The U.S. Food and Drug Administration (FDA) has extended the review of New Drug Application (NDA) by three months, submitted by Amylyx Pharmaceuticals (NASDAQ:AMLX) for its lead drug candidate AMX0035 with regard to the treatment of patients with amyotrophic lateral sclerosis (ALS).
The regulatory agency has assigned Standard Review for the application and set a new PDUFA target action date of 29th September 2022.
