Amylyx fails to win FDA AdCom backing for ALS drug

Mar. 30, 2022 4:51 PM ETAmylyx Pharmaceuticals, Inc. (AMLX)RETABy: Dulan Lokuwithana, SA News Editor3 Comments

Headquarters of US Food and Drug Administration (FDA)

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  • An advisory committee of the U.S. Food and Drug Administration (FDA) on Wednesday voted against the approval of AMX0035, an investigational therapy for amyotrophic lateral sclerosis, developed by Amylyx Pharmaceuticals (NASDAQ:AMLX).
  • On the question of “do the data from single-trial & open-label study establish a conclusion that the drug is effective?” four panelists voted “Yes,” while six committee members voted “No”.
  • The FDA's advisory committees issue non-binding recommendations. However, the regulator usually follows them before a final decision on authorizations.
  • Currently, Amylyx (AMLX) shares are on hold for trading pending news.
  • Ahead of the AdCom meeting, Reata Pharmaceuticals (RETA), a developer focused on a neurological disease called Friedreich’s ataxia, joined Amylyx (AMLX) to decline as the investors reacted to briefing documents released by the FDA on AMX0035.

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