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Amylyx Pharma: FDA Extends PDUFA Date For AMX0035 - Quick Facts

Amylyx Pharmaceuticals, Inc. (AMLX) announced the FDA has extended the review timeline of the New Drug Application for AMX0035 for the treatment of amyotrophic lateral sclerosis. The updated PDUFA goal date is September 29, 2022.

The FDA extended the PDUFA date to allow more time to review additional analyses of data from the clinical studies. The submission of the information has been determined by the FDA to constitute a major amendment to the NDA, resulting in an extension of the PDUFA goal date, the company noted.

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