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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.
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September 15, 2014
07:55 EDTALKSAlkermes shares attractive ahead of Q1 catalysts, says Leerink
Leerink says its recent meeting with Alkermes management confirmed its conviction that the company is executing on its growth strategy. Leerink believes clinical trials for ALKS 8700 in multiple sclerosis, ALKS 7106 in abuse deterrent opiate analgesic and the Phase II trial for ALKS 3831 in schizophrenia are all billion dollar market opportunities that are not reflected in the current stock price. The firm finds the stock attractively valued ahead of clinical data readouts that start in early Q1 of 2015. It reiterates an Outperform rating on Alkermes with a $66 price target.
September 9, 2014
06:51 EDTALKSAlkermes management to meet with Leerink
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