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Orexigen and FDA Identify a Clear and Feasible Path to Approval for Contrave®
Date:9/20/2011

forward-looking statements should not be regarded as a representation by Orexigen that any of its plans will be achieved. Actual results may differ from those set forth in this release and the conference call due to the risk and uncertainties inherent in Orexigen's business, including, without limitation: Orexigen's ability to maintain and raise sufficient capital to fund the CVOT and maintain its other operations; the uncertainty of the FDA approval process, including requirements for additional clinical and non-clinical studies or other commitments prior to the submission and approval of an NDA for Contrave; Orexigen's ability to demonstrate that the risk of major adverse CV events in overweight and obese subjects treated with Contrave does not adversely affect the product candidate's benefit-risk profile; the potential for FDA's planned 2012 public advisory committee meeting on obesity drug development to result in additional NDA approval requirements for Contrave as well as post-approval commitments; Orexigen's dependence on Takeda Pharmaceuticals for aspects of the development and commercialization of Contrave; reliance on third parties to supply Contrave and assist with the development of Contrave and the regulatory submissions related thereto; the potential for adverse safety findings relating to Contrave; intense competition in the obesity marketplace and the potential for new products to emerge that provide different or better therapeutic alternatives for obesity and weight loss compared to Contrave; and other risks described in the Company's filings with the Securities and Exchange Commission (SEC). You are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date hereof, and Orexigen undertakes no obligation to revise or update this news release to reflect events or circumstances after the date hereof. Further information regarding these and other risks is included under the heading "Risk Factors" in Orexig
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SOURCE Orexigen Therapeutics, Inc.
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2. Orexigen® Therapeutics Provides a Regulatory Update on Contrave® NDA
3. Orexigen® Therapeutics Reports First Quarter Ended March 31, 2011 Financial Results
4. Orexigen® Therapeutics Reports Fourth Quarter and Year Ended December 31, 2010 Financial Results
5. Orexigen® Therapeutics Schedules March 10, 2011 Webcast Discussion of Financial Results for the Fourth Quarter and Year Ended December 31, 2010
6. Orexigen® Therapeutics, Inc. Announces Upcoming Departure of Chief Financial Officer
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10. Orexigen® Therapeutics to Speak at Rodman & Renshaw Annual Global Investment Conference
11. Orexigen® Therapeutics and Takeda Enter Into Partnership to Commercialize Contrave® in North America
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