Axsome Therapeutics, Inc. (NASDAQ:AXSM) 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 (NYSE:GSK) 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 (NYSE:AGN) with products like Vraylar and Viibryd, and Eli Lilly (NYSE:LLY) with Cymbalta and Zyprexa.
In March 2019, the FDA approved Johnson & Johnson’s (NYSE:JNJ) 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.
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
In addition to the stocks discussed above, would you like to know about our 10 finest buy-and-holds for the year?
Who wouldn't? Our annual Top 10s have beaten the market with amazing regularity. In 2018, while the market dropped -5.2%, the portfolio scored well into double-digits overall with individual stocks rising as high as +61.5%. And from 2012-2017, while the market boomed +126.3, Zacks' Top 10s reached an even more sensational +181.9%.
Allergan plc (AGN): Free Stock Analysis Report
Johnson & Johnson (JNJ): Free Stock Analysis Report
GlaxoSmithKline plc (GSK): Free Stock Analysis Report
Axsome Therapeutics, Inc. (AXSM): Free Stock Analysis Report
Original post
Zacks Investment Research