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Case Details for "Hemispherx Biopharma, Inc. "

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Hemispherx Biopharma, Inc Named in Securities Class Action Lawsuit

The class action is brought on behalf of all purchasers of Hemispherx Biopharma, Inc. ("Hemispherx" or the "Company") (Amex: HEB) securities between February 18, 2009 and December 1, 2009, inclusive (the "Class Period").

Hemispherx is a specialty pharmaceutical company engaged in the clinical development, manufacture, marketing, and distribution of new drug therapies for the treatment of viral and immune-based chronic disorders. The Company's products include Ampligen, an experimental drug undergoing clinical development for treatment of chronic fatigue syndrome.

The complaint alleges that Hemispherx and its principal officer and director violated the federal securities laws by making a series of false statements about postponements of action on Hemispherx's New Drug Application ("NDA") for Ampligen with the U.S. Food and Drug Administration ("FDA"). Specifically, the defendants portrayed the postponements as due to matters such as FDA staffing issues, while concealing that: (a) the delays were due to the Company's failure to submit a number of reports that had been requested by the FDA and which were necessary before review of the drug could be completed; (b) questions had been raised about the adequacy of data submitted with the NDA to demonstrate the drug's efficacy; and (c) the drug could not be approved unless the FDA waived its requirement for two rodent carcinogenicity studies. When Hemispherx belatedly disclosed this information on November 2, 2009, the price of Hemispherx stock dropped 22% from $1.45 per share, to close at $1.13 per share on November 3, 2009.

Then on December 1, 2009, after the market closed, Hemispherx announced that the FDA had denied the Ampligen NDA. The December 1, 2009 press release stated that the FDA concluded that the Company had not submitted "credible evidence of efficacy of Ampligen," and also lacked required testing for carcinogenicity in animals, which defendants admitted they had asked the FDA to waive. On this news, the price of Hemispherx stock dropped an additional 40% from $1.20 per share, to close at $0.71 per share on December 2, 2009.

 

Posted on: 01/07/2010
Company/Organization: Hemispherx Biopharma, Inc.
Scope: Nationwide
Affected Class: Purchasers between February 18, 2009 and December 1, 2009
Type of Case: Securities

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