(By Balaseshan) Hemispherx BioPharma Inc. (NYSEAMEX:HEB) shares jump 11.39% in premarket after the U.S. regulatory authorities has accepted its complete response submission regarding the Ampligen new drug application for chronic fatigue syndrome.
Ampligen represents the first drug in the class of large (macromolecular) RNA (nucleic acid) molecules to apply for New Drug Application (NDA) review in the United States. Ampligen is an experimental RNA nucleic acid being developed for globally important debilitating diseases and disorders of the immune system including Chronic Fatigue Syndrome.
The company filed on July 31 with the U.S. Food and Drug Administration its complete response to the FDA's November 25, 2009 Complete Response Letter in support of Ampligen's New Drug Application for Chronic Fatigue Syndrome.
The Ampligen data were organized and filed with the FDA 53 days after the June 8 meeting with the Agency. At present, no drug has received FDA approval to treat CFS, a chronic, seriously debilitating disease.
On August 10, the FDA acknowledged in writing receipt of the company's August 1, response stating, "We consider this a complete, class 2 response to our November 25, 2009, action letter. Therefore, the user fee goal date is February 2, 2013."
"While the FDA's acceptance of our resubmission does not commit the Agency to approve the Ampligen NDA, the company is pleased to have the opportunity for FDA review and consideration. As the user fee goal date is February 2, 2013, we hope to receive a decision by the FDA on or before that date," said Thomas Equels, Vice Chairman of Hemispherx.
HEB closed Monday's regular session at $0.440. The stock has been trading between $0.17 and $0.50 for the past 52 weeks.