Updated from 9:21 a.m. ESTShares of United Therapeutics (UTHR - Get Report) 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 Gets Approvable Letter for Remodulin
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