- 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.