FDA letter : $4.83
Cornerstone Therapeutics receives Complete Response letter from the FDA for lixivaptan (CRTX) 4.89 : Co announced that it received a Complete Response Letter (CRL) from the FDA for its New Drug Application (NDA) for lixivaptan for the treatment of symptomatic hypervolemic and euvolemic hyponatremia associated with heart failure and syndrome of inappropriate antidiuretic hormone (SIADH), respectively. The Complete Response Letter requests additional clinical and non-clinical information in order for the FDA to consider approval of lixivaptan. The Company intends to request an End-of-Review meeting with the Division of Cardiovascular and Renal Products to better understand the contents of the CRL.
Briefing note: A complete response letter was expected given the negative FDA panel vote lixivaptan received from an FDA Advisory Committee on September 13 for both indications.