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FDA Panel Votes in Favor of Amylyx Pharmaceuticals' (AMLX) AMX0035 ALS Drug
September 8, 2022 11:57 AM EDT(Updated - September 8, 2022 12:01 PM EDT)
Amylyx Pharmaceuticals (NASDAQ: AMLX) shares surged Thursday after it announced Thursday that the U.S. Food and Drug Administrations (FDA) Peripheral and Central Nervous System Drugs Advisory Committee voted in favor of approval for AMX0035, stating the evidence supports the effectiveness of the drug.
The drug is used to treat amyotrophic lateral sclerosis (ALS). The vote count saw seven of the committee vote yes and two vote no. However, panel recommendations are not binding but will be considered by the FDA when it... More
Amylyx Pharmaceuticals (AMLX) Announces FDA Ad Comm Backing of ALS Drug AMX0035
September 8, 2022 6:15 AM EDTAmylyx Pharmaceuticals, Inc. (Nasdaq: AMLX) announced today that the U.S. Food and Drug Administrations (FDA) Peripheral and Central Nervous System Drugs Advisory Committee (PCNSDAC) voted (7 yes votes and 2 no votes) that the available evidence of effectiveness is sufficient to support approval of AMX0035 (sodium phenylbutyrate and taurursodiol [also known as ursodoxicoltaurine]) for the treatment of amyotrophic lateral sclerosis (ALS).
The PCNSDACs decision was... More
