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Biotech / Medical : biotech firesales

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From: tnsaf	11/10/2008 12:47:47 PM
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XenoPort hits year low on drug application delay Monday November 10, 11:01 am ET XenoPort shares fall on longer-than-expected FDA review timeline for key drug Solzira NEW YORK (AP) -- Shares of XenoPort Inc. plunged to a new year low Monday after the company said $23 million in milestone payments will be delayed after an application for regulatory approval of the company's drug Solzira was withdrawn. The stock fell $4.86, or 12.3 percent, to $34.70 in morning trading. Shares fell to $30.10 early in the trading session, below a 52-week low of $32.77 set a month ago. Early Monday, the company and partner GlaxoSmithKline said they withdrew the Food and Drug Administration application for Solzira in order to reformat some study data at the agency's request. The drug is aimed at treating restless legs syndrome, a neurological disorder characterized by sensations in the legs and an urge to move them for relief. The companies asked for FDA approval of the drug in September. The company said the application will be resubmitted quickly once the reformatting is complete. Despite the delay in payments and the slide in share price, analysts kept a positive view on XenoPort. "The filing withdrawal is more administrative in nature and does not relate to the content of the NDA (application)," wrote Citi analyst Dr. Lucy Lu in a note to investors. She reaffirmed a "Buy" rating and now expects the drug to reach the market by early 2010, instead of in late 2009. Meanwhile, Cowen and Co. analyst Rachel McMinn reaffirmed a "Outperform" rating.

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