Axsome Therapeutics (AXSM) Stock Soars on FDA Labeling Proposal


  • Axsome Therapeutics (AXSM) stock is gaining on an update from the U.S. Food and Drug Administration (FDA).
  • This covers the proposed labeling for a major depressive disorder drug.
  • AXSM intends to reply to the FDA for final product labeling.
AXSM Stock - Axsome Therapeutics (AXSM) Stock Soars on FDA Labeling Proposal

Source: Pavel Kapysh/

Axsome Therapeutics (NASDAQ:AXSM) stock is rising higher on Monday following an update from the U.S. Food and Drug Administration (FDA) about product labeling.

This update was announced in a filing with the U.S. Securities and Exchange Commission (SEC). In that filing, Axsome Therapeutics said it has received proposed labeling for its AXS-05 product candidate.

AXS-05 is a product in development by the biopharmaceutical company with a New Drug Application (NDA) already submitted. The purpose of the drug is to treat patients suffering from major depressive disorder.

Axsome Therapeutics notes that it’s reviewing the proposed label from the FDA. After that’s complete, it will reply to the organization to obtain the final labeling for the major depression disorder drug.

News of the proposed labeling from the FDA has shares of AXSM stock seeing heavy trading on Monday. As of Monday morning, more than 7 million shares of AXSM stock have changed hands. That’s a massive increase over its daily average trading volume of 1.1 million shares!

With that heavy trading comes a rally that has shares of AXSM stock up 41.5% as of Monday morning. However, shares of AXSM stock are still down 8% since the start of the year.

Investors on the lookout for more recent stock market coverage are in the right place!

We’ve got all the hottest stock market news that traders need to know about for Monday! A few examples include what has shares of Epizyme (NASDAQ:EPZM) stock rising higher today, this morning’s biggest pre-market stock movers, as well as the latest news on Tesla (NASDAQ:TSLA) stock. You can learn all about these matters at the links below!

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On the date of publication, William White 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.

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