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  • BeaconEquity.com: Orexigen (OREX) Soars on Phat FDA Agreement for Obesity Drug 0 comments
    Sep 21, 2011 5:20 PM | about stocks: OREX
    Orexigen Therapeutics Inc. spiked more than 58% this morning on word the company reached an agreement with the U.S. FDA that enables it to renew development of Contrave, its experimental obesity drug. The FDA rejected the Contrave New Drug Application (NDA) back in January this year.

    Orexigen shares roared 70% in pre-market trading, following news of obesity drug’s revival.

    Orexigen is one of three companies looking for an approval for weight loss treatment. In a Complete Response Letter to Orexigen, the FDA raised concerns about the cardiovascular risks relating to Contrave.

    Orexigen yesterday said that following a recent meeting with senior officials of the FDA’s Office of New Drugs, it received details on design requirements for cardiovascular outcomes trial for the drug that would address the concerns raised in the letter in January.

    The company said that the FDA’s design requirements are reasonable and feasible and offer the certainty required to reinitiate development of Contrave.

    Michael Narachi, president and CEO of Orexigen, said that the company has been working with clinical experts, advocacy groups, and its partner, Takeda, throughout the process and is pleased with the feedback provided by the FDA.

    Please see disclaimer on the QualityStocks website: disclaimer.qualitystocks.net
     
    Stocks: OREX
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