Axsome Shares Rally Premarket on Proposed AXS-05 Labeling

 Shares of Axsome Therapeutics Inc. jumped more than 30% in premarket trading Monday after the biopharmaceutical company reported a positive development in its efforts to secure U.S. Food and Drug Administration approval of AXS-05 for the treatment of major depressive disorder.

In a brief filing with the U.S. Securities and Exchange Commission, the New York company said it received proposed labeling for AXS-05 from the FDA.

Axsome said it is reviewing the proposed labeling and will reply to the FDA to secure final agreement.

The FDA had previously set an August 2021 target action date for the application, but Axsome last year said the agency had flagged deficiencies with the application that precluded the discussion of labeling and post-marketing requirements and commitments, raising fears the agency might reject the application.

While the FDA missed the target action date, its review of Axsome's application has continued, and Axsome in April said it had agreed to post-marketing requirements and commitments proposed by the agency, and that it expected the FDA could act on its application during the second quarter.

https://www.morningstar.com/news/dow-jones/202206273038/axsome-shares-rally-premarket-on-proposed-axs-05-labeling