Corcept Therapeutics drug Korlym gets FDA approval

Corcept Therapeutics' Korlym gets FDA OK for high blood sugar in Cushing's Syndrome patients

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NEW YORK (AP) -- Shares of Corcept Therapeutics Inc. surged in late trading Friday after the company received regulatory approval for Korlym, the first available treatment for high blood sugar in patients with the endocrine disorder Cushing's Syndrome who cannot have surgery.

The Food and Drug Administration approved Korlym, or mifepristone, as a once-a-day therapy for adults who have hyperglycemia plus Type 2 diabetes or glucose intolerance and who have failed surgery or are not candidates for surgery.

Cushing's Syndrome results when tumors or another factor causes a person's body to produce too much of the hormone cortisol. The syndrome's symptoms can include high blood sugar, high blood pressure, fatigue and muscle weakness. Corcept said about 20,000 people in the U.S. have the condition, primarily women between the ages of 20 and 50. The drug is contraindicated in pregnant women.

The Menlo Park, Calif., company said it plans to make Korlym available by May 1. Because the drug has been designated an orphan drug, Corcept will have exclusive marketing rights until February 2019. It is Corcept's only product on the market.

Corcept shares leaped 62 percent after hours to $4.90. During regular trading, they gained 15 cents, or 5.2 percent, to close at $3.03. Over the past year, they've traded between $2.50 and $5.07.

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