Orexigen Therapeutics Inc fka OREX

[$$$eeker]

Orexigen Receives Three Month Extension of FDA NB32 Review

SAN DIEGO, June 11, 2014 /PRNewswire/ -- Orexigen® Therapeutics, Inc. (OREX) today announced that the United States Food and Drug Administration (FDA) has extended its review of the resubmitted New Drug Application (NDA) for NB32, the Company's investigational medication being evaluated for weight loss. The new Prescription Drug User Fee Act (PDUFA) action date has been set for September 11, 2014.

The FDA has indicated that the review extension is needed to reach agreement on the post-marketing obligation related to the previously agreed upon evaluation of cardiovascular (CV) outcomes for NB32. The NDA resubmission package includes interim safety and CV outcomes data from the ongoing 8,900 patient Light Study. Discussions around the package insert and other post-marketing obligations are ongoing.

"We are working expeditiously with the FDA to finalize the review," said Michael Narachi, CEO of Orexigen. "We are encouraged by the high level of engagement with the FDA, and are confident that we can reach agreement on the remaining post-marketing obligation."

Orexigen management will host a conference call and webcast to discuss this update today at 8:00 a.m. Eastern time. The live call may be accessed by phone by calling 1 [phone] (domestic) or 1 [phone] (international), participant code 37498115. The webcast can be accessed live on the investor relations section of the Orexigen web site at http://www.orexigen.com/ and will be archived for 14 days following the call.
yhoo.it/1inpkqM