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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.
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July 31, 2014
07:14 EDTALKSAlkermes cuts FY14 adjusted EPS view to 19c-32c, consensus 49c
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07:12 EDTALKSAlkermes reports Q2 adjusted EPS 11c, consensus 14c
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July 30, 2014
07:17 EDTALKSAlkermes announces initiation of ALKS 5461 FORWARD-5 clinical study
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July 17, 2014
07:05 EDTALKSAlkermes announces initiation of Phase 1 study of ALKS 8700 for treatment of MS
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