Amylyx announces upcoming AdCom meeting on ALS therapy
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Amylyx Pharmaceuticals (NASDAQ:AMLX) announced on Wednesday that the U.S. Food and Drug Administration (FDA) is set to hold an Advisory Committee meeting to decide on its marketing application for AMX0035, an experimental drug for amyotrophic lateral sclerosis (ALS).
According to the company, the regulatorâs Peripheral and Central Nervous System Drugs Advisory Committee is scheduled to hold the meeting on Mar. 30 to review the New Drug Application (NDA) ahead of the PDUFA date on Jun. 30. The FDA has already granted the Priority Review for the marketing application.
AMX0035 is an oral combination of sodium phenylbutyrate (PB) and taurursodiol (TURSO or ursodoxicoltaurine). 
Amylyx (AMLX) which made its public debut this year has become an M&A target, according to a list prepared by Goldman Sachs and Biogen (NASDAQ:BIIB)
on potential candidates for takeover.