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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 - Free Report) and Inovio Pharmaceuticals, Inc. 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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