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Everything we do at Amylyx is centered around those living with neurodegenerative diseases. We're working to discover and develop new treatments with the potential to give people more quality time with the ones they love.

FDA Acceptance for Review New Drug Application (NDA) for AMX0035

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).

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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