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Orexigen Therapeutics Reports Business and Financial Results for the Third Quarter Ended September 30, 2013
Date:11/12/2013

s of the Light Study excluding a prespecified level of risk of MACE; the potential for, and timing of, resubmission of a NDA for Contrave based on interim results of the Light Study; the possibility of resubmitting the Contrave NDA with the independent DMC report on the interim analysis and without the clinical study report for the interim analysis; the safety and effectiveness of Contrave; the potential for, and timing of, the accrual and adjudication of MACE in the Light Study; the probability of overall success of the Light Study; the potential for past Contrave clinical trials to predict the outcome of future Contrave clinical trials; the potential for the FDA to continue to honor the Special Protocol Assessment, or SPA; the potential to enter into a collaborative partnership for commercialization of Contrave outside of North America; the potential for Takeda to commercially launch Contrave in North America; the potential to enter into a collaborative partnership to fund Phase 3 development and, if approved, commercialization of Empatic™; the potential for the FDA to approve an NDA for Empatic without requiring data from a cardiovascular outcomes trial in addition to the data obtained from the Light Study; and the use of pharmacotherapy to treat obesity. The inclusion of forward‐looking statements should not be regarded as a representation by Orexigen that any of its plans will be achieved. Actual results may differ materially from those expressed or implied in this release due to the risk and uncertainties inherent in the Orexigen business, including, without limitation: the possibility that the FDA determines not to initiate review of the Contrave NDA until it has received the complete study report for the interim analysis; the SPA is not binding on the FDA if public health concerns unrecognized at the time the SPA agreement was entered into become evident, other new scientific concerns regarding product safety or efficacy arise, or if Orexigen fai
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4. Orexigen Therapeutics Announces Date of Third Quarter 2013 Financial Results Conference Call and Upcoming Presentation at Credit Suisse Healthcare Conference
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