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Amylyx Pharma: FDA Plans To Reconvene Advisory Committee To Review AMX0035 NDA On Sept. 7

Amylyx Pharmaceuticals, Inc. (AMLX) announced the FDA is planning to reconvene the Peripheral and Central Nervous System Drugs Advisory Committee to discuss the New Drug Application for AMX0035 for the treatment of amyotrophic lateral sclerosis on September 7, 2022. The PDUFA target action date for the AMX0035 NDA is September 29, 2022.

Tammy Sarnelli, Global Head of Regulatory Affairs of Amylyx, said: "We are pleased that the members of the advisory panel will review additional analyses from our clinical studies, including recently published analyses, supporting the previously reported functional and overall survival benefit for AMX0035."

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