Amylyx Files for European Approval of AMX0035 in Treating ALS

Amylyx Files for European Approval of AMX0035 in Treating ALS

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Amylyx Files for European Approval of AMX0035 in Treating ALS

Amylyx Pharmaceuticals has filed an application with the European Medicines Agency seeking the approval of its lead candidate AMX0035 as a treatment of amyotrophic lateral sclerosis (ALS), the company announced in a press release. The marketing authorization request follows similar submissions to Health Canada and the U.S. Food and Drug Administration. U.S. regulators recently placed the application on priority review, and a decision is expected on or before June 29. AMX0035 is a fixed-dose formulation of…

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