Shares of Axsome Therapeutics Inc. (NASDAQ: AXSM) are more than doubling after positive trial results for the experimental drug, AXS-05. The result prompted the company’s stock to rise up to 160% in pre-market trading on Monday.
Axsome Therapeutics is a clinical-stage biopharmaceutical company developing novel therapies for the management of central nervous system (CNS) disorders. On Monday the Company announced that one of there experimental drugs that treats depression, AXS-05, met the prespecified primary endpoint and significantly improved symptoms of depression in the ASCEND Phase 2 trial in major depressive disorder (MDD).
After six weeks of the trial, the experimental drug was able to significantly improve symptoms of depression when compared to bupropion.
AXS-05 rapidly reduced depressive symptoms over those six weeks, demonstrating a statistically significant improvement over bupropion on the Clinical Global Impression-Improvement scale (CGI-I) at Week 1 (p=0.045). Starting at Week 1, AXS-05 achieved numerical superiority over bupropion on the MADRS total score, with statistical significance achieved at Week 2 and maintained at all time points thereafter.
At Week 6, 47% of patients who received AXS-05 achieved remission, prospectively defined as a score of 10 or less on the MADRS, compared with 16% of patients who received bupropion (p=0.004).
After the announcement of the positive results, Axsome shares rose more than 160% in pre-market trading to USD 7.00 per share. This only comes as the second, sizable gain for the stock in a week. Axsome shares climbed 29% last Monday resulting from management release of a year-end clinical update for its drug portfolio. Axsome had a market value of USD 78.4 Million as of Friday’s close.
The experimental drug is making strides in treating depression and has now been granted fast-track status by the FDA. The drug is also being tested a treatment for agitation associated with Alzheimer’s and smoking cessation.
Professor Maurizio Fava, MD, Executive Vice Chair, Department of Psychiatry, Massachusetts General Hospital (MGH) and Associate Dean for Clinical & Translational Research, Harvard Medical School said, "Data show currently marketed antidepressants fail to provide adequate treatment response in about two-thirds of treated patients. An estimated 16 million Americans suffer from major depressive disorder each year. As an oral NMDA receptor antagonist with multimodal activity, AXS-05 could provide a new approach to treating this potentially life-threatening condition."