As a result of a significant approval, Amylyx Pharmaceuticals Inc. (Nasdaq: AMLX) shares rose 9.34% in after-hours trading to $33.11. The stock rose 3.28% to close Thursday’s trading at $30.19, trading 1.09 million shares..
AMLX has received what kind of approval?
The US Food and Drug Administration (FDA) has approved Amylyx Pharmaceuticals (AMLX)’s RELYVRIO (sodium phenylbutyrate and taurursodiol) for treating adults with amyotrophic lateral sclerosis (ALS). According to a randomized, placebo-controlled clinical trial, RELYVRIO significantly slowed the loss of physical function in people with ALS. The medication can be taken alone or in combination with existing treatments approved for ALS.
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It is a neurodegenerative disease caused by the death of motor neurons in the brain and spinal cord, which is relentlessly progressive and fatal. As ALS progresses, muscle function deteriorates, speech and movement become impossible, respiratory paralysis occurs, and death occurs. There are approximately 29,000 people in the United States who suffer from ALS, and 90% of these people have a sporadic disease with no clear family history.
A Phase 2 clinical trial involving 137 participants with ALS, CENTAUR, which incorporated a 6-month randomized, placebo-controlled phase and a long-term open-label extension (OLE), led to the approval of RELYVRIO. In the New England Journal of Medicine, Muscle & Nerve, and Journal of Neurology, Neurosurgery, and Psychiatry, detailed data on CENTAUR were published.
It was found that diarrhea, abdominal pain, nausea, and upper respiratory infections were the most common adverse events associated with RELYVRIO (at least 15% and at least 5% more common than placebo). During the first three weeks of treatment, gastrointestinal-related adverse reactions were more prevalent.
Following the approval, how ACTX will proceed:
Amylyx Pharmaceuticals (AMLX) decided to price RELYVRIO below the latest FDA-approved treatment available to people with ALS after considering the input of many stakeholders across the country. Through the Amylyx Care Team (ACT) Support Program, AMLX will provide support to healthcare professionals, people living with ALS, and their loved ones so that everyone who is eligible for RELYVRIO can receive it. RELYVRIO, prescribed by ACT, offers ALS patients and their families a dedicated, single point of contact to guide them throughout the treatment process.