Amylyx (AMLX) Withdraws ALS Drug, Cuts Workforce by 70%

Core Viewpoint - Amylyx Pharmaceuticals is withdrawing its ALS drug Relyvrio from the U.S. and Canadian markets following the failure of the late-stage PHOENIX study, which significantly impacted the company's stock performance [1][2][5]. Company Developments - The PHOENIX study, a phase III clinical trial, did not meet its primary endpoint, leading to the decision to remove Relyvrio/Albrioza from the market for new patients, although current patients can transition to a free drug program [2][3]. - The company is restructuring, reducing its workforce by approximately 70% and focusing on key programs for AMX0035 in Wolfram syndrome and progressive supranuclear palsy (PSP) [3][4]. - Amylyx's shares have decreased by 81.2% year-to-date, contrasting with a 5.4% decline in the industry [3]. Clinical Trials and Future Focus - The ongoing PHOENIX Open Label Extension (OLE) and a phase III study, ORION, are evaluating AMX0035 for other neurodegenerative conditions [3][4]. - Interim data from the phase II HELIOS study of AMX0035 in Wolfram syndrome is expected to be presented later this month [3]. Historical Context - Relyvrio was initially approved by the FDA in 2022 based on phase II CENTAUR study data, which showed a significant slow-down in ALS progression [5].