Shares of Encysive Pharmaceuticals ( ENCY) were among the worst-performing health-related stocks Monday, plummeting 47% after the Food and Drug Administration said it needs more information about Thelin, the company's pulmonary arterial hypertension drug, before it can be approved. Encysive said the approvable letter from the FDA also includes a request for additional clinical trial work. "We will work in close collaboration with the FDA to clarify the path forward," the company said in a statement issued late Friday. "We are hopeful that this can be accomplished without the need for additional clinical work, but that will require discussion with the agency before we can be sure." Shares recently were trading down $4.28 to $4.80. Shares of Myogen ( MYOG), which is developing a rival drug, were trading up $1.63, or 5%, to $36.61. DexCom ( DXCM) jumped 11% after the FDA approved the company's STS continuing glucose monitoring system, which is used by diabetics who want to manage their blood sugar levels. The device consists of a tiny wire-like sensor that is inserted just under the skin to measure glucose levels, which are transmitted wirelessly to a cell phone-like receiver. DexCom shares were up $2.13 to $21.94. Shares of Keryx Biopharmaceuticals ( KERX) rose 3% after the biotech company laid out plans to sell almost $83 million worth of stock to two institutional investors. The company, which plans to sell 4.5 million shares at $18.40 apiece as part of a registered direct offering, expects the stock sale to close Tuesday. Shares were trading up 56 cents to $19.04. Santarus ( SNTS) rose 5% after the FDA approved the company's new drug application for Zegerid chewable tablets, an immediate-release proton pump inhibitor that's used to treat heartburn. "We are evaluating the positioning and launch timing of the chewable tablet dosage form and do not currently anticipate that the commercial launch of this product will occur in 2006," Santarus said. Shares recently changed hands at $6.57, up 32 cents.
Shares of Allergan ( AGN) rose modestly after the Botox maker issued in-line 2006 earnings guidance. The company, which recently acquired Inamed, sees earnings of $3.56 to $3.62 a share, including 20 cents in stock-based compensation costs. The company predicts total revenue, including sales from Inamed, of $2.81 billion to $2.95 billion. Analysts polled by Thomson First Call project earnings of $3.56 a share, including stock-based compensation costs. For the first quarter, Allergan predicts earnings of 80 cents to 81 cents a share, including 4 cents a share in stock-based compensation costs. The company sees first-quarter revenue of $600 million to $610 million, excluding sales from Inamed. Analysts project earnings of 82 cents a share and revenue of $616.9 million. Allergan shares were trading up 48 cents to $112.40. Other health care volume movers included Generex Biotechnology ( GNBT), down 57 cents to $3.15; Pfizer ( PFE), down 32 cents to $25.70; UnitedHealth Group ( UNH), down 81 cents to $54.97; Bristol-Myers Squibb ( BMY), down 46 cents to $25.06; AstraZeneca ( AZN), down $1.25 to $50.48; Biomet ( BMET), up 69 cents to $35.01; Cephalon ( CEPH), down $2.59 to $61.21; Boston Scientific ( BSX), up 16 cents to $23.65; Novavax ( NVAX), up 5 cents to $7.56; Elan ( ELN), up 21 cents to $14.09; Johnson & Johnson ( JNJ), down 58 cents to $59.81; Amgen ( AMGN), down 34 cents to $72.84; Merck ( MRK), down 5 cents to $36; and Schering-Plough ( SGP), down 10 cents to $19.24.