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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