Amylyx 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).
The 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.
The 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.
https://finance.yahoo.com/news/amylyx-pharmaceuticals-announces-posting-briefing-161500681.html
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