Business
Amylyx Pharmaceuticals Announces FDA Advisory Committee Meeting to Review New Drug Application for AMX0035 for the Treatment of ALS Scheduled for March 30, 2022
CAMBRIDGE, Mass.--(BUSINESS WIRE)-- Amylyx Pharmaceuticals, Inc. (Nasdaq: AMLX) today announced that a virtual meeting of the U.S. Food and Drug
About this update from Amylyx Pharmaceuticals, Inc.
[{"type":"text","content":" CAMBRIDGE, Mass.--(BUSINESS WIRE)--\nAmylyx Pharmaceuticals, Inc. (Nasdaq: AMLX) today announced that a virtual meeting of the U.S. Food and Drug Administration’s (FDA) Peripheral and Central Nervous System Drugs Advisory Committee to review the New Drug Application (NDA) for AMX0035 (sodium phenylbutyrate [PB] and taurursodiol [TURSO; also known as ursodoxicoltaurine]) has been scheduled for March 30, 2022. AMX0035 is an investigational therapy for the treatment of amyotrophic lateral sclerosis (ALS). As previously reported, the U.S. FDA has granted Priority Review and assigned a Prescription Drug User Fee Act date for AMX0035 of June 29, 2022.\n\n“There are few treatments approved for ALS, a devastating disease that impacts a person’s ability to move, speak, eat and breathe,” said Lahar Mehta, M.D., Head of Global Clinical Development of Amylyx. “We look forward to a robust scientific discussion with the members of the advisory committee panel regarding the clinical data submitted to support our New Drug Application for AMX0035.”\n\nAbout AMX0035\n\nAMX0035 is a proprietary oral fixed-dose combination of two small molecules: sodium phenylbutyrate (PB), which is a small molecular chaperone designed to reduce the unfolded protein response (UPR), preventing cell death resulting from the UPR, and taurursodiol (TURSO; also known as ursodoxicoltaurine), which is a Bax inhibitor designed to reduce cell death through apoptosis. PB and TURSO were combined in a fixed-dose formulation in an effort to reduce neuronal death and dysfunction. AMX0035 is designed to target the endoplasmic reticulum and mitochondrial-dependent neuronal degeneration pathways in ALS and other neurodegenerative diseases.\n\nAbout Amylyx Pharmaceuticals\n\nAmylyx Pharmaceuticals, Inc. is a clinical-stage biopharmaceutical company working on developing a novel therapeutic for amyotrophic lateral sclerosis (ALS) and other neurodegenerative diseases. For more information, visit www.amylyx.com and follow us on LinkedIn and Twitter. For investors please visit investors.amylyx.com.\n\nForward-Looking Statements\n\nStatements contained in this press release regarding matters that are not historical facts are “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995, as amended. Because such statements are subject to risks an...