Lixivaptan regulatory update

Cornerstone said FDA issued a complete response letter for an NDA for lixivaptan to treat hypervolemic hyponatremia associated with chronic heart failure (CHF) and euvolemic hyponatremia associated with syndrome of inappropriate antidiuretic hormone (SIADH). According to the company, the agency requested additional clinical and non-clinical information. Cornerstone declined to provide additional details about the letter, including whether they would need to conduct additional trials. ...