United Therapeutics Gets Approvable Letter for Remodulin
Updated from 9:21 a.m. EST
Shares of United Therapeutics (UTHR Quote) jumped 23% Monday after the biotech company received an "approvable letter" from the Food and Drug Administration for its drug Remodulin to treat pulmonary arterial hypertension. The biotech firm said final approval is contingent on discussions with the FDA over the drug's labeling. The regulatory agency will also require United Therapeutics to conduct a post-approval study of Remodulin to verify its clinical benefit.
United Therapeutics was up $2.15, or 23%, to $11.50 in recent Monday trading.
Pulmonary arterial hypertension is a disease in which elevated blood pressure in the lungs causes shortness of breath and heart damage. About 50,000 people in North America and Europe suffer from various forms of the life-threatening disease, according to the company. ...
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