New ALS drug may have to wait until 2024 for approval

5 September 2022

The likelihood of approval for the amyotrophic lateral sclerosis (ALS) candidate AMX0035 appeared to fade on Friday, following the release of downbeat briefing papers from the US regulator.

Amylyx Pharmaceuticals (Nasdaq: AMLX) is developing the drug, a fixed-dose combination of sodium phenylbutyrate and taurursodiol, for the treatment of ALS and other neurodegenerative diseases.

The firm’s original plan was to seek a nod on the basis of mid-stage data, with an Accelerated Approval one option under consideration by the FDA.

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