Encysive Pharmaceuticals Blind-Sided: Thelin Receives Approvable Letter from FDA

For Encysive Pharmaceuticals, Inc. (ticker: ENCY) investors, Monday was one of those days that biotech investors abhor – a day when what appeared to be a sure bet, or as close as a sure bet one can get in biotechland, goes south. Encysive lost almost half its market value today on news released after the close Friday that the company’s drug Thelin received an approvable letter from FDA. The news came as a shock as most investors assumed FDA would outright approve the drug.

Although the company is being tight-lipped on exactly what FDA’s issues are, the company stated in its press release that the “letter contains concerns and observations that must be satisfied prior to achieving approval, including a request for additional clinical trial work.