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predicting the 7 stocks that will soar highest in the coming month.
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Axsome's Depression Drug Gets Breakthrough Therapy Status
Axsome Therapeutics, Inc. (AXSM - Free Report) announced that the FDA has granted Breakthrough Therapy designation to AXS-05 for the treatment of major depressive disorder (MDD). The candidate is a novel, oral, investigational NMDA receptor antagonist with multimodal activity.
The Breakthrough Therapy designation is granted to speed up the development and review of drugs that target serious or life-threatening conditions.
Shares of the company have soared 521.7% in the past year against the industry’s decline of 13.7%.
The designation was supported by positive results from the phase II ASCEND study, in which 80 patients with confirmed moderate to severe MDD were treated with AXS-05 or GlaxoSmithKline’s (GSK - Free Report) active comparator, Wellbutrin (bupropion). The study showed that treatment with AXS-05 resulted in substantial, rapid and statistically significant reduction in depressive symptoms as compared to bupropion.
MDD affects about 6.7% of adults in the United States and is a chronic, biologically-based disorder that can result in suicide.
The depression market is quite large and has many players, including biggies like Allergan with products like Vraylar and Viibryd, and Eli Lilly with Cymbalta and Zyprexa.
In March 2019, the FDA approved Johnson & Johnson’s (JNJ - Free Report) nasal spray, Spravato (esketamine) for treatment-resistant depression (TRD) in adults, but with a boxed warning. The nasal spray has been approved for use in conjunction with an oral antidepressant in patients with MDD who have not benefited from multiple standard treatments.
Axsome Therapeutics, Inc. Price
Axsome Therapeutics, Inc. Price | Axsome Therapeutics, Inc. Quote
Zacks Rank
Axsome currently carries a Zacks Rank #4 (Sell).You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.
Zacks' Top 10 Stocks for 2019
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