Vertex Pharmaceuticals Inc. (NASDAQ:VRTX) announced that the U.S.health regulators have granted priority review for KALYDECO, thecompany's lead medicine in development to treat cystic fibrosis (CF).
On Thursday, the stock rose 1.6 percent to $31.04 in pre-market trading.
KALYDECO targets the defective protein that causes CF in a subset ofpeople with the disease. "If approved, KALYDECO will be the firsttreatment to target the underlying cause of CF," the Cambridge,Massachusetts-based company said.
The U.S. Food and Drug Administration (FDA) has set a six-month target review date of April 18, 2012.
Vertex also announced that its marketing authorization application(MAA) for KALYDECO has been validated by the European Medicines Agency(EMA).
CF is a life-threatening genetic disease affecting around 30,000people in the United States and 70,000 people worldwide. CF is caused bydefective or missing cystic fibrosis transmembrane conductanceregulator proteins resulting from mutations in the CFTR gene.
In a separate statement, the company also announced that it appointedJeffrey Leiden as President and Chief Executive Officer (CEO),effective February 1, 2012.
VRTX, which has been trading in the 52-week range between $26.50 and $58.87, ended Wednesday's regular trading at $30.54.
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