- Amylyx Pharmaceutical ( NASDAQ: AMLX ) is trading 81% higher premarket after a panel of experts to the U.S. Food and Drug Administration voted in favor to recommend approval of the drug, AMX0035, to treat neurodegenerative disease amyotrophic lateral sclerosis (ALS).
- If gains hold, the stock is set to reverse its YTD losses.
- In a rare second meeting, the FDA's panel voted 7 in favor and 2 against for the drug.
- The advisory committee's nod comes after the panel in March rejected the drug due to issues with trial data.
- The FDA often follows the advisory committee's recommendations, though it is not obligated to.
- A decision by the FDA is expected by Sept. 29.
- Shares of Reata Pharmaceuticals ( RETA ) and Ardelyx ( ARDX ), fellow clinical-stage biopharma companies that face their own upcoming AdCom meetings, are up ~10% and 2.5% higher , respectively.
- Citi research analyst Neena Bitritto-Garg thinks the approval is now "very highly likely", particularly due to the political pressure to approve new therapies for ALS, raises price target to $48 from $35.
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Amylyx Pharma stock surges 81% after ALS drug gets FDA advisers backing