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June 18, 2014
07:03 EDTALKSAlkermes presents aripiprazole lauroxil phase 3 data
Alkermes announced the presentation of data from its phase 3 clinical trial of aripiprazole lauroxil at the American Society of Clinical Psychopharmacology Annual Meeting. In the pivotal study, both doses of aripiprazole lauroxil tested, 441 mg and 882 mg administered once-monthly, met the primary endpoint with statistically and clinically significant reductions in Positive and Negative Syndrome Scale scores, met all secondary endpoints and demonstrated significant improvements in schizophrenia symptoms versus placebo. This is the first demonstration of the efficacy of a range of doses of a long-acting injectable form of aripiprazole in a randomized clinical trial. The company remains on track to submit a New Drug Application to the U.S. Food and Drug Administration in 3Q14. Aripiprazole lauroxil was generally well tolerated in the study, and the observed 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.
News For ALKS From The Last 14 Days
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September 1, 2015
10:04 EDTALKSOn The Fly: Analyst Upgrade Summary
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09:25 EDTALKSOn The Fly: Pre-market Movers
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07:11 EDTALKSMorgan Stanley ups Alkermes two notches with $85 price target
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06:46 EDTALKSAlkermes upgraded to Overweight from Underweight at Morgan Stanley
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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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