Axsome's AXS-05 meets in Phase II for MDD

Axsome Therapeutics Inc. (NASDAQ:AXSM) added $4.24 (161%) to $6.87 on Jan. 7 after reporting that AXS-05 met the primary endpoint in the Phase II ASCEND trial to treat moderate-to-severe major depressive disorder (MDD).

On the primary endpoint, twice-daily AXS-05 significantly reduced mean Montgomery-Asberg Depression Rating Scale (MADRS) total score from baseline to an average over the six-week treatment period vs. bupropion (13.7 vs. 8.8 points, p<0.001). AXS-05 also met the secondary endpoints of improving Clinical Global Impression-Severity scale (CGI-S) score (p=0.028) and of a greater proportion of patients who achieved remission (47% vs. 16%, p=0.004) at week six vs. bupropion. The double-blind, U.S. trial enrolled 80 patients...