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Axsome's (AXSM) AXS-05 Fails to Meet Main Goal in TRD Study

Axsome Therapeutics, Inc. AXSM announced mixed top-line data from the phase III STRIDE-1 study evaluating its pipeline candidate AXS-05 to address patients with treatment resistant depression (TRD).

The primary endpoint following the week six of treatment did not reach any statistical significance in the above-mentioned study.

Nevertheless, the candidate met key secondary endpoints by demonstrating rapid and statistically significant improvements in depressive symptoms, per the Montgomery-Åsberg Depression Rating Scale (MADRS) measure at week one and for the overall six-week treatment period compared to the active comparator bupropion in the given patient population.

This randomized, double-blind, active-controlled study is assessing the safety and efficacy of AXS-05 for the aforementioned patient population. Based on results from the STRIDE-1 study, Axsome plans to initiate a second phase III study on AXS-05 in the third quarter of 2020 for addressing patients with TRD.

Shares of Axsome have skyrocketed 326.2% in the past year against the industry’s decline of 11.8%.

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 treating major depressive disorder (MDD) as well as a phase II/III ADVANCE-1 study on agitation associated with Alzheimer's disease (AD).

Per the company, positive outcomes from GEMINI study on MDD along with the 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 fourth quarter of 2020.

In March 2020, Axsome announced that it is accelerating the completion time of the phase II/III ADVANCE-1 study on AXS-05. As a result, top-line findings from the study are now expected in early second-quarter 2020, which were previously awaited in the third. The study is currently enrolling patients aged 65 years and above.

Zacks Rank & Stocks to Consider

Axsome currently carries a Zacks Rank #3 (Hold). Better-ranked stocks in the biotech sector include Acorda Therapeutics, Inc. ACOR, Regeneron Pharmaceuticals, Inc. REGN and Trevena, Inc. TRVN, all sporting a Zacks Rank #1 (Strong Buy). You can see the complete list of today’s Zacks #1 Rank stocks here.

Acorda’s loss per share estimates have narrowed 8.8% for 2020 over the past 60 days.

Regeneron’s earnings estimates have been revised 6% upward for 2020 over the past 60 days. The stock has rallied 14.3% in the past year.

Trevena’s loss per share estimates have narrowed 26.4% for 2020 over the past 60 days.

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Regeneron Pharmaceuticals, Inc. (REGN): Free Stock Analysis Report
Acorda Therapeutics, Inc. (ACOR): Free Stock Analysis Report
Axsome Therapeutics, Inc. (AXSM): Free Stock Analysis Report
Trevena, Inc. (TRVN): Free Stock Analysis Report
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