Cornerstone Therapeutics Inc. (CRTX) recently announced that the Cardiovascular and Renal Drugs Advisory Committee (CRDAF) of the US Food and Drug Administration (:FDA) gave a negative opinion regarding the New Drug Application (:NDA) for lixivaptan (CRTX 080).
Cornerstone is seeking approval for lixivaptan for the treatment of symptomatic hypervolemic and euvolemic hyponatremia associated with heart failure and syndrome of inappropriate antidiuretic hormone (:SIADH), respectively.
Cornerstone added lixivaptan to its pipeline through its acquisition of Cardiokine Biopharma. On December 29, 2011, Cardiokine had filed an NDA with the FDA for lixivaptan.
In March this year, Cornerstone announced that the US regulatory body accepted the NDA submission. The final decision from the FDA is expected on October 29 this year.
Lixivaptan reduces the action of a hormone (vasopressin) which restricts fluid excretion. The company stated in its press release that around six million people in the US are affected by hyponatremia.
We note that in June 2012, Cornerstone added two more cardiovascular products, Cardene IV and Retavase, through its EKR Therapeutics acquisition. While Cardene IV is marketed for the short-term treatment of hypertension, Retavase is marketed for the management of acute myocardial infarction in adults.
Cornerstone shares were down significantly following the news. Although the FDA is not bound to accept the recommendation of the advisory committee, it usually does so. The company intends to continue its discussion with the regulatory authority through out the approval process.
We currently have a Neutral recommendation on Cornerstone. The stock however carries a Zacks #1 Rank (Strong Buy rating) in the short run.
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