According to an Axsome Therapeutics news release, the company’s trial of AXS-05 for major depressive disorder met its primary endpoint. This saw it bringing a significant reduction on the Montgomery-Åsberg Depression Rating Scale.
It wasn’t just the primary endpoints of the study that did well. The Axsome Therapeutics news release also notes that AXS-05 also turned in a significant improvement for its secondary endpoints as well when compared to placebo at six weeks.
Professor Maurizio Fava, MD, Psychiatrist-in-Chief at Massachusetts General Hospital, says this about the Axsome Therapeutics news.
“AXS-05 demonstrated a rapid and very clinically meaningful improvement in depressive symptoms, observed after only one week, in this large and well-controlled Phase 3 trial in major depressive disorder. Given the known challenges of conducting trials in psychiatry, it is very encouraging to see replication of Phase 2 findings in such a robust way.”
Axsome Therapeutics plans to push forward with the positive results from the Phase 3 Trial and submit a New Drug Application (NDA) to the U.S. Food and Drug Administration. It will do so during the second half of 2020.
Axsome Therapeutics also notes that it will be releasing more detailed results from the trial at a later time.
AXSM stock was up 75.72% as of Monday afternoon. The stock is also up 1645.90% since the start of the year.
As of this writing, William White did not hold a position in any of the aforementioned securities.