DALLAS, Jan. 31, 2011 (GLOBE NEWSWIRE) -- MicroStockProfit.com announces an investment report featuring Arena Pharmaceuticals Inc. (Nasdaq:ARNA). The report includes financial, comparative and investment analyses, and industry information you need to know to make an educated investment decision.
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Arena Pharmaceuticals (ARNA) is a clinical-stage biopharmaceutical company focused on discovering, developing and commercializing oral drugs that target G protein-coupled receptors (GPCRs) in four major therapeutic areas: cardiovascular, central nervous system, inflammatory and metabolic diseases. The Company's advanced drug candidate is lorcaserin, for weight management, which has completed a pivotal Phase III clinical trial program. It submitted a new drug application (NDA) for lorcaserin to the U.S. Food and Drug Administration (FDA) for regulatory approval in December 2009. The FDA then issued a Complete Response Letter (CRL) in October 2010, outlining non-clinical and clinical reasons for its decision to not approve the drug, and provided recommendations relating to addressing the issues it raised in the CRL.
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In the report, the analyst notes:
"Shares of ARNA slumped last week on news that the FDA is requesting more safety studies to approve its experimental weight-loss drug, lorcaserin -- suggesting a possible delay in the drug's launch. The FDA asked the Company to provide additional studies, including a separate 12-month trial in female rats to determine whether transient prolactin elevation mediated by short-term exposure to lorcaserin can result in mammary tumors in rats.
"'Our ongoing discussions with the FDA reflect our commitment to addressing the issues raised in the CRL to the agency's satisfaction,' ARNA president and CEO Jack Lief said in statement. 'We now have a greater understanding of the FDA's position as we move forward with our plans to resubmit the lorcaserin NDA.'"
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