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November 25, 2013
07:07 EDTOREXOrexigen announces successful interim analysis of contrave light study
Orexigen announced successful results of the interim analysis of the Light Study. Based on these results, the company will resubmit the Contrave New Drug Application to the FDA in the next few weeks with potential approval by June 2014. The FDA previously agreed that if the interim analysis meets the specified criteria to exclude cardiovascular risk, Contrave could be approved. The pre-specified criteria for the interim analysis is to exclude a hazard ratio of 2.0, using the upper bound of the 95% confidence interval, for excess risk of major adverse cardiovascular events in patients receiving Contrave as compared to placebo. In addition to meeting the pre-specified criteria for excluding cardiovascular risk, no new safety signals were observed.
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April 8, 2014
11:03 EDTOREXPiper Jaffray's biopharm analyst holds an analyst/industry conference call
Biopharm Analyst Schimmer discusses PCSK9 Inhibitors and other atherosclerosis approaches on an Analyst/Industry conference call. Relevant companies AEGR, ALNY, AMGN, ARNA, AZN, BMY, CBST, LLY, ESPR, GSK, ICPT, ISIS, MNKD, MRK, OREX, PFE, REGN, RHHBY, SNY and VVUS may be included on the Analyst/Industry conference call to be held on April 10 at 3 pm.

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