Encysive stock plummets on second drug approval delay
Encysive Pharmaceuticals Inc.'s stock took a 40 percent nosedive on Tuesday morning after the company announced another delay in the approval of its pulmonary arterial hypertension drug, Thelin.
In a statement issued late Monday, Houston-based Encysive (NASDAQ:ENCY - News) said it was informed by the U.S. Food and Drug Administration in an approvable letter that it had an outstanding item related to a separate letter issued in March.
In its latest approvable letter, the FDA said that the unresolved item is a matter of judgment and expressed an openness to consider new arguments to address this remaining item, according to Encysive.
The FDA also again suggested the alternative of conducting additional clinical work. The agency also made recommendations on the company's risk management plan, which Encysive said it views as "constructive."
The news is the latest in a roller-coaster ride for Encysive as the company has worked toward U.S. approval of Thelin. The drug was recommended for approval in Europe last month.
In mid-June, Encysive shares hopped after the company said the FDA was reviewing its drug to treat high blood pressure in the pulmonary arteries, a condition called pulmonary arterial hypertension.
The company's stock ended the regular trading session on June 15 up 38.8 percent at $7.01, after rocketing to $7.24 for a gain of 43.3 percent earlier in the day.
On Tuesday morning, Encysive shares were trading at $3.72 after having traded as low as $3.43 earlier in the day -- far lower than the company's 52-week-high of $13.29.
Analyst firm Rodman & Renshaw swiftly downgraded Encycive's stock from "Market Outperform" to "Market Perform." Meanwhile, WR Hambrecht + Co analyst Patrick E. Flanigan III said Encysive's receipt of a second approvable letter "raises a shadow of doubt over the drug's approvability in the U.S." since it remains unclear as to whether or not the firm will need to conduct an additional clinical trial. WR Hambrecht maintained a "Hold" rating on the stock.
Encysive Pharmaceuticals Inc.'s stock took a 40 percent nosedive on Tuesday morning after the company announced another delay in the approval of its pulmonary arterial hypertension drug, Thelin.
In a statement issued late Monday, Houston-based Encysive (NASDAQ:ENCY - News) said it was informed by the U.S. Food and Drug Administration in an approvable letter that it had an outstanding item related to a separate letter issued in March.
In its latest approvable letter, the FDA said that the unresolved item is a matter of judgment and expressed an openness to consider new arguments to address this remaining item, according to Encysive.
The FDA also again suggested the alternative of conducting additional clinical work. The agency also made recommendations on the company's risk management plan, which Encysive said it views as "constructive."
The news is the latest in a roller-coaster ride for Encysive as the company has worked toward U.S. approval of Thelin. The drug was recommended for approval in Europe last month.
In mid-June, Encysive shares hopped after the company said the FDA was reviewing its drug to treat high blood pressure in the pulmonary arteries, a condition called pulmonary arterial hypertension.
The company's stock ended the regular trading session on June 15 up 38.8 percent at $7.01, after rocketing to $7.24 for a gain of 43.3 percent earlier in the day.
On Tuesday morning, Encysive shares were trading at $3.72 after having traded as low as $3.43 earlier in the day -- far lower than the company's 52-week-high of $13.29.
Analyst firm Rodman & Renshaw swiftly downgraded Encycive's stock from "Market Outperform" to "Market Perform." Meanwhile, WR Hambrecht + Co analyst Patrick E. Flanigan III said Encysive's receipt of a second approvable letter "raises a shadow of doubt over the drug's approvability in the U.S." since it remains unclear as to whether or not the firm will need to conduct an additional clinical trial. WR Hambrecht maintained a "Hold" rating on the stock.
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