Amylyx Pharmaceuticals

Amylyx Pharmaceuticals is a U.S. biopharmaceutical company founded in 2013 and headquartered in Cambridge, Massachusetts. Co-founded by Joshua Cohen and Justin Klee, the company initially focused on neurodegenerative diseases, particularly amyotrophic lateral sclerosis (ALS). Its principal early-stage product, AMX0035, combined two established ingredients and was marketed as Relyvrio in the United States and Canada after receiving regulatory authorization for ALS. Relyvrio became the company’s central commercial product, but Amylyx announced in 2024 that it would withdraw the product from the U.S. and Canadian markets after a confirmatory clinical trial failed to meet its primary endpoint. The company subsequently redirected resources toward its broader neurodegenerative-disease pipeline, including a candidate for progressive supranuclear palsy. Amylyx remains an operating public biopharmaceutical company, although its commercial strategy changed substantially following the withdrawal of Relyvrio.

Amylyx Pharmaceuticals was founded in 2013 by Joshua Cohen and Justin Klee and is headquartered in Cambridge, Massachusetts. From its early years, the company focused on neurodegenerative diseases and built its main development platform around AMX0035. The therapy combines sodium phenylbutyrate and tauroursodeoxycholic acid and was developed to address processes associated with neuronal injury. In 2022, the U.S. Food and Drug Administration approved the therapy under the Relyvrio brand for ALS; it was later authorized in Canada under the Albrioza brand. This approval moved Amylyx from a primarily clinical-stage company into commercial operations. In 2023 and 2024, the company reported results from the PHOENIX confirmatory trial. After the trial failed to meet its primary efficacy endpoint, Amylyx announced in 2024 that it would voluntarily withdraw Relyvrio/Albrioza from the United States and Canadian markets and discontinue related commercial sales. Following the withdrawal, the company redirected resources toward its broader neurodegenerative-disease pipeline, including development work for progressive supranuclear palsy. Its history illustrates the transition of a research-focused biotechnology company into commercialization and then toward strategic and pipeline reconfiguration after an unfavorable confirmatory clinical outcome.

• 2024

  Withdrawal of Relyvrio/Albrioza

  [4]Amylyx announces voluntary withdrawal of Relyvrio/Albriozair.amylyx.com

  After the PHOENIX confirmatory trial failed to meet its primary endpoint, the company announced the withdrawal and discontinuation of sales in the US and Canada.

• 2022

  Relyvrio Approved in the US

  [3]FDA approves oral treatment for ALSfda.gov

  The FDA approved Relyvrio for the treatment of ALS, bringing Amylyx into the commercial stage.

• 2013

  Company Founded

  [2]Amylyx Pharmaceuticals — Company Informationir.amylyx.com

  Joshua Cohen and Justin Klee founded Amylyx Pharmaceuticals, focusing on developing therapies for neurodegenerative diseases.

• 2022

  Relyvrio

  Relyvrio was Amylyx’s combination therapy for neurodegenerative disease, containing sodium phenylbutyrate and tauroursodeoxycholic acid. It was approved in the United States for ALS before the company announced its withdrawal from the U.S. and Canadian markets in 2024.

• 2024

  Withdrawal of Relyvrio and R&D Focus AdjustmentStrategy

  Background

  The PHOENIX confirmatory trial for Relyvrio failed to meet its primary endpoint.

  Action taken

  The company announced the voluntary withdrawal of Relyvrio/Albrioza in the US and Canada, ceasing commercial sales and reallocating resources.

  Aftermath

  The company continues to advance other research programs in neurodegenerative diseases.

  Source

1. 1Amylyx Pharmaceuticals — Managementir.amylyx.com
2. 2Amylyx Pharmaceuticals — Company Informationir.amylyx.com
3. 3FDA approves oral treatment for ALSfda.gov
4. 4Amylyx announces voluntary withdrawal of Relyvrio/Albriozair.amylyx.com