BioCentury
ARTICLE | Company News

FDA panel votes against lixivaptan

September 14, 2012 12:28 AM UTC

Cornerstone Therapeutics Inc. (NASDAQ:CRTX) fell $1.37 (21%) to $5.10 on Thursday after FDA's Cardiovascular and Renal Drugs Advisory Committee recommended against approval of lixivaptan to treat hypervolemic hyponatremia associated with chronic heart failure (CHF) and euvolemic hyponatremia associated with syndrome of inappropriate antidiuretic hormone (SIADH). The committee voted 8-0 against the CHF indication and 5-3 against the SIADH indication. The selective vasopressin V2 receptor antagonist has an Oct. 29 PDUFA date. The company could not be reached for comment. ...