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Amylyx Pharmaceuticals Announces Posting of Briefing Documents for Second FDA Advisory Committee Meeting on AMX0035
CAMBRIDGE, Mass.--(BUSINESS WIRE)-- Amylyx Pharmaceuticals, Inc. (Nasdaq: AMLX) (“Amylyx or the “Company”) today announced that 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) (“Amylyx or the “Company”) today announced that the U.S. Food and Drug Administration (FDA) posted briefing documents for the reconvened Peripheral and Central Nervous System Drugs Advisory Committee (PCNSDAC) meeting to review the New Drug Application (NDA) for AMX0035 (sodium phenylbutyrate and taurursodiol [also known as ursodoxicoltaurine]) for the treatment of amyotrophic lateral sclerosis (ALS).\n\nThe second meeting of the PCNSDAC for the AMX0035 NDA is scheduled for 12:00 p.m. ET on Wednesday, September 7, 2022. The briefing materials and webcast information can be accessed here. The Company is not responsible for the content of, nor the statements made in, the briefing materials that were prepared by the FDA.\n\nThe PCNSDAC previously met on March 30, 2022 to discuss the NDA for AMX0035 for the treatment of ALS. The Prescription Drug User Fee Act (PDUFA) target action date for the NDA is September 29, 2022, which was extended by the FDA to allow more time to review additional analyses of data from the Company’s clinical studies.\n\nAbout AMX0035\nAMX0035 (sodium phenylbutyrate and taurursodiol) is an oral fixed-dose medication with marketing applications pending in the United States and European Union and approved with conditions as ALBRIOZA™ to treat amyotrophic lateral sclerosis (ALS) in Canada. The combination of sodium phenylbutyrate and taurursodiol may reduce neuronal cell death, hypothesized to occur by simultaneously mitigating endoplasmic reticulum stress and mitochondrial dysfunction. AMX0035 is also being explored for the potential treatment of other neurodegenerative diseases.\n\nAbout Amylyx Pharmaceuticals\nAmylyx Pharmaceuticals, Inc. is committed to supporting and creating more moments for the neurodegenerative community through the discovery and development of innovative new treatments. Amylyx is headquartered in Cambridge, Massachusetts and has operations in Canada and EMEA. For more information, visit amylyx.com and follow us on LinkedIn and Twitter. For investors, please visit investors.amylyx.com.\n\nForward-Looking Statements\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 ...