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Why Amylyx Pharmaceuticals Stock Is Bolting Higher Today


Amylyx Pharmaceuticals (NASDAQ: AMLX), a clinical-stage biopharma, is off to a good start this week. Shares of the small-cap biotech are up by a healthy 12%, on above-average volume, as of 11:54 a.m. ET Tuesday morning. 

What's sparking this double-digit rally? Amylyx's shares are responding positively to the news that the Food and Drug Administration (FDA) has decided to reconvene a panel of experts to discuss the pros and cons of the experimental amyotrophic lateral sclerosis (ALS) drug AMX0035. 

Earlier this year, this expert panel voted six to four against approving AMX0035 as a treatment for ALS. The company said that additional analyses on the drug's clinical trial data had led to a major amendment regarding this filing, prompting the FDA to take a second look. The agency is now slated to make a final decision on AMX0035 by Sept. 29, 2022. The drug's target action date was previously scheduled for June 29, 2022. 

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Source Fool.com

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