Press Releases

Adding to previously reported overall functional and survival benefit data for AMX0035, these findings support effect of AMX0035 on disease progression in ALS Randomization to AMX0035 resulted in a lower occurrence of death or tracheostomy/permanent assisted ventilation by 49% and first...

˗ Final stages of commercial launch readiness underway to support the launch of AMX0035 for the treatment of ALS in the U.S. and Canada , if approved - Data published in Muscle & Nerve further demonstrate significant benefit of AMX0035 on survival in Phase 2 CENTAUR trial participants CAMBRIDGE,...

An analysis using the rank-preserving structural failure time model (RPSFTM), a method frequently employed in oncology to account for placebo crossover, estimated a 10.6-month longer median survival duration for AMX0035 participants Participants randomized to receive AMX0035 and who continued into...

- Summary of data from CENTAUR and PEGASUS showed AMX0035 was safe and well tolerated in clinical trials in   amyotrophic lateral sclerosis (ALS) and Alzheimer’s disease (AD) - Majority of treatment-emergent adverse events (TEAEs) associated with AMX0035 were gastrointestinal in both trials with no...

˗ Preparations underway to support potential commercial launch of AMX0035 for the treatment of ALS in the U.S. and Canada , if approved ˗ FDA assigned PDUFA action date of June 29, 2022 CAMBRIDGE, Mass. --(BUSINESS WIRE)--Mar. 30, 2022-- Amylyx Pharmaceuticals, Inc....

CAMBRIDGE, Mass. --(BUSINESS WIRE)--Mar. 30, 2022-- Amylyx Pharmaceuticals, Inc. (Nasdaq: AMLX) (“Amylyx” or the “Company”) announced today the outcome of the U.S. Food and Drug Administration’s (FDA) Peripheral and Central Nervous System Drugs Advisory Committee (PCNSDAC) meeting to review the...

FDA Advisory Committee Meeting to Discuss NDA for AMX0035 for the Treatment of ALS CAMBRIDGE, Mass. --(BUSINESS WIRE)--Mar. 30, 2022-- Amylyx Pharmaceuticals, Inc. (Nasdaq: AMLX) today announced that Nasdaq has halted trading of the company’s common stock. The U.S....

CAMBRIDGE, Mass. --(BUSINESS WIRE)--Mar. 28, 2022-- Amylyx Pharmaceuticals, Inc. (Nasdaq: AMLX) (“Amylyx” or the “Company”) today announced that the U.S. Food and Drug Administration (FDA) posted briefing documents for the March 30, 2022   Peripheral and Central Nervous System Drugs Advisory...

CAMBRIDGE, Mass. --(BUSINESS WIRE)--Mar. 18, 2022-- Amylyx Pharmaceuticals, Inc. (NASDAQ: AMLX) (“Amylyx” or the “Company”) announced today the launch of an Expanded Access Program (EAP) for AMX0035 (sodium phenylbutyrate [PB] and taurursodiol [TURSO; also known as ursodoxicoltaurine]) in the U.S....

CAMBRIDGE, Mass. --(BUSINESS WIRE)--Feb. 25, 2022-- Amylyx Pharmaceuticals, Inc. (Nasdaq: AMLX) (“Amylyx” or the “Company”), today announced that its Marketing Authorisation Application (MAA) to the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) for AMX0035...

CAMBRIDGE, Mass. --(BUSINESS WIRE)--Feb. 23, 2022-- Amylyx Pharmaceuticals, Inc. , (Nasdaq: AMLX) (“Amylyx” or the “Company”), today announced the appointment of Gina M. Mazzariello as Amylyx’ Chief Legal Officer (CLO) and General Counsel, where she will oversee all legal and compliance matters for...

CAMBRIDGE, Mass. --(BUSINESS WIRE)--Feb. 16, 2022-- Amylyx Pharmaceuticals, Inc. (Nasdaq: AMLX) today announced that a virtual meeting of the U.S. Food and Drug Administration’s (FDA) Peripheral and Central Nervous System Drugs Advisory Committee to review the New Drug Application (NDA) for AMX0035...

CAMBRIDGE, Mass. --(BUSINESS WIRE)--Feb. 10, 2022-- Amylyx Pharmaceuticals, Inc. (Nasdaq: AMLX) today announced that Joshua Cohen and Justin Klee , Co-CEOs and Co-Founders of Amylyx, will present at the 11 th Annual SVB Leerink Global Healthcare...

CALGARY, Alberta & TORONTO--(BUSINESS WIRE)-- The Canadian Neuromuscular Disease Registry (CNDR), an independent, academic registry based out of the University of Calgary, and Amylyx Pharmaceuticals (NASDAQ: AMLX) today announced...

Amylyx Pharmaceuticals, Inc. (“Amylyx”), a clinical-stage pharmaceutical company working on developing a novel therapeutic for amyotrophic lateral sclerosis (ALS) and other neurodegenerative diseases, today announced the pricing of its upsized...

Amylyx Pharmaceuticals, Inc. today announced it has submitted a Marketing Authorization Application (MAA) to the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) for AMX0035 (sodium phenylbutyrate (PB) and...

Amylyx Pharmaceuticals, Inc. (“Amylyx”), a clinical-stage pharmaceutical company working on developing a novel therapeutic for amyotrophic lateral sclerosis (ALS) and other neurodegenerative diseases, today announced the launch of its initial...