The Latest Breaking News from Amylyx Pharmaceuticals

Amylyx Pharmaceuticals withdraws Relyvrio drug for ALS due to lack of efficacy, leading to layoffs and disappointment in ALS community.

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Biotech stocks are scorching right now. But the best of the best have strong gains. Those include 10 with at least 40% growth this year.

IPO stock Amylyx Pharmaceuticals jumped Monday as the Food and Drug Administration prepares to review its controversial ALS treatment again.

The U.S. Food and Drug Administration (FDA) has extended the review of New Drug Application (NDA) by three months, submitted by Amylyx Pharmaceuticals  (NASDAQ: AMLX) for its lead drug candidate AMX0035 with regard to the treatment of patients with amyotrophic lateral sclerosis (ALS).

The FDA pushed its review date for Amylyx Pharmaceuticals' controversial ALS treatment on Friday, and the biotech stock skyrocketed.

Amylyx Pharmaceuticals Inc (NASDAQ: AMLX) shares are trading higher by 37.67% at $13.45 after the company announced the FDA extended the review timeline of the New Drug Application for AMX0035.

Within the last quarter, Amylyx Pharmaceuticals (NASDAQ:AMLX) has observed the following analyst ratings:

A panel of the Food and Drug Administration’s expert advisers on Wednesday voted 6 to 4 against approving Amylyx Pharmaceuticals’ treatment for ALS. The FDA now has until June 29 to decide whether to follow the panel’s advice or let the closely watched drug on to the market.