ARTICLE | Clinical News

Orexigen off after reporting SAE

May 9, 2008 11:56 PM UTC

Orexigen (NASDAQ:OREX) fell $0.84 to $9.14 on Friday after reporting late Thursday the occurrence of a single serious adverse event (SAE) in a double-blind Phase IIb trial of Empatic to treat obesity. The company said that of the four women who became pregnant during the study, all carried to term but one of the infants had a heart-related birth abnormality that was corrected surgically. The abnormality was characterized as an SAE possibly related to Empatic. In July 2007, Orexigen said all six doses of Empatic met the primary endpoint of a significant reduction in weight from baseline to week 24 vs. placebo (p<0.001) (See BioCentury Extra, Tuesday, July 24, 2007). ...