Biotech Values

[Bio_pete]

Cort -up over $2.00 today. Geeez, and my newsletter told me not to get to excited about the stock. Heck, I'd be doing cartwheels.

Corcept Therapeutics Receives FDA Notification Opening IND for CORLUX(R) for the Treatment of Cushing's Syndrome
Tuesday September 11, 9:00 am ET

MENLO PARK, CA--(MARKET WIRE)--Sep 11, 2007 -- Corcept Therapeutics Incorporated (NasdaqCM:CORT - News) today announced that it has received notification from the Food and Drug Administration (FDA) that the FDA has opened the Investigational New Drug application (IND) for CORLUX for the treatment of Cushing's Syndrome. CORLUX is a cortisol receptor (GR-II) antagonist.

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In July 2007, the Company announced the receipt of Orphan Drug Designation for CORLUX for the treatment of Cushing's Syndrome. Drugs that receive Orphan Drug Designation obtain seven years of marketing exclusivity from the date of drug approval as well as tax credits for clinical trial costs, marketing application filing fee waivers and assistance from the FDA in the drug development process.

In the communication regarding the opening of the IND, the FDA indicated that a single study may provide a reasonable basis for the submission of a New Drug Application (NDA) for Corlux for the treatment of Cushing's Syndrome, which allows us to initiate the 50-patient open label study defined by the protocol submitted with the application for the IND. Corcept has begun qualifying potential sites for this study and expects to open the trial for enrollment late in the fourth quarter of 2007.

Joseph K. Belanoff, M.D., Corcept's Chief Executive Officer, commented, "We are pleased that the FDA has allowed us to open our IND for CORLUX for the treatment of Cushing's Syndrome and to initiate the Phase 3 protocol included in the IND submission. We look forward to advancing a potential treatment for this rare illness."

http://biz.yahoo.com/iw/070911/0300405.html