(Reuters) -Amylyx Pharmaceuticals said on Friday its approved treatment for a neurological disorder called amyotrophic lateral sclerosis failed in a late-stage trial, sending its shares crashing 75% before the bell.
The U.S. Food and Drug Administration approved the drug, branded as Relyvrio, in September 2022 based on mid-stage trial data that showed the drug slowed progression of the disease and extended life expectancy by nearly 10 months.
ALS, also known as Lou Gehrig’s disease, breaks down nerve cells in the brain and spinal cord that make muscles work, leading to progressive paralysis and death.
Amylyx said it intends to engage with regulatory authorities over the next eight weeks to discuss the results and will share plans for the drug which may include voluntarily withdrawing it from the market.
(Reporting by Mariam Sunny in Bengaluru; Editing by Sriraj Kalluvila)
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