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Axsome Expedites Completion Timeline of AD Study on AXS-05

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Axsome Therapeutics, Inc. (AXSM - Free Report) announced that it is accelerating the completion time of the phase II/III ADVANCE-1 study, which currently evaluates AXS-05 for the treatment of agitation associated with Alzheimer's disease (AD). As a result, top-line data from the study is now expected in early second-quarter 2020, which was previously expected in the third.

The randomized, double-blind ADVANCE-1 study is currently enrolling patients who are aged 65 years and above. The company is looking to ensure the safety of the given patient population amid the COVID-19 pandemic as they stand at highest risk for COVID-19-related fatalities. Per the company, the AXS-05 arm along with the placebo arms is fully enrolled and more than 90% of patients is estimated to have completed the study.

Shares of Axsome have skyrocketed 233% in the past year against the industry’s decline of 16.3%.

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 ADVANCE-1 study, Axsome is conducting a phase III GEMINI study on AXS-05 for treating major depressive disorder (MDD) and the phase III STRIDE-1 study to address patients with treatment-resistant depression (TRD).

Per the company, positive results from its 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.

Notably, the World Health Organization recently declared the COVID-19 outbreak a pandemic, given the alarming levels of its spread and severity. With global coronavirus outbreak persistently posing a threat to human health, speedy development of vaccines is the need of the hour.

We note that efforts to develop a vaccine for combating the deadly novel coronavirus accelerated in the last couple of weeks.  Last week, Moderna, Inc., (MRNA - Free Report) dosed the first participant in the phase I study of mRNA vaccine (mRNA-1273) against SARS-CoV-2. Quite a few others like Novavax, Inc. NVAX and Inovio Pharmaceuticals, Inc. INO too are following suit.

We remain upbeat about the developments as several companies along with global authorities are working closely to innovate a treatment as early as possible to eradicate this deadly virus.

Zacks Rank

Axsome currently carries a Zacks Rank #3 (Hold). You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.

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