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.
"We are confident in the potential of AMX0035 to help people living with ALS and other neurodegenerative diseases, and we continue to work closely with the FDA as they complete their review," said Justin Klee and Joshua Cohen, Co-CEOs and Co-Founders of Amylyx.
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Amylyx Pharmaceuticals is a clinical-stage pharmaceutical company working on developing a novel therapeutic for amyotrophic lateral sclerosis and other neurodegenerative diseases.
According to data from Benzinga Pro, Amylyx Pharmaceuticals has a 52-week high of $33.41 and a 52-week low of $6.51.
