Our Company

Josh Cohen and Justin Klee invent AMX0035, a proprietary combination of sodium phenylbutyrate (PB) and taurursodiol (TURSO, also known as ursodoxicoltaurine outside of the U.S.) hypothesized to simultaneously target two pathways that could slow progression in neurodegenerative diseases, and they co-found Amylyx.

Amylyx runs the first in vitro experiments of AMX0035 and demonstrates its synergistic potential. Dr. Rudy Tanzi, Vice-Chair of Neurology at Massachusetts General Hospital, joins Amylyx as Founding Chair of the Scientific Advisory Board (SAB).

Amylyx focuses its efforts on ALS in consultation with Dr. Tanzi; Dr. Merit Cudkowicz, Chief of the Massachusetts General Hospital Neurology Service, Director, Sean M. Healey & AMG Center for ALS at Massachusetts General Hospital, and the Julieanne Dorn Professor of Neurology at Harvard Medical School in Boston; and Peter Foss, President of ALS Finding a Cure.

Amylyx receives ALS ACT grant from ALS Association and ALS Finding a Cure, funded in part by the ALS Ice Bucket Challenge.

The first study participants are dosed in the Phase 2 CENTAUR clinical trial of AMX0035 for treating people living with ALS.

AMX0035 receives Orphan Drug Designation from the FDA for the treatment of ALS.

The first study participants are dosed in the Phase 2 PEGASUS clinical trial of AMX0035 for treating people living with Alzheimer’s disease.

The Phase 2 CENTAUR clinical trial of AMX0035 in ALS meets its primary endpoint.

AMX0035 receives Orphan Drug Designation from the European Medicines Agency for the treatment of ALS.

The CENTAUR results are published in The New England Journal of Medicine and Muscle & Nerve.

AMX0035 receives Orphan Drug Designation from the FDA for treatment of Wolfram syndrome.

The first study participants are dosed in the global Phase 3 PHOENIX clinical trial of AMX0035 for treating people living with ALS.

Amylyx’ New Drug Application is accepted in the U.S. for the review of AMX0035 in the treatment of ALS.

Amylyx completes successful IPO and begins trading on NASDAQ as $AMLX.

Expanded Access Program for AMX0035 launches in the U.S. for people living with ALS who meet program eligibility criteria.

Health Canada approves AMX0035 under the brand name ALBRIOZA™ with conditions for the treatment of ALS.

The FDA approves AMX0035 under the brand name RELYVRIO^® for the treatment of ALS in adults.

The first participant is dosed in the Phase 2 HELIOS clinical trial of AMX0035 for treating people living with Wolfram syndrome.

The first study participants are dosed in the Phase 3 ORION clinical trial of AMX0035 for treating people living with progressive supranuclear palsy (PSP).

The PHOENIX trial evaluating the safety and efficacy of AMX0035 in a larger and broader population of people living with ALS does not meet its prespecified primary endpoint. Amylyx starts a process with the FDA and Health Canada to voluntarily discontinue the marketing authorizations for RELYVRIO and ALBRIOZA and provide free access through early 2025 to people on therapy who decide, together with their doctor, to continue.

Amylyx announces positive interim data from ongoing Phase 2 HELIOS clinical trial of AMX0035 for treating people with Wolfram syndrome.

Amylyx adds avexitide, a Phase 3-ready glucagon-like peptide-1 (GLP-1) receptor antagonist with FDA Breakthrough Therapy designation, to its pipeline.

Amylyx announces positive topline data from Phase 2 HELIOS clinical trial of AMX0035 for treating people with Wolfram syndrome.