Amylyx Pharmaceuticals' (AMLX) Relyvrio Receives Approval from FDA

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Go back to Amylyx Pharmaceuticals' (AMLX) Relyvrio Receives Approval from FDA

Amylyx Pharmaceuticals (AMLX) Sets List Price of $12,500 for 28-Day Supply of ALS Drug Relyvrio -- WSJ

September 30, 2022 8:49 AM EDT

Amylyx Pharmaceuticals (NASDAQ: AMLX) Sets List Price of $12,500 for 28-Day Supply of ALS Drug Relyvrio -- WSJ

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Amylyx Pharmaceuticals (AMLX) Confirms FDA Approval of RELYVRIO for the Treatment of ALS

September 30, 2022 7:05 AM EDT

Amylyx Pharmaceuticals, Inc. (NASDAQ: AMLX) (Amylyx or the Company) today announced that the U.S. Food and Drug Administration (FDA) has approved RELYVRIO (sodium phenylbutyrate and taurursodiol) for the treatment of adults with amyotrophic lateral sclerosis (ALS). RELYVRIO (previously known as AMX0035 in the U.S.) significantly slowed the loss of physical function in people living with ALS in a randomized, placebo-controlled clinical trial. RELYVRIO can be taken as a monotherapy or with existing approved treatments.

Todays FDA approval of RELYVRIO is an exciting milestone for the ALS community and is a major step... More