Axsome Therapeutics, Inc. AXSM announced that it has completed patient randomization in the phase III STRIDE-1 (Symptom Treatment in Resistant Depression 1) study evaluating its pipeline candidate AXS-05 to address patients with treatment resistant depression (TRD).
The randomized, double-blind, active-controlled study is assessing the safety and efficacy of AXS-05 for the above-mentioned patient population. The primary endpoint of the study is to see the change in the Montgomery-Åsberg Depression Rating Scale (MADRS) following six weeks of treatment.
Top-line data from the STRIDE-1 study is expected to be announced in the first quarter of 2020.
Shares of Axsome have skyrocketed 949.3% in the past year versus the industry’s decrease of 2.1%.
AXS-05 is a novel, oral, investigational non-competitive N-methyl-D-aspartate (NMDA) receptor antagonist with multimodal activity under development for treating central nervous system (CNS) disorder. Apart from the STRIDE-1 study, Axsome is conducting a phase III GEMINI study on AXS-05 for the treatment of major depressive disorder (MDD) and a phase II/III ADVANCE-1 study on agitation associated with Alzheimer's disease (AD). The company completed a phase II ASCEND study on MDD and a phase II study on smoking cessation.
Notably, in December 2019, AXS-05 met the primary endpoint and significantly improved symptoms of depression in the phase III GEMINI study in MDD. The candidate met the primary endpoint by demonstrating a highly statistically significant reduction in the MADRS total score compared to placebo at week six of treatment.
Per the company, positive results from the GEMINI study on MDD along with its previously completed ASCEND study, will be sufficient to support the filing of a new drug application (NDA) for AXS-05 to treat MDD. The NDA is expected to be filed in the second half of 2020.
Axsome’s portfolio is currently devoid of any approved product. Hence, the successful development and commercialization of the candidate will be a significant boost to this clinical-stage biopharmaceutical company.
In March 2019, the FDA granted Breakthrough Therapy designation to AXS-05 for the treatment of MDD. The candidate is also given a Fast Track tag by the regulatory agency to address TRD.
Zacks Rank & Stocks to Consider
Axsome currently carries a Zacks Rank #3 (Hold). Better-ranked stocks in the biotech sector include PDL BioPharma, Inc. PDLI, Denali Therapeutics Inc. DNLI and Epizyme, Inc. EPZM, all sporting a Zacks Rank #1 (Strong Buy). You can see the complete list of today’s Zacks #1 Rank stocks here.
PDL BioPharma’s earnings estimates have been revised 37.5% upward for 2020 over the past 60 days. The stock has inched up 4.6% in the past year.
Denali’s loss per share estimates have narrowed 0.4% for 2020 over the past 60 days. The stock has risen 9.2% in the past year.
Epizyme’s loss per share estimates have narrowed 2.5% for 2020 over the past 60 days. The stock has skyrocketed 179.7% in the past year.
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