Amylyx Pharmaceuticals, Inc. announced Phase II/III results for AMX0035 in the treatment of amyotrophic lateral sclerosis (ALS) last year and hoped to obtain US Food and Drug Administration approval as soon as possible. Now the company has raised $135m in series C venture capital to fund regulatory submissions and conduct a Phase III clinical trial, but the timing of a US filing remains yet to be determined.
Cambridge, MA-based Amylyx said in September that ALS patients treated with AMX0035 in the Phase II/III CENTAUR trial had a slower rate of disease progression than patients who received a placebo