035
EMA Validation of MAA for AMX0035 for the Treatment of ALS
Amylyx is proud to announce that the European Medicines Agency (EMA) has validated our Marketing Authorisation Application (MAA) for AMX0035 for the treatment of ALS and is now reviewing our MAA.
In pursuit of more
Our ongoing commitment to discovery carries with it a responsibility to be transparent, set realistic expectations, and work together to make an impact. Learn about our unique culture, approach to clinical trials for AMX0035, and more.
Our ongoing commitment to discovery carries with it a responsibility to be transparent, set realistic expectations, and work together to make an impact. Learn about our unique culture, approach to clinical trials for AMX0035, and more.
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