Amylyx Pharmaceuticals Inc.
Amylyx Pharmaceuticals is dedicated to developing innovative treatments for neurodegenerative diseases with a focus on high unmet needs. The company emphasizes rigorous science, community engagement, and rapid development of therapies to improve patient outcomes. Their mission is rooted in connection, collaboration, and a commitment to addressing some of medicine's toughest challenges.
Industries
Nr. of Employees
large (251-1000)
Amylyx Pharmaceuticals Inc.
Patents
Products
ALBRIOZA™
An oral fixed-dose medication approved with conditions to treat amyotrophic lateral sclerosis (ALS) in Canada, with marketing applications pending in the U.S. and EU. It may reduce neuronal cell death by mitigating ER stress and mitochondrial dysfunction.
AMX0035
A proprietary oral fixed-dose combination of sodium phenylbutyrate and taurursodiol, designed to slow or mitigate neurodegeneration in ALS and other neurodegenerative diseases. It is approved in the U.S. as RELYVRIO® and in Canada as ALBRIOZA™ with conditions.
AMX0114
An antisense oligonucleotide targeting calpain-2, aimed at reducing axonal degeneration in ALS. It has shown promising preclinical results and is under development.
ALBRIOZA™
An oral fixed-dose medication approved with conditions to treat amyotrophic lateral sclerosis (ALS) in Canada, with marketing applications pending in the U.S. and EU. It may reduce neuronal cell death by mitigating ER stress and mitochondrial dysfunction.
AMX0035
A proprietary oral fixed-dose combination of sodium phenylbutyrate and taurursodiol, designed to slow or mitigate neurodegeneration in ALS and other neurodegenerative diseases. It is approved in the U.S. as RELYVRIO® and in Canada as ALBRIOZA™ with conditions.
AMX0114
An antisense oligonucleotide targeting calpain-2, aimed at reducing axonal degeneration in ALS. It has shown promising preclinical results and is under development.
News & Updates
Alberta will reimburse ALBRIOZA™ for ALS treatment through the public drug benefit list, effective August 1, 2023. The company is working to expand coverage across Canada.
A 48-week, randomized, placebo-controlled Phase 3 trial evaluating avexitide for post-bariatric hypoglycemia, with topline results expected in 2024.
A global trial with 664 participants, with topline results anticipated in 2024, designed to evaluate safety and efficacy of AMX0035 for ALS.
The EMA has validated Amylyx's MAA for AMX0035 for ALS, with review ongoing. The trial data from CENTAUR supports this application.
Amylyx acquired avexitide from Eiger BioPharmaceuticals, which has FDA Breakthrough Therapy Designation for PBH and congenital hyperinsulinism. The Phase 3 program is expected to begin in Q1 2025.
Alberta will reimburse ALBRIOZA™ for ALS treatment through the public drug benefit list, effective August 1, 2023. The company is working to expand coverage across Canada.
A 48-week, randomized, placebo-controlled Phase 3 trial evaluating avexitide for post-bariatric hypoglycemia, with topline results expected in 2024.
A global trial with 664 participants, with topline results anticipated in 2024, designed to evaluate safety and efficacy of AMX0035 for ALS.
The EMA has validated Amylyx's MAA for AMX0035 for ALS, with review ongoing. The trial data from CENTAUR supports this application.
Amylyx acquired avexitide from Eiger BioPharmaceuticals, which has FDA Breakthrough Therapy Designation for PBH and congenital hyperinsulinism. The Phase 3 program is expected to begin in Q1 2025.