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FDA Accepts Corcept Therapeutics' Submission Of NDA For CORLUX - Quick Facts

Corcept Therapeutics Inc. (CORT) announced that the U.S. Food and Drug Administration, or FDA, has accepted for filing the New Drug Application, or NDA, which was submitted on April 15, 2011, for CORLUX, a glucocorticoid receptor type II antagonist, for the treatment of the manifestations of Cushing's Syndrome.

FDA has indicated that the application will receive a standard review and that the Prescription Drug User Fee Act goal date for completion of its review is February 17, 2012, Corcept Therapeutics noted.

Joseph Belanoff, chief executive officer at Corcept Therapeutics, satted, "In our Phase 3 study, CORLUX demonstrated its potential to significantly improve the clinical condition of these patients in a wide variety of important ways. We believe that CORLUX has the potential to provide a meaningful advance over the current standard of care for patients with Cushing's Syndrome and are gratified to receive the formal notice of the FDA's acceptance of the NDA for filing."

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