SAN DIEGO and PHILADELPHIA, Jan. 17, 2013 /PRNewswire/ -- Shareholder rights attorneys at Robbins Arroyo LLP announce that purchasers of Hemispherx Biopharma, Inc. (NYSE: HEB) ("Hemispherx" or the "Company") have filed a complaint in the U.S. District Court for the Eastern District of Pennsylvania. The complaint alleges the Company and certain of its officers and directors violated the Securities Exchange Act of 1934 between March 19, 2012 and December 17, 2012 (the "Class Period"). Hemispherx is a biopharmaceutical company that focuses on the development of new drug therapies to treat viral and immune based chronic disorders.
The complaint alleges that the Company issued a series of materially false and misleading statements to investors regarding the safety and efficacy of Ampligen®, a drug intended as a treatment for Chronic Fatigue Syndrome. Specifically, the complaint alleges that Hemispherx misrepresented and failed to disclose that Ampligen did not meet safety and efficacy requirements because its clinical trials were not properly designed.
Hemispherx submitted a New Drug Application to the U.S. Food and Drug Administration ("FDA") for Ampligen in 2007. In 2009, the FDA found that the Phase III study did not adequately support the approval of Ampligen.In a July 11, 2012 press release, Hemispherx announced that rather than conducting a new clinical trial, it reached an agreement with the FDA to submit post-hoc analysis of Ampligen for FDA consideration. However, in a meeting held in June 2012 between Hemispherx and FDA officials concerning Hemispherx's ability to gain approval for Ampligen, the FDA noted that "[i]t would be unusual for this type of data to provide adequate evidence of efficacy." Upon review of the post-hoc analyses, on December 18, 2012, the FDA released a report citing that the additional information submitted by the Company was insufficient. The report further stated that the Company's studies were "ill-defined and invalid," noting inconsistencies regarding the effectiveness and finding nine potential safety concerns. As a result of this news, Hemispherx shares declined $0.276 per share, or approximately 43%, closing at $.368 per share on December 18, 2012. If you purchased or otherwise acquired Hemispherx stock during the Class Period and wish to serve as lead plaintiff, you must act no later than February 22, 2013. To discuss your shareholder rights, please contact attorney Darnell R. Donahue at (800) 350-6003, email@example.com, or via the shareholder information form on the firm's website. Robbins Arroyo LLP is a nationally recognized leader in securities litigation and shareholder rights law. The firm represents individual and institutional investors in shareholder derivative and securities class action lawsuits, and has helped its clients realize more than $1 billion of value for themselves and the companies in which they have invested. For more information, please go to http://www.robbinsarroyo.com. Press release link: http://www.robbinsarroyo.com/shareholders-rights-blog/hemispherx-biopharma-inc/ Attorney Advertising. Past results do not guarantee a similar outcome.