Orexigen receives three month extension of FDA NB32 review Orexigen announced that the FDA has extended its review of the resubmitted New Drug Application for NB32, the company's investigational medication being evaluated for weight loss. The new Prescription Drug User Fee Act action date has been set for September 11. 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 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.
Orexigen price target lowered to $11 from $21 at Piper Jaffray Piper Jaffray analyst Charles Duncan cut his price target for Orexigen shares to $11 saying traction for Contrave, while good, is slightly below his expectations. He continues to view Contrave as a "novel asset" with large market potential of $700M in annual revenue, however. Duncan views the company's current market capitalization of $270M as a "market inefficiency" relative to the potential of the Contrave franchise. Duncan reiterates an Overweight rating on Orexigen.