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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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October 30, 2014
08:14 EDTALKSAlkermes proprietary programs remain on track, says Leerink
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08:09 EDTALKSAlkermes pipeline value set to come into focus, says FBR Capital
FBR Capital says investor sentiment toward Alkermes will "meaningfully shift" over the next 18 months as results from key trials become available. With an FDA action date of August 22, 2015, FBR believes the commercial potential of aripiprazole lauroxil may not be known until 2016. It thinks the 2016 results from the Phase III program of ALKS 5461, a potential treatment for major depressive disorder, may be more important. It sees the company's pipeline value coming into focus over the next six to 18 months and keeps a Market Perform rating on Alkermes following the company's Q3 results.
October 29, 2014
07:13 EDTALKSAlkermes reports Q3 AMPYRA, FAMPYRA revenues $16.5M
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07:11 EDTALKSAlkermes says entering Q4 with 'strong momentum'
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07:09 EDTALKSAlkermes sees FY14 free cash flow $20M
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07:05 EDTALKSAlkermes sees FY14 EPS 19c-32c consensus 27c
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07:04 EDTALKSAlkermes reports Q3 EPS 3c, consensus 2c
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October 23, 2014
06:51 EDTALKSAlkermes concerns removed with FDA acceptance, says Citigroup
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October 22, 2014
07:02 EDTALKSAlkermes aripiprazole lauroxil NDA accepted for filing by FDA
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October 21, 2014
07:54 EDTALKSLeerink a buyer of Alkermes, ImmunoGen, Incyte
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