Adam Feuerstein
Shares in United Therapeutics(UTHR Quote - Cramer on UTHR - Stock Picks) are off more than 21% Monday as investors reacted to last week's drug development setback.
On Thursday, April 12, the biotechnology firm said it reached an agreement with the U.S. Food and Drug Administration to extend for up to 90 days the review of Remodulin, a new drug to treat pulmonary arterial hypertension. The company will use the additional time to provide the FDA with more information to support the drug's approval, the company said. The disappointing news was released after the bell Thursday and right before the Good Friday market holiday. On Monday, shares in United Therapeutics were off $3.20, or more than 21%, to $11.70 in recent tradingA. Shares were off as much as 32% earlier in the day. United Therapeutics submitted Remodulin for approval to the FDA in October 2000. At the time of the submission, U.S. drug regulators agreed to an accelerated review period, which could have allowed Remodulin to be approved as early as this month. As a result of the delay, the company now says its previously released revenue forecasts are no longer accurate, and will be updated once the FDA takes action of the Remodulin application. The company was expected to lose 46 cents in the first quarter, 48 cents in the second quarter and $1.76 for the full-year 2001, according to Thomson Financial/First Call.
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