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Axsome stock up 84% premarket as drug reduces depression in phase 3 trial

Axsome Therapeutics Inc. said AXS-05 improved symptoms of depression in patients, meeting the main goal of a late-stage clinical trial.

The New York-based biopharmaceutical company's stock was up by 84.04% to $86.11 in pre-market trading on Dec. 16.

Axsome's phase 3 trial called Gemini enrolled 327 adult patients with confirmed moderate to severe major depressive disorder. Patients received either AXS-05 or a placebo.

Major depressive disorder is a mood disorder that causes persistent feelings of sadness and loss of interest, which can lead to emotional and physical problems for patients. About 17 million people in the U.S. experience the disorder each year, Axsome said in a Dec. 16 press release.

After six weeks of treatment, patients on AXS-05 showed a reduction in depression severity, compared to those taking placebo. The therapy also demonstrated statistically significant improvements in all secondary goals of the study. The company said the drug was well-tolerated, and the most commonly reported adverse events were dizziness, nausea and headache, among other things.

Axsome CEO Herriot Tabuteau said the company expects to file for a U.S. approval of AXS-05 in the second half of 2020 based on the results from Gemini and a previous trial called Ascend. In January, the company reported results from the phase 2 Ascend trial, which showed that the medicine helped reduce depression symptoms in patients.

AXS-05 received the U.S. Food and Drug Administration's fast-track designation for treatment-resistant depression and breakthrough-therapy status to treat major depressive disorder. The drug is also being evaluated in another phase 3 trial known as Stride-1 to treat patients with major depressive disorder who failed one or two prior antidepressant therapies.

In addition, AXS-05 has been shown to help reduce daily smoking in adults in a phase 2 trial. The company said AXS-05 is also being evaluated in patients with Alzheimer's disease agitation in a study called Advance-1.