Amylyx Pharmaceuticals (NASDAQ: AMLX) is up more than 100% over the past three months. The stock surged again on Sept. 7 after a Food and Drug Administration (FDA) advisory panel changed their minds to say they now think that Albrioza (sodium phenylbutyrate and taurursodiol), should be approved as a treatment for amyotrophic lateral sclerosis (ALS). Trading of Amylyx stock was briefly halted on the NASDAQ pending the panel's decision.

The same panel that voted 6-4 against approving Albrioza (AMX0035) back in March this week voted 7-2 to recommend its approval after looking at new data and analyses from its phase 2 clinical trial. A phase 3 trial for the drug is underway, and is expected to end in March 2024.

Getting a thumbs up from the advisory committee is a big step, but it's not the final step. The FDA still must decide whether or not to approve Albrioza.

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Source Fool.com