Press Releases

RELYVRIO (previously known as AMX0035 in the U.S. ) is an oral, fixed-dose combination therapy for the treatment of adults with ALS RELYVRIO significantly slowed loss of physical function in a randomized, placebo-controlled clinical trial in ALS Detailed data from the CENTAUR clinical trial were...

CAMBRIDGE, Mass. --(BUSINESS WIRE)--Sep. 14, 2022-- Amylyx Pharmaceuticals, Inc. today announced that the donated clinical data from the placebo arm of the CENTAUR clinical trial that evaluated the safety, efficacy, and survival benefits of AMX0035 in adult participants with amyotrophic lateral...

CAMBRIDGE, Mass. --(BUSINESS WIRE)--Sep. 12, 2022-- Amylyx Pharmaceuticals, Inc. (NASDAQ: AMLX) (“Amylyx” or the “Company”) today announced the publication of preclinical data showing the effect of sodium phenylbutyrate (PB) and taurursodiol (TURSO, also known as ursodoxicoltaurine) on the...

- FDA   Advisory Committee voted 7:2 that the available evidence of effectiveness is sufficient to support approval of AMX0035 for the treatment of ALS - If approved, AMX0035 will be the first treatment in ALS that has demonstrated a significant slowing of disease progression and functional...

Second FDA Advisory Committee Meeting to Discuss NDA for AMX0035 for the Treatment of ALS CAMBRIDGE, Mass. --(BUSINESS WIRE)--Sep. 7, 2022-- Amylyx Pharmaceuticals, Inc. (Nasdaq: AMLX) (“Amylyx” or the “Company”) today announced that Nasdaq has halted trading of the Company’s common stock....

CAMBRIDGE, Mass. --(BUSINESS WIRE)--Sep. 2, 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 reconvened Peripheral and Central Nervous System Drugs Advisory Committee...

˗ ALBRIOZA™ (also known as AMX0035) now commercially available in Canada , representing first product launch for Amylyx ˗ FDA Advisory Committee meeting to review new drug application for AMX0035 for the treatment of ALS scheduled for September 7, 2022 ; assigned PDUFA action date of September 29,...

CAMBRIDGE, Mass. --(BUSINESS WIRE)--Aug. 3, 2022-- Amylyx Pharmaceuticals, Inc. (Nasdaq: AMLX) today announced that the U.S. Food and Drug Administration’s (FDA) Peripheral and Central Nervous System Drugs Advisory Committee (PCNSDAC) will reconvene to review the New Drug Application (NDA) for...

CAMBRIDGE, Mass. --(BUSINESS WIRE)--Jul. 29, 2022-- Amylyx Pharmaceuticals, Inc. (NASDAQ: AMLX) (“Amylyx” or the “Company”) today announced that ALBRIOZA™ (sodium phenylbutyrate and ursodoxicoltaurine) is now commercially available in Canada for people living with amyotrophic lateral sclerosis...

Project to support identification of Bax and Bak inhibitor therapeutic candidates with the potential to treat ALS and other neurodegenerative diseases CAMBRIDGE, Mass. --(BUSINESS WIRE)--Jul. 18, 2022-- Amylyx Pharmaceuticals, Inc. (NASDAQ: AMLX) (“Amylyx” or the “Company”) today announced a...

CAMBRIDGE, Mass. --(BUSINESS WIRE)--Jul. 6, 2022-- Amylyx Pharmaceuticals, Inc. (Nasdaq: AMLX) (“Amylyx” or the “Company”) today announced a poster on the ongoing international Phase 3 PHOENIX trial (study A35-004, NCT05021536 ) of AMX0035 (sodium phenylbutyrate [PB] and taurursodiol [TURSO; also...

CAMBRIDGE, Mass. --(BUSINESS WIRE)--Jul. 5, 2022-- Amylyx Pharmaceuticals, Inc. (Nasdaq: AMLX) (“Amylyx” or the “Company”) today announced that the U.S. Food and Drug Administration (“FDA” or the “Agency”) has informed the Company that the Agency is planning to reconvene the Peripheral and Central...

Health Canada decision signifies the first global regulatory approval for Amylyx and the first new therapy for ALS approved in Canada since 2018 ALBRIOZA (also known as AMX0035) is an oral fixed-dose combination therapy that may reduce neuronal cell death as a stand-alone therapy or when added to...

New PDUFA goal date scheduled for September 29, 2022 to allow time to review additional data CAMBRIDGE, Mass. --(BUSINESS WIRE)--Jun. 3, 2022-- Amylyx Pharmaceuticals, Inc. (NASDAQ: AMLX) (“Amylyx” or the “Company”) today announced that the U.S. Food and Drug Administration (FDA) has extended the...

CAMBRIDGE, Mass. --(BUSINESS WIRE)--May 26, 2022-- Amylyx Pharmaceuticals, Inc. (Nasdaq: AMLX) (“Amylyx” or the “Company”) announced today that a new post hoc analysis measuring substantial individual response to AMX0035 (sodium phenylbutyrate [PB] and taurursodiol [TURSO; also known as...

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...