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April 8, 2014
07:04 EDTALKSAlkermes announces phase 3 'positive' results from aripiprazole lauroxil study
Alkermes announced "positive" topline results from a randomized, double-blind, placebo-controlled phase 3 clinical trial of aripiprazole lauroxil in patients with schizophrenia. Patients treated once monthly with either 441 mg or 882 mg of aripiprazole lauroxil demonstrated statistically significant reductions from baseline in Positive and Negative Syndrome Scale total scores at week 12, compared to placebo, which was the prespecified primary endpoint in the study. Based on the positive results from this phase 3 study, Alkermes plans to submit a New Drug Application to the U.S. Food and Drug Administration in 3Q14. In addition to meeting the prespecified primary efficacy endpoint, the study also met the prespecified key secondary endpoint of improvement on the Clinical Global Impression-Improvement scale versus placebo at week 12. Aripiprazole lauroxil was generally well tolerated in the phase 3 study, and the 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. Alkermes will present data from the phase 3 study at an upcoming medical meeting and submit the results for publication in a peer-reviewed journal.
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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