Business
Amylyx Pharmaceuticals Reports First Quarter 2023 Financial Results
˗ First quarter 2023 product revenue of $71.4 million; commercial launches of RELYVRIO® in U.S. and ALBRIOZA™ in Canada for the treatment of ALS continue to
About this update from Amylyx Pharmaceuticals, Inc.
[{"type":"text","content":"\n˗ First quarter 2023 product revenue of $71.4 million; commercial launches of RELYVRIO® in U.S. and ALBRIOZA™ in Canada for the treatment of ALS continue to progress\n\n\n˗ Regulatory review ongoing in the EU\n\n\n˗ Expansion of pipeline with first participant dosed in Phase 2 HELIOS study of AMX0035 in Wolfram syndrome and planned initiation of a pivotal Phase 3 study in progressive supranuclear palsy anticipated this year\n\n\n˗ Management to host conference call and webcast today at 4:30 p.m. Eastern Time\n\n\n CAMBRIDGE, Mass.--(BUSINESS WIRE)--\nAmylyx Pharmaceuticals, Inc. (Nasdaq: AMLX) (“Amylyx” or the “Company”) today reported financial results for the first quarter ended March 31, 2023.\n\n\n“During the first quarter, we made significant progress on our commercial launches of RELYVRIO in the U.S. and ALBRIOZA in Canada as we advanced our goal of ensuring efficient access for every eligible person living with ALS. We continue to see strong engagement and interest from physicians and the ALS community and are encouraged that the vast majority of payors who have published formal policy decisions are providing broad access to RELYVRIO. We remain focused on our key commercial priorities to drive awareness, educate payors, and help people gain access to therapy as quickly as possible,” said Joshua Cohen, co-CEO of Amylyx. “We also continue to engage with the European Medicines Agency as it reviews our Marketing Authorisation Application for AMX0035 and continue to expect a decision later this year.”\n\n\nJustin Klee, co-CEO of Amylyx, added, “We are pleased with our recent progress but understand there is much more work to be done to achieve our mission of one day ending the suffering caused by ALS and other neurodegenerative diseases. With this in mind, we are excited to announce our plans to initiate a new Phase 3 study of AMX0035 in progressive supranuclear palsy later this year, supported by findings from our PEGASUS Phase 2 study in Alzheimer’s disease as well as a number of preclinical studies which indicate the potential for AMX0035 to lower levels of tau, a biomarker often seen in people with neurodegenerative diseases, including PSP.”\n\n\nFirst Quarter 2023 and Recent Business Highlights:\n\n\n\nCommercial launches of RELYVRIO (sodium phenylbutyrate and taurursodiol) in the U.S. and ALBRIOZA (sodium phenylbutyrat...