New ALS option could get speedy US approval after all

Excited by the prospect of renewed regulatory support for amyotrophic lateral sclerosis (ALS) candidate AMX0035, investors bought up shares in Amylyx Pharmaceuticals (Nasdaq: AMLX) before the opening bell on Tuesday.

In April a key scientific panel of the US regulator  narrowly voted against accepting mid-stage data as proof of efficacy, with experts questioning the robustness of the results.

In a highly unusual move, experts will now reconvene to discuss the data again, focusing this time on additional analyses from studies which were “determined by the FDA to constitute a major amendment” to the submission, Amylyx said.