By Colin Kellaher


Amylyx Pharmaceuticals on Thursday said it is pulling its Relyvrio/Albrioza drug for amyotrophic lateral sclerosis, or ALS, from the market and slashing its workforce by 70%.

Amylyx said it is working with the U.S. Food and Drug Administration and Health Canada to remove the drug from the U.S. and Canada markets based on the failed Phase 3 study results the Cambridge, Mass., company reported last month.

The FDA approved Relyvrio in 2022 based on data from a Phase 2 study, but Amylyx last month said a confirmatory Phase 3 trial failed to meet its primary endpoint in patients with ALS, the neurodegenerative disorder commonly known as Lou Gehrig's disease.

Amylyx, which has been selling the drug as Albrioza in Canada under a conditional approval, said the drug will no longer be available for new patients, but that a free drug program will be available to those currently using it.

Amylyx said its board has approved a restructuring plan that includes a 70% reduction in its workforce and is aimed at extending its cash runway into 2026. The company has 384 employees, according to data from FactSet.

Amylyx said it expects to complete the restructuring by the end of the third quarter, adding that it will post severance and severance-related charges of around $19 million.

Amylyx said it continues to advance AMX0035 in Wolfram syndrome and in progressive supranuclear palsy and AMX0114 in ALS.


Write to Colin Kellaher at colin.kellaher@wsj.com


(END) Dow Jones Newswires

04-04-24 0800ET