Amylyx readies for make-or-break PhIII, looking to address uncertainty over controversial ALS drug

About a decade ago, David Buseck’s left foot first start­ed drag­ging dur­ing a race. He chalked it up to not be­ing much of a run­ner. In hind­sight, he sees it as his first warn­ing sign of ALS, the dis­ease that’s slow­ly but sure­ly at­tack­ing his en­tire body.

Buseck, a 61-year-old Bay Area res­i­dent, is one of thou­sands now plac­ing un­cer­tain hope in a new drug, which gained a con­tro­ver­sial FDA ap­proval in 2022 af­ter a rocky and un­usu­al reg­u­la­to­ry jour­ney. Now, the drug’s fu­ture — and whether pa­tients like Buseck can or will keep tak­ing it — could hinge on a late-stage study that will be an­nounced be­tween now and the end of June.

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