Amylyx Pharmaceuticals, Inc. announced the Company has started a process with the U.S. Food and Drug Administration and Health Canada to voluntarily discontinue the marketing authorizations for RELYVRIO/ALBRIOZA and remove the product from the market in the U.S. and Canada based on topline results from the Phase 3 PHOENIX trial. RELYVRIO/ALBriOZA will no longer be available for new patients. Based on topline results from The Phase 3 PHOENIX study of AMX0035 in ALS, Amylyx has started a process with the FDA and Health Canada of voluntarily discontinuing the marketing authorizations for RELyVRIO/ALBBRIOZA will no longer beavailable for new patients as of today; Patients currently on therapy in the U.S. & Canada who, in consultation with their physician, wish to continue can be transitioned to a free drug program; PHOENIX Open Label Extension is ongoing; Amylyx continues to advance AMX0035 in Wolfram syndrome and in progressive supranuclear palsy (PSP), and AMX0114 in ALS; Interim data from the Phase 2 HELIOS trial of AMX0035 for the treatment of Wolfram syndrome are expected this month and will be presented during a webcast on April 10, 2024; Restructuring plan reduces workforce by approximately 70% to focus resources on key clinical and preclinical programs and extends expected cash runway into 2026, through anticipated data readouts for AMX0035 in Wolfam syndrome and PSP, and AMX0114 inALS.

The company look forward to presenting interim data from Phase 2 HELIOS study of AMX0035 In Wolfram syndrome, a rare, genetic, fatal neurodegenerative disease with no FDA-approved treatment options, later this month. The company expects to initiate a clinical trial studying AMX0114 in ALS in the second half of this year. Amylyx also announced a restructuring to focus the Company's financial resources on upcoming clinical milestones.

The Company will reduce its workforce by approximately 70% and decrease external financial commitments outside of its priority areas. HELIOS Interim Data in Wolfram Syndrome Investor Webcast Details. Amylyx will host a virtual webcast on April 10, 2022.

The company expects to initiate the clinical trial studying AMX01 14 in ALS in the second half the year. Amylyx also announce a restructuring to focus the Company' financial resources on upcoming clinical milestones".