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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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August 24, 2015
08:11 EDTALKSAlkermes delay for Aristada due to administrative issues, says Jefferies
Jefferies said it appears that the FDA's delay in approving Alkermes' Aristada is due to the agency's need for some additional review time. The firm said the fact that the FDA did not choose to issue a CRL letter gives it confidence that Alkermes should receive full approval in a "few weeks" and it maintains its Buy rating and $76 price target on the stock.
August 21, 2015
16:01 EDTALKSAlkermes provides update on FDA review of ARISTADA
Alkermes announced that the U.S. FDA has advised Alkermes that it will not be able to complete its review of the New Drug Application for ARISTADA for the treatment of schizophrenia by the Prescription Drug User Fee Act action date of Aug. 22, 2015. The FDA indicated that this delay was expected to be brief, measured in terms of weeks, but could not confirm specific timing. The FDA also indicated that no additional data or information is required from Alkermes at this time. "We are confident in the ARISTADA program and our NDA submission, and we will work closely with the FDA as they complete their review," said Elliot Ehrich, M.D., Chief Medical Officer of Alkermes. "We look forward to bringing ARISTADA to market as a potential new treatment option to help address the significant unmet medical needs of patients living with schizophrenia."

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