No Rest Yet for Neurocrine

Neurocrine Biosciences(NBIX Quote) said Thursday it might need to conduct more clinical or pre-clinical trials on safety issues to secure approval of its insomnia drug Indiplon.

The company said a delay in getting U.S. regulatory approval probably will cause it to amend its financial guidance during its second-quarter Webcast, although Neurocrine provided no details.

The San Diego, Calif.-based company provided the update after markets had closed, saying it had prepared a response to questions that the Food and Drug Administration posed last month. On May 15, the agency granted conditional approval for a quick-release version of Indiplon, but the agency rejected an application for an extended-release version. ...