Thinly traded nano cap Axsome Therapeutics (NASDAQ:AXSM) is up 46% premarket on light volume in response to its announcement of positive results from a Phase 2 clinical trial, ASCEND, evaluating Fast Track-tagged AXS-05 in patients with major depressive disorder (MDD).
The study met the primary endpoint of a statistically significant improvement in depression symptoms as measured by a scale called MADRS compared to bupropion. Specifically, at week 6, patients receiving AXS05, an NMDA receptor antagonist, demonstrated a 17.2-point reduction in MADRS total score versus a 12.1-point reduction for bupropion (p=0.013). At week 6, 47% of patients in the AXS-05 cohort achieved remission compared to 16% for bupropion (p-0.004).
Complete data will be submitted for presentation at future medical conferences.
A Phase 3 study, STRIDE-1, is in process.
Management hosted a conference call this morning at 8:30 am ET to discuss the results.
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