( BTRX) were among the worst-performing health-related stocks Wednesday, falling 9.6% after the company received a "not approvable" letter from the Food and Drug Administration for Zimycan, the company's treatment for diaper dermatitis complicated by candidiasis.
The company said the FDA action was based on a single deficiency. The FDA said there was insufficient information to characterize the systemic exposure to miconazole in infants. Characterization of systemic exposure to miconazole is a component of the safety evaluation of the product. "We are disappointed and surprised by the FDA's decision; however, Barrier remains dedicated to bringing this product to market," the company said. The company also said that it would continue to work with the FDA and that it would look at all available options. One of its options, Barrier believes, is to conduct a second percutaneous absorption study using the current product. Shares traded down $1.63 to $15.40.
rose 3.4% after the FDA gave the company the green light to resume a phase II clinical trial of TNFerade in rectal cancer that was suspended in October because of safety concerns. The FDA indicated that the clinical hold issues have been satisfactorily addressed for its rectal and esophageal indications. GenVec will resume enrollment for its rectal study; enrollment for its esophageal study is now closed. "We are pleased to resume clinical testing of TNFerade for the treatment of rectal cancer and greatly appreciate the FDA's efforts to resolve the clinical hold on this program," GenVec said. Shares traded up 6 cents to $1.84.
Rita Medical Systems
( RITA) fell 3.4% after the company announced the resignation of its chief financial officer and said its independent audit firm resigned as well. Rita said that Donald Stewart, who is leaving the company to pursue other business interests, would remain with the company until a permanent replacement is found. Rita said the departure of its independent auditor, meanwhile, is unrelated to Stewart's decision to leave the company. According to Rita, there were no disagreements between the company and PricewaterhouseCoopers. What's more, PwC issued unqualified opinions in the company's financial statements from 1997 to 2004. "We regret their decision," Rita Medical said, "but understand that it is the result of PwC's internal strategy and realignment of its resources." Shares traded down 9 cents to $2.60.
fell 3.7% after the company trimmed its 2005 earnings and sales forecasts because of growing competition in the stent market and costs associated with four recent acquisitions. The medical device maker now expects earnings of $1.85 to $2 a share, down from previous guidance of $2 to $2.20 a share. Sales are now expected to be between $6.35 billion and $6.57 billion, which compares with its earlier forecast of $6.4 billion to $6.7 billion. Analysts polled by Thomson First Call had been expecting earnings of $2.06 a share on sales of $6.51 billion. Drug-coated stent sales are now expected to be $2.62 billion to $2.76 billion, down from previous guidance of $2.7 billion to $3 billion. Shares traded down $1.14 to $29.46.
took a breather Wednesday after the company posted a much smaller year-over-year, fourth-quarter loss on a 42% sales jump. The company, which had seen its shares climb by more than 31% during the past week, posted a loss of $427,000, or 1 cent a share, on sales of $3 million. A single analyst following the company was expecting a loss of 4 cents a share on sales of $2.1 million. A year ago the company reported a loss of $3.3 million, or 11 cents a share, on sales of $2.1 million. Last-year's results included a charge of $2.4 million. Shares of Repligen traded down 21 cents to $2.24.
Other health-care volume movers included
( EYET), up $1.68 to $14.63;
( ABRX), up 49 cents to $4.24;
, down 17 cents to $28.67;
, unchanged at $7.21;
( SGP), down 26 cents to $19.74;
, down 20 cents to $32.54;
, up 5 cents to $2.72;
, down 15 cents to $62.38; and
Johnson & Johnson
, down 13 cents to $67.47.