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June 11, 2014
06:31 EDTOREXOrexigen 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.
News For OREX From The Last 14 Days
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September 18, 2014
10:03 EDTOREXOrexigen management to meet with Leerink
Meetings to be held in New York on September 23 and in Boston on September 24 hosted by Leerink.
September 17, 2014
07:43 EDTOREXBofA/Merrill to hold a conference
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05:51 EDTOREXStocks with implied volatility movement; OREX MNKD
Stocks with implied volatility movement; Orexigen (OREX) 91, MannKind (MNKD) 60 according to iVolatility.

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