Business
Amylyx Pharmaceuticals Reports Full Year 2021 Financial Results
˗ Preparations underway to support potential commercial launch of AMX0035 for the treatment of ALS in the U.S. and Canada, if approved ˗ FDA assigned PDUFA
About this update from Amylyx Pharmaceuticals, Inc.
[{"type":"text","content":"\n˗ Preparations underway to support potential commercial launch of AMX0035 for the treatment of ALS in the U.S. and Canada, if approved\n\n˗ FDA assigned PDUFA action date of June 29, 2022\n\n CAMBRIDGE, Mass.--(BUSINESS WIRE)--\nAmylyx Pharmaceuticals, Inc. (Nasdaq: AMLX) (“Amylyx” or the “Company”) today reported financial results for the full year ended December 31, 2021.\n\n“2021 was a transformative year for Amylyx as we successfully executed against several clinical and regulatory milestones,” said Justin Klee and Josh Cohen, Co-CEOs and Co-Founders of Amylyx. “There is an urgent need for new treatments in ALS, and we believe we have made meaningful progress in developing the first drug candidate that has demonstrated the potential to both improve function and extend life. If approved, we look forward to making AMX0035 available to as many eligible people living with ALS as possible. We look forward to continuing to engage with regulators and expanding our pipeline, including research of AMX0035 in additional indications.”\n\nJames Frates, Chief Financial Officer of Amylyx added, “After a successful IPO, we began 2022 with a strong balance sheet and resources to support commercial launch preparations for AMX0035 for people living with ALS and to advance our research in neurodegenerative diseases.”\n\nFull Year 2021 and Year-to-Date 2022 Business Highlights:\n\n\nSubmitted regulatory applications for AMX0035 for the treatment of ALS to regulatory authorities in the U.S., Europe, and Canada, which were accepted for review.\n\n\nReceived U.S. Food and Drug Administration (FDA) acceptance and Priority Review of New Drug Application (NDA) for AMX0035 for the treatment of amyotrophic lateral sclerosis (ALS). The FDA assigned a Prescription Drug User Fee Act (PDUFA) date of June 29, 2022 and today held a Peripheral and Central Nervous System Drugs Advisory Committee (PCNSDAC) meeting to review the Company’s NDA for AMX0035 for the treatment of ALS.\n\n\nAnnounced European Medicines Agency validation of Marketing Authorisation Application for AMX0035 for the treatment of ALS. The application is now under review with the Committee for Medicinal Products for Human Use.\n\n\nAnnounced Health Canada accepted for review the New Drug Submission for AMX0035 for the treatment of ALS.\n\n\n\n\nAnnounced launch of an Expanded Access Progra...