Shares of Amylyx Pharmaceuticals (NASDAQ: AMLX) , a clinical-stage biopharmaceutical company, are tanking in response to comments from the FDA regarding the company's lead candidate. The stock was down 53.7% at 11:49 a.m. ET on Monday.
Amylyx has one new drug candidate in clinical-stage trials, a combination of sodium phenylbutyrate and taurusodiol tentatively named AMX0035. At the FDA's suggestion last year, the company submitted an application for AMX0035 that could make it a new treatment option for patients with amyotrophic lateral sclerosis (ALS).
ALS is a progressive neurodegenerative disorder that lacks treatment options. While some patients can survive more than a decade, the vast majority lose function in their limbs and then the ability to draw breath within a few years of their diagnosis.
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Here's Why Amylyx Pharmaceuticals Stock Is Getting Hammered on Monday