DAnIEL tagged this document as irrelevant
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.
No investment advice
The Company is a publisher and is not registered with or authorised by the Financial Services Authority (FSA). You understand and agree that no content published on the Site constitutes a recommendation that any particular security, portfolio of securities, transaction, or investment strategy is suitable or advisable for any specific person. You further understand that none of the information providers or their affiliates will advise you personally concerning the nature, potential, advisability, value or suitability of any particular security, portfolio of securities, transaction, investment strategy, or other matter.
You understand that the Site may contain opinions from time to time with regard to securities mentioned in other products, including company related products, and that those opinions may be different from those obtained by using another product related to the Company. You understand and agree that contributors may write about securities in which they or their firms have a position, and that they may trade such securities for their own account. In cases where the position is held at the time of publication and such position is known to the Company, appropriate disclosure is made. However, you understand and agree that at the time of any transaction that you make, one or more contributors may have a position in the securities written about. You understand that price and other data is supplied by sources believed to be reliable, that the calculations herein are made using such data, and that neither such data nor such calculations are guaranteed by these sources, the Company, the information providers or any other person or entity, and may not be complete or accurate.
From time to time, reference may be made in our marketing materials to prior articles and opinions we have published. These references may be selective, may reference only a portion of an article or recommendation, and are likely not to be current. As markets change continuously, previously published information and data may not be current and should not be relied upon.