New ALS option could get speedy US approval after all

6 July 2022

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.

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