Business
Amylyx Pharmaceuticals Reports Third Quarter 2022 Financial Results
˗ RELYVRIO™ (sodium phenylbutyrate and taurursodiol) approved for the treatment of ALS in adults and now commercially available in the U.S., representing
About this update from Amylyx Pharmaceuticals, Inc.
[{"type":"text","content":"\n˗ RELYVRIO™ (sodium phenylbutyrate and taurursodiol) approved for the treatment of ALS in adults and now commercially available in the U.S., representing second product launch for Amylyx worldwide\n\n˗ Commercial launch of ALBRIOZA™ (sodium phenylbutyrate and ursodoxicoltaurine) in Canada continues to progress\n\n˗ Management to host conference call and webcast today at 4:30 p.m. Eastern Time\n\n CAMBRIDGE, Mass.--(BUSINESS WIRE)--\nAmylyx Pharmaceuticals, Inc. (Nasdaq: AMLX) (“Amylyx” or the “Company”) today reported financial results for the quarter ended September 30, 2022.\n\n“The third quarter has proven to be a transformative time for Amylyx and the ALS community, marked by the regulatory approval of our new oral therapy for the treatment of ALS in the United States and commercial availability of our first product in Canada,” said Joshua Cohen and Justin Klee, Co-CEOs of Amylyx. “We are thrilled that RELYVRIO and ALBRIOZA are now available to people living with ALS in the U.S. and Canada, and we are encouraged by the early trajectory of enrollment in our Amylyx Care Team (ACT) Support Program as well as the rate of new prescriptions for this important new therapeutic option. We continue to work expeditiously during the early stages of our commercial launch to ensure every eligible person living with ALS will gain access as quickly and efficiently as possible.”\n\nThird Quarter 2022 and Recent Business Highlights:\n\n\nAnnounced FDA approval of RELYVRIO™ (sodium phenylbutyrate and taurursodiol) for the treatment of adults with amyotrophic lateral sclerosis (ALS) on September 29. This decision represents Amylyx’ first regulatory approval in the U.S. and second worldwide. Shipments of RELYVRIO, previously known as AMX0035, commenced on October 24.\n\n\n\nAnnounced availability of ALBRIOZA™ (sodium phenylbutyrate and ursodoxicoltaurine) in Canada for the treatment of ALS. Commercial launch of ALBRIOZA, previously known as AMX0035, in Canada commenced on July 29. This announcement marked the first commercial availability of AMX0035 worldwide.\n\n\n\nMarketing Authorisation Application (MAA) for AMX0035 for the treatment of ALS under review with European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP). The Company has received the Rapporteurs Day 150 Joint Assessment Report, which is provided to ...