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News Breaks
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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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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