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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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November 18, 2015
07:43 EDTALKSJefferies to hold a conference
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November 16, 2015
08:12 EDTALKSLeerink reiterates Outperform rating, $84 target on Alkermes
After hosting a conference call with CEO Richard Pops and CFO Jim Frates, Leerink analyst Paul Matteis reiterates an Outperform rating on Alkermes with an $84 price target. The analyst continues to believe the '5461 FORWARD Phase 3 program for depression is "employing a robust, proven study design." The drug likely only needs to hit on two of three pivotal efficacy studies for FDA approval, Matteis reiterates to investors in a research note.
07:57 EDTALKSLeerink biotech analyst holds an analyst/industry conference call
Biotech Analyst Matteis, along with MEDACorp specialists Anthony Rothschild, M.D., Director of the University of Massachusetts Depression Center and Darin Dougherty, M.D., Harvard Medical School, discuss their views on Alkermes' ALKS-5461's probability-of-success in Phase III and the commercial potential of ALKS-5461 on an Analyst/Industry conference call to be held on November 16 at 2 pm.

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