
Amylyx Pharmaceuticals Inc (NASDAQ:AMLX) shares are trading higher by 37.67% at $13.45 after the company announced the FDA extended the review timeline of the New Drug Application for AMX0035.
Amylyx says the FDA extended the PDUFA date to allow more time to review additional analyses of data from the Company's clinical studies. Amylyx added that 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.