Amylyx Pharmaceuticals (NASDAQ:AMLX) stock is rocketing higher on Thursday following an update from the U.S. Food and Drug Administration (FDA) on its ALS treatment.
A letter from the FDA reveals that it now supports AMX0035 for the treatment of amyotrophic lateral sclerosis (ALS). This saw seven members of the FDA’s Peripheral and Central Nervous System Drugs Advisory Committee vote in support of the drug. Only two members voted against it.
The voting from the Peripheral and Central Nervous System Drugs Advisory Committee doesn’t mean that the FDA will approve AMX0035. However, the agency often follows the guidance of its advisors when reviewing New Durg Applications (NDAs).
According to Amylyx, the Prescription Drug User Fee Act target action date for its AMX0035 NDA is Sept. 29. That’s an extension to a previous date, as the FDA needed more time to review the NDA.
Amylyx Head of Scientific Communications Jamie Timmons said the following regarding the update:
“The Committee’s thoughtful review of the data and support of the benefit that AMX0035 may bring to the ALS community, if approved, is promising […] The CENTAUR trial data has consistently demonstrated potential benefits of AMX0035 on function and overall survival.”
AMLX stock is seeing heavy trading today on the FDA news. This has more than 3 million shares on the move as of this writing. That’s well above the company’s daily average trading volume of about 873,000 shares.
AMLX stock is up 70% as of Thursday morning.
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On the date of publication, William White did not hold (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 InvestorPlace.com Publishing Guidelines.
