Amylyx Pharmaceuticals falls after US FDA withdraws approval for ALS drug

Amylyx Pharmaceuticals

28/08/2025 14:24

** Shares of drug developer Amylyx Pharmaceuticals AMLX.O fall 4.2% to $9.1 premarket

** U.S. FDA says it is withdrawing approval of co's ALS drug, Relyvrio

** FDA says Amylyx has voluntarily requested it to withdraw approval of this application and waived opportunity for hearing

** Co voluntarily withdrew drug from U.S. and Canada last year after failing in key late-stage trial

** The drug, also known as AMX0035, was approved by FDA in 2022 to treat amyotrophic lateral sclerosis, a neurodegenerative disease that affects nerve cells in brain and spinal cord

** Co said on Wednesday it is stopping development of AMX0035 for rare brain disorder

** Up to last close, stock more than doubled YTD

 (Reporting by Sneha S K)

 ((Sneha.SK@thomsonreuters.com))