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Theratechnologies Stock Soars After FDA Committee Votes on Tesamorelin Drug

By Pharmaceutical Processing | May 28, 2010

Shares of Theratechnologies shot up 85 per cent in early Friday trading after the company announced a step towards approval for marketing its tesamorelin drug.

The company’s stock was ahead $2.40 to $5.30 on the Toronto Stock Exchange in the early morning.

On Thursday, the Montreal-based company said that a U.S. Food and Drug Administration committee voted 16-0 that the drug, used to treat excess abdominal fat in HIV patients with lipodystrophy, should be granted marketing approval by the FDA.

The FDA ultimately makes the decision on marketing approval, though it takes the recommendations into account.

“The advisory committee recommendation is another important step forward for the company,” said company president and CEO Yves Rosconi in a release.

“It is especially significant for those patients who suffer from this serious metabolic complication, where today no treatment option exists.”

Theratechnologies expects the FDA will complete its review of the new drug application by July 27.

 

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