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).
More moments
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Everything we do at Amylyx is centered around those living with neurodegenerative diseases. In a relentless pursuit to preserve every moment, we’re working to discover and develop new treatments with the potential to give people more quality time with the ones they love.
And this
And this
Because these are the moments that truly matter.
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.
Driven by People
“When you're diagnosed with ALS [amyotrophic lateral sclerosis], you're no longer on the human clock, you're on the ALS clock. Every passing day is a lifetime to an ALS patient, and ALS patients don't have time to wait.”
Cali, ALS caregiver
“I feel like Amylyx is a very different company than most that I work with and truly seems like a company that cares, with a big heart, but further than that is they have a fierceness in them and they’re not going to back down from so many of the obstacles that people living with ALS have been facing.”
Sandy, Person living with ALS
“I believe in Amylyx, I think they are truly patient-centric. They don't talk the talk, they walk the walk.”
Gwen, Person living with ALS
“You require help, that in the years prior, you never needed — where people have to change their lifestyle, to make your lifestyle. So, it doesn't just affect you, it affects the ones around you.”
Greg, Person living with ALS
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