FDA accepts Encysive's Thelin response.........stock soars
Thu Jun 15, 2006 2:47 PM ET


NEW YORK, June 15- Encysive Pharmaceuticals Inc. on Thursday said U.S. regulators accepted the company's response regarding its application for its Thelin drug, and will decide whether to approve the product by July 24, sending the company's shares soaring by as much as 43 percent.

Thelin is under review as a treatment for pulmonary arterial hypertension, a serious lung condition. The U.S. Food and Drug Administration in March deemed Thelin "approvable." The specter of new clinical trials and a potentially extensive delay to the drug had crippled the stock.

"It is a surprise," Rodman & Renshaw analyst Navdeep Jaikaria said of the speedy decision on Thelin. "Nobody was expecting it."

Shares of Encysive jumped $1.84, or 36 percent, to $6.89 in afternoon Nasdaq trade, after earlier hitting $7.24.

An FDA spokeswoman said in March the drug could be cleared should certain conditions be met, but did not specify what those conditions were.

Encysive said then that the FDA's approvable letter contained "a request for additional clinical trial work."

The company expects European regulators to make a decision within the next three months on Thelin, after the drug won a positive recommendation from a panel of experts earlier this month.

Thursday's news of the accepted response on Thelin may be viewed as a negative for Swiss biotechnology company Actelion (NASDAQ ATLN ), which relies on its PAH treatment Tracleer to sustain growth.

Jaikaria, who projects peak annual sales of Thelin at $200 million, said by getting to market sooner, Thelin would gain an edge against another PAH drug being developed by biotechnology company Myogen Inc. (Nasdaq MYOG)

"It positions Encysive favorably as they will be coming to market earlier than expected," Jaikaria said.