Amylyx presses on with AMX0035 with new safety data

Last week was a tumultuous one for US company Amylyx Pharmaceuticals (Nasdaq: AMLX) and its amyotrophic lateral sclerosis (ALS) candidate, AMX0035, a fixed dose combination product of sodium phenylbutyrate and taurursodiol.

A key scientific panel of the US Food and Drug Administration (FDA) voted narrowly against accepting mid-stage data alone as proof of the therapy’s efficacy after briefing notes  revealed earlier in the week appeared to question the robustness of the available data.

"The results of this analysis provide additional insights and clarifications on the overall safety and tolerability of AMX0035"Amylyx’ share price dropped by almost half as investors assumed that this would mean the FDA would not approve AMX0035.