New User:

Forgot your password?

Stock Market & Financial Investment News

News Breaks
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
Sign up for a free trial to see the rest of the stories you've been missing.
November 18, 2015
07:43 EDTALKSJefferies to hold a conference
Subscribe for More Information
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.

Sign up for a free trial to see the rest of the stories you've been missing.
I agree to the disclaimer & terms of use