Amylyx shares routed on skeptical adcomm docs — but did the FDA leave an open door on unmet ALS need?
The FDA released its briefing documents for Wednesday’s advisory committee to discuss Amylyx Pharmaceuticals’ ALS drug, and the initial impression appears to bode poorly for the biotech — at least on the data.
Agency statisticians called into question the company’s efficacy and survival analyses, raising the specter of a potential vote against the drug, known as AMX0035. In the briefing documents, released Monday morning, the FDA said data outlining the drug’s effectiveness were “not persuasive.”
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