Amylyx Raises $135M for Development of ALS Drug

Cambridge-based Amylyx Pharmaceuticals has closed a $135 million Series C financing to support the clinical development and potential launch plans for lead product candidate AMX0035, for the potential treatment of ALS, and further research and development in other neurodegenerative diseases. The financing was led by Viking Global Investors with participation from Bain Capital Life Sciences and others.

“We have a clear mission at Amylyx: to develop new medications for ALS and other progressive neurodegenerative diseases. We are eager to work with Viking and our syndicate of experienced biotechnology investors as we execute our plan to hopefully bring AMX0035 to people living with ALS as soon as possible,” said James Frates, Amylyx CFO.

Amylyx filed a New Drug Submission (NDS) for AMX0035 for the treatment of ALS with Health Canada in June. Amylyx intends to submit a Marketing Authorization Application (MAA) for AMX0035 to the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) by the end of 2021. Amylyx will continue to update the global ALS community on global regulatory plans including with the FDA and plans to initiate a Phase 3 clinical trial.

AMX0035 is an investigational product comprised of two complementary active agents which were combined in a co-formulation to reduce neuronal death and dysfunction. AMX0035 was specifically co-formulated and manufactured by Amylyx to ensure proper absorption, exposure, and quality. AMX0035 targets endoplasmic reticulum and mitochondrial-dependent neuronal degeneration pathways in ALS and other neurodegenerative diseases. (Source: Amylyx Pharmaceuticals Website, 20 July, 2021)