Amylyx Plans to File for Approval of AMX0035 in US

Amylyx Plans to File for Approval of AMX0035 in US

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Amylyx Plans to File for Approval of AMX0035 in US

Amylyx Pharmaceuticals plans to submit a new drug application (NDA) to the U.S. Food and Drug Administration (FDA) in the coming months for approval of its investigational oral therapy AMX0035 for amyotrophic lateral sclerosis (ALS). The decision follows recent discussions with the FDA, including a pre-NDA meeting held July 15, and is a U-turn from the agency’s previous decision, which requested data from a large Phase 3 clinical trial called PHOENIX (NCT05021536) before considering AMX0035…

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