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June 18, 2014
07:03 EDTALKSAlkermes presents aripiprazole lauroxil phase 3 data
Alkermes announced the presentation of data from its phase 3 clinical trial of aripiprazole lauroxil at the American Society of Clinical Psychopharmacology Annual Meeting. In the pivotal study, both doses of aripiprazole lauroxil tested, 441 mg and 882 mg administered once-monthly, met the primary endpoint with statistically and clinically significant reductions in Positive and Negative Syndrome Scale scores, met all secondary endpoints and demonstrated significant improvements in schizophrenia symptoms versus placebo. This is the first demonstration of the efficacy of a range of doses of a long-acting injectable form of aripiprazole in a randomized clinical trial. The company remains on track to submit a New Drug Application to the U.S. Food and Drug Administration in 3Q14. Aripiprazole lauroxil was generally well tolerated in the study, and the observed safety profile of aripiprazole lauroxil was similar to that reported with oral aripiprazole. The most common adverse events in the study were insomnia, akathisia and headache.
News For ALKS From The Last 14 Days
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May 29, 2015
07:02 EDTALKSAlkermes plans to advance ALKS 8700 with twice-daily dosing in 2015
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May 21, 2015
09:58 EDTALKSOn The Fly: Analyst Initiation Summary
Today's noteworthy initiations include: Alibaba (BABA) initiated with an Outperform at Bernstein... Alkermes (ALKS) initiated with an Overweight at Barclays... Burlington Stores (BURL) initiated with an Outperform at FBR Capital... Crocs (CROX) initiated with a Neutral at B. Riley... Darling (DAR) initiated with a Buy at Roth Capital... Dynegy (DYN) initiated with an Outperform at RBC Capital... Esperion (ESPR) initiated with an Overweight at Barclays... Five Below (FIVE) initiated with a Market Perform at FBR Capital... Intercept (ICPT) initiated with an Overweight, $450 target at Barclays... Johnson Matthey (JMPLY) initiated with a Buy at Jefferies... Nike (NKE) initiated with a Buy at Jefferies... RTI Surgical (RTIX) initiated with a Buy at Sidoti... TeleNav (TNAV) initiated with an Outperform at Northland... Trevena (TRVN) initiated with an Equal Weight at Barclays... Vectrus (VEC) initiated with a Hold at Stifel.
05:37 EDTALKSAlkermes initiated with an Overweight at Barclays
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