AMLX Stock Alert: Amylyx Pharma Gains on Huge FDA Win


  • Shares of Amylyx Pharma (AMLX) stock are up as much as 10% today on news the FDA has approved its treatment for ALS.
  • The approval is the first new time in fives years that the FDA has greenlit a new treatment for ALS.
  • Amylyx Pharma’s treatment has been found to extend the lives of people with ALS by 10 months.
AMLX stock - AMLX Stock Alert: Amylyx Pharma Gains on Huge FDA Win

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Shares of Amylyx Pharmaceuticals (NASDAQ:AMLX) stock were up as much as 10% in premarket trading today on news that the U.S. Food and Drug Administration (FDA) has approved its treatment of the deadly disease amyotrophic lateral sclerosis (ALS).

The approval marks the first time the FDA has greenlit a new ALS treatment in five years and represents a breakthrough for Amylyx Pharma. Prior to today, AMLX stock had risen 67% this year to trade at $30.19 per share. The stock has increased in recent months due to investor anticipation of the FDA’s approval of the company’s ALS treatment.

What Happened With AMLX Stock Today?

Amylyx Pharma has developed a drug that has been proven to slow the progression of the disease amyotrophic lateral sclerosis, commonly known as ALS, and delay death.

With the FDA approval, Amylyx Pharma said it now plans to move quickly to make the ALS medication publicly available under the brand name “Relyvrio,” and that doctors will be able to write prescriptions for the drug by year’s end.

“We know people living with ALS have no time to wait and, for this reason, Amylyx is prepared to move quickly with commercialization in the U.S.,” the company said in a news release.

Why It Matters

ALS, which is also associated with former professional baseball payer Lou Gehrig, breaks down nerve cells in the brain and spinal cord and prevents muscles from working properly. Eventually, ALS leads to paralysis and death. Other notable people with ALS include British physicist Stephen Hawking, who was confined to a wheelchair for most of his adult life.

The ALS Association says that the diseases impacts 30,000 people in the U.S., with 5,000 new cases diagnosed each year. ALS is most common in people over age 60. Globally, more than 200,000 people are living with ALS. The average life expectancy of someone who has the disease is two to five years. Amylyx Pharma’s treatment has been found to extend ALS patients’ life expectancy by as much as 10 months.

For Amylyx Pharma, commercialization of the ALS drug should bolster its revenue and profits going forward. Investment bank Goldman Sachs (NYSE:GS) has forecast annual sales for Relyvrio of $767 million in 2026.

What’s Next

This is an exciting day for Amylyx Pharma and investors who hold AMLX stock. It’s also a big day for ALS patients and their loved ones. The FDA approval gives hope to people and families who are struggling with the debilitating disease. Furthermore, it should ensure that Amylyx Pharmaceuticals continues researching other medical breakthroughs.

On the date of publication, Joel Baglole did not have (either directly or indirectly) any positions in the securities mentioned in this article. The opinions expressed in this article are those of the writer, subject to the Publishing Guidelines.

Joel Baglole has been a business journalist for 20 years. He spent five years as a staff reporter at The Wall Street Journal, and has also written for The Washington Post and Toronto Star newspapers, as well as financial websites such as The Motley Fool and Investopedia.

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