In the field of amyotrophic lateral sclerosis (ALS), also known as Lou Gehrig's disease, there aren't yet any approved treatments that address the disease itself. This will most likely change by the end of September. A panel of independent advisors to the Food and Drug Administration, meeting for the second time to discuss an experimental new ALS drug from Amylyx Pharmaceuticals (NASDAQ: AMLX), recently gave it a thumbs-up.

Does the potential approval of Amylyx's first drug make this biotech stock a smart buy right now? Let's weigh reasons to be bullish for Amylyx against reasons to remain cautious for now.

Amylyx is a pre-commercial biotech company in the U.S., and its lead candidate AMX0035 is currently in a phase 3 trial expected to read out top-line results late next year. Obviously, the company would like to start selling AMX0035 to ALS patients before phase 3 data is ready. It has a chance of earning accelerated approval based on the successful results of a phase 2 trial that wrapped up in 2020.

Continue reading

Source Fool.com