Amylyx jumps on PUDFA date extension for AMX0035 for ALS

6 June 2022

US biotech Amylyx Pharmaceuticals (Nasdaq: AMLX) saw its shares leap 25% to $12.24 in early trading Friday after the US Food and Drug Administration extended the review timeline for its amyotrophic lateral sclerosis treatment.

The FDA has extended the review timeline of the New Drug Application (NDA) for AMX0035 (sodium phenylbutyrate [PB] and taurursodiol [TURSO; also known as ursodoxicoltaurine]) for the treatment of amyotrophic lateral sclerosis (ALS). The updated Prescription Drug User Fee Act (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 company’s clinical studies. The submission of this information has been determined by the FDA to constitute a major amendment to the NDA, resulting in an extension of the PDUFA goal date.

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