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Hemispherx Biopharma shares rise on FDA extension of new drug application Wed 3:59 pm by Deborah Sterescu

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Hemispherx Biopharma shares rise on FDA extension of new drug application Wed 3:59 pm by Deborah Sterescu

Hemispherx BioPharma (AMEX:HEB) shares rose on Wednesday after announcing that the FDA granted an extension for the company to modify its new drug application (NDA) for Ampligen, a potential treatment for chronic fatigue syndrome (CFS).

The modification to the NDA is in response to the complete response letter received by the company in November 2009 for the CFS therapeutic indication.

The extension will remain open while Hemispherx submits an amended NDA, the company said.

Last year, a team of researchers at the Centers for Disease Control (CDC) and Harvard University reported new data on the magnitude of the medical and economic impact of untreated CFS.

In its statement, Hemispherx cited that according to the study, "CFS patients, their families, employers and society bear significant costs associated with the illness. The symptoms characterizing CFS are common to many illnesses, hence diagnosis is complex… and requiring extensive diagnostic testing and clinical assessment."

In the request for extension, the company said it advised the FDA of the findings presented at the IACFS/ME Biennial Scientific Conference held in September of last year in Ottawa, Ontario, Canada, of a new potential companion diagnostic test for CFS.

"We continue to move forward and are working diligently to pursue approval for Ampligen® as the first treatment for Chronic Fatigue Syndrome in the U.S. and other countries," said chief medical director of Hemispherx, Dr. David Strayer.

Ampligen is an experimental RNA nucleic acid being developed for debilitating diseases and disorders of the immune system.

Shares of the company jumped over 14 percent to trade at 24 cents near market close on Wednesday.

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