Amylyx Pharmaceuticals, Inc. announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) confirmed its initial negative opinion on the Marketing Authorisation Application (MAA) for AMX0035 (sodium phenylbutyrate and ursodoxicoltaurine [also known as taurursodiol), under the trade name ALBRIOZA®?, for the treatment of amyotrophic lateral sclerosis (ALS) in the European Union (EU). The decision follows the conclusion of the CHMP's formal re- examination procedure of an initial negative opinion adopted in June 2023. ALBRIOZA was approved with conditions by Health Canada in June 2022 and granted a full approval by the U.S. Food and Drug Administration (FDA) under the trade name RELYVRIO®?

in September 2022. Amylyx continues to focus on the completion of the PHOENIX Phase 3 clinical trial, which was initiated prior to its Marketing Authorisation Application submission and will provide additional data on the efficacy and safety profile of ALBRIOZA in people living with ALS. If PHOENIX is supportive, Amylyx plans to seek approval in the EU as quickly as possible.

PHOENIX is a 48-week, randomized placebo-controlled global Phase 3 clinical trial further evaluating the safety and efficacy of AMX0035 for the treatment of ALS. The design of PHOENIX was informed by the results of the Phase 2 CENTAUR clinical trial of AMX0035, which met itspecified primary outcome and demonstrated a statistically significant benefit in function as well as an observed benefit on survival in a longer-term post hoc analysis. CENTAUR was a multicenter Phase 2 clinical trial in 137 participants with ALS encompassing a 6-month randomized placebo-controlled phase and an open-label extension (OLE) long-term follow-up phase.