BioCentury
ARTICLE | Company News

Orexigen falls following FDA comments

March 7, 2015 2:23 AM UTC

Orexigen Therapeutics Inc. (NASDAQ:OREX) fell $0.91 (11%) to $7.10 on Friday after media reports said John Jenkins, director of FDA's office of new drugs, said the company could face penalties as a result of its premature disclosure of data from the LIGHT cardiovascular outcomes trial of obesity drug Contrave naltrexone/ bupropion.

The interim data, disclosed Tuesday in a patent and a subsequent regulatory filing, were part of Orexigen's December 2013 NDA resubmission for Contrave. Last year, the agency voiced concern that Orexigen had disclosed the interim analysis to too many people, potentially biasing the trial. FDA required a second CV outcomes trial when it approved Contrave last September (see BioCentury, Sept. 22, 2014). ...