Monday, January 24, 2011

Clinical Data, Inc. (NASDAQ: CLDA) Wins FDA Approval for Vilazodone to Treat Depression

Shares of Clinical Data, Inc. (NASDAQ:CLDA) climbed 56.29% and is currently trading at $23.49 after the FDA approved Clinical Data’s NDA submission for vilazodone. A Boston-based Biotech Company climbed to its new annual high of $25.35 in today's trading session, its annual low being $10.87. The stock traded with volume of 7.79 million shares compared to the daily average volume of 357,590 shares. Currently, the market capitalization of the stock stands at $703.95 million with beta of 1.61. On January 21, 2011, the FDA approved CLDA's vilazodone, a new antidepressant, as a first line therapy for major depressive disorder (MDD). The Company plans to market the new antidepressant under the brand name Viibryd. Viibryd (vilazodone), a novel, dual-acting serotonergic antidepressant, is a potent and selective serotonin reuptake inhibitor, or SSRI, first line therapy for major depressive disorder (MDD), and partial agonist of the 5-hydroxytryptamine 1a, or 5-HT1A, receptor. This approval is based on the results of two positive Phase 3 studies showing a significant improvement in primary endpoint of change in Montgomery Asberg Depression Rating Scale total score at eight weeks. In addition, the Phase 3 studies also showed significant improvements in the Hamilton Depression Rating Scale (HAM-D-17), the Hamilton Rating Scale for Anxiety (HAM-A), and the Clinical Global Impressions Severity of Illness and Improvement (CGIS and CGI-I), underscoring the activity of the compound. The drug will be available in 10mg, 20mg and 40mg tablets and like all antidepressants; this will also carry a black box warning for suicidality in children and young adults. This drug has no effect on sexual function, a common side effect of many leading antidepressants. A lack of weight gain and potential fast onset are additional advantages. Clinical Data, Inc. is focused on the development and commercialization of therapeutics, with two compounds in the areas of central nervous system and cardiovascular disorders. Disclaimer: The assembled information distributed by epicstockpicks.com is for information purposes only, and is neither a solicitation to buy nor an offer to sell securities. Epicstockpicks.com does expect that investors will buy and sell securities based on information assembled and presented herein. EpicStockPicks.com will not be responsible in any way for or accept any liability for any losses arising from an investor's reliance on or use of information obtained from our website or emails. PLEASE always do your own due diligence, and consult your financial advisor.
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