UPDATE 1-Hemispherx says FDA to review analyses on fatigue drug

Wed Jul 11, 2012 9:10pm IST

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* Says to respond to FDA in Q3

* FDA agrees to review new analyses of late-stage data

July 11 (Reuters) - Hemispherx Biopharma Inc said U.S. regulators agreed to accept for review new analyses of data from a late stage trial of Ampligen, its experimental drug for treating chronic fatigue syndrome.

The new analyses, if found sufficient, will be in lieu of an additional study that the regulator had sought three years ago, Hemispherx said in a statement.

The company said it plans to submit its response to the FDA in the third quarter of 2012.

The specialty pharmaceutical company's stock soared as much as 50 percent, rekindling hopes for the drug that has lost its way for about five years. It was first filed for approval in October 2007.

In November 2009, the U.S. Food and Drug Administration had called for at least one additional clinical study of Ampligen, including at least 300 patients on dose regimens intended for marketing.

Hemispherx's cash reserve, which was about $58.1 mln at the end of 2009, fell to $3.7 million by the end of March this year, according to a regulatory filing.

Hemispherx's shares were trading up 28 percent at 36 cents on the NYSE Amex, after touching a high of 42 cents.

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