MALVERN, Pa. (TheStreet) -- Shares of Auxilium Pharmaceuticals(AUXL Quote) are on the rise Monday morning after a Food and Drug Administration review of the company's experimental drug Xiaflex that was posted to the agency's Web site didn't appear to raise any new safety issues.
Xiaflex is an injectable enzyme that doctors may use as an alternative to surgery to straighten permanently bent fingers caused by a condition known as Dupuytren's contracture. Dupuytren's is a progressive disease in which collagen knots build up in the tendons of the hands, causing finger joints to contract. Xiaflex acts as a nonsurgical knife to break up the collagen knots and help straighten the bent fingers. An FDA advisory committee meets Weds. Sept. 16 to review Xiaflex and vote on whether to recommend the treatment's approval. The FDA posted its review of Xiaflex in advance of the meeting. The FDA review doesn't say specifically whether the agency believes Xiaflex should be approved or not, but it does ask the advisory panel to discuss how much training doctors will need with Xiaflex before treating patients. Three patients treated in the pivotal studies with Xiaflex suffered tendon ruptures. Auxilium shares were up 18% to $35.67 in recent trading.Xoma to Repay Goldman Loan
(At 8:55 AM EDT) Xoma(XOMA Quote) announced a plan Monday to repay a $44 million loan from Goldman Sachs, removing a balance sheet overhang that has concerned investors for months. The company will tap into several sources of funds -- a buyout of future royalties owed by Roche, a stock sale and cash on hand in a restricted account -- to satisfy the Goldman obligation, the company said.- Loading Comments...
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