Business
Amylyx Pharmaceuticals Reports First Quarter 2022 Financial Results
˗ Final stages of commercial launch readiness underway to support the launch of AMX0035 for the treatment of ALS in the U.S. and Canada, if approved - Data
About this update from Amylyx Pharmaceuticals, Inc.
[{"type":"text","content":"\n˗ Final stages of commercial launch readiness underway to support the launch of AMX0035 for the treatment of ALS in the U.S. and Canada, if approved\n\n- Data published in Muscle & Nerve further demonstrate significant benefit of AMX0035 on survival in Phase 2 CENTAUR trial participants\n\n CAMBRIDGE, Mass.--(BUSINESS WIRE)--\nAmylyx Pharmaceuticals, Inc. (Nasdaq: AMLX) (“Amylyx” or the “Company”) today reported financial results for the quarter ended March 31, 2022.\n\n“We are encouraged by the overall progress Amylyx made over the first quarter of 2022. We are continuing to engage with regulators throughout the review process to move AMX0035 toward potential regulatory approvals as quickly and efficiently as possible,” said Josh Cohen, Co-CEO and Co-Founder of Amylyx. “We remain confident in the safety and efficacy data on AMX0035. These data have been published in the New England Journal of Medicine and Muscle & Nerve, and as we have heard from the ALS community, there is a crucial need for new and effective treatments in ALS.”\n\nJustin Klee, Co-CEO and Co-Founder of Amylyx, added, “We plan to be ready for a commercial launch in the United States and Canada over the next few months if we receive regulatory approvals. Our team has worked tirelessly as we know time is of the essence for people living with ALS and their families.”\n\nFirst Quarter 2022 and Year-to-Date Business Highlights:\n\n\nRegulatory applications under review for AMX0035 for the treatment of amyotrophic lateral sclerosis (ALS) in the U.S., Canada, and Europe.\n\n\nNew Drug Application (NDA) for AMX0035 for the treatment of ALS under Priority Review by the U.S. Food and Drug Administration (FDA). The Prescription Drug User Fee Act (PDUFA) date is June 29, 2022. The FDA held a Peripheral and Central Nervous System Drugs Advisory Committee (PCNSDAC) meeting on March 30, 2022. On the question, “Do the data from the single randomized, controlled trial and the open-label extension study [Phase 2 CENTAUR trial] establish a conclusion that sodium phenylbutyrate/taurursodiol [AMX0035] is effective in the treatment of patients with amyotrophic lateral sclerosis (ALS)?”, the PCNSDAC voted 4 yes votes and 6 no votes.\n\n\nNew Drug Submission for AMX0035 for the treatment of ALS under review by Health Canada.\n\n\nMarketing Authorisation Application for AMX0035 for t...