Cornerstone Therapeutics Inc.
) recently announced that the Cardiovascular and Renal Drugs
Advisory Committee (CRDAC) 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
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
CORNERSTONE THR (CRTX): Free Stock Analysis
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