Cornerstone Therapeutics Inc. (CRTX) said Thursday that a panel of the U.S. Food and Drug Administration has recommended not to approve its investigational drug lixivaptan to treat hyponatremia - a condition that occurs when there is not enough sodium (salt) in the blood.
The news had a deleterious impact on shares of the company, losing about 21.0 percent of its value at the close of market. In after-hours trade, the stock further slid 6.5 percent to $4.76.
The FDA panel, known as the Cardiovascular and Renal Drugs Advisory Committee, rejected lixivaptan for the treatment of symptomatic hypervolemic and euvolemic hyponatremia associated with heart failure and syndrome of inappropriate antidiuretic hormone, respectively.
The FDA usually consider the panel's recommendations even as it is not bound to do so. A final decision on lixivaptan is set for October 29.
Hyponatremia is commonly seen among hospitalized patients and is said to affect up to six million people in the U.S. Though often diagnosed in patients with heart failure, hyponatremia can also be caused by burns, diuretic medications, kidney disease, liver cirrhosis and syndrome of inappropriate antidiuretic hormone.
Lixivaptan, a highly potent, non-peptide oral capsule, is said to work by acting specifically on a hormone - vasopressin-2 receptor in the kidneys, causing water to be excreted while sparing sodium without affecting other electrolytes.
Shares of Cornerstone Therapeutics closed Thursday's regular trade at $5.10, down $1.37 or 21.17%, on the Nasdaq. In after hours, the stock further dropped $0.33 or 6.51%.
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