NEW YORK, May 10, 2013 /PRNewswire/ -- Bernstein Liebhard LLP today announced that a securities class action has been commenced in the United States District Court for the District of Massachusetts on behalf of a class (the "Class") of purchasers of Aveo Pharmaceutical, Inc. ("Aveo" or the "Company") (NASDAQ: AVEO) securities between January 3, 2012 and May 1, 2013 (the "Class Period").
Aveo is a biopharmaceutical company focused on discovering, developing, and commercializing cancer therapies. The Company's lead product is an oral inhibitor of the vascular endothelial growth factor ("VEGF") receptors.
The Complaint alleges that throughout the Class Period, Defendants conditioned investors to believe that the Company's drug Tivopath (or Tivozanib) would receive approval from the U.S. Food and Drug Administration ("FDA") through a host of materially false and misleading statements regarding its Phase III ("TIVO-1") trial design and results. Specifically, the Company (a) failed to disclose to investors that the FDA had recommended that the Company conduct an additional Phase III trial due to adverse trends in the Company's first study; (b) misled investors regarding the overall safety and efficacy of the product, including failing to disclose the 25% higher rate of death associated with Tivozanib therapy compared to the control drug, Sorafenib; and (c) failed to disclose that almost 90% of the patients studied in TIVO-1 were enrolled from sites in Central and Eastern Europe with inconsistent treatment patterns from those in the U.S. As a result of the foregoing, the Company's statements were materially false and misleading at all relevant times.
On April 30, 2013, the FDA released its Oncologic Drugs Advisory Committee ("ODAC") briefing document (the "Briefing Document") that, among other things, took particular issue with the rigor of the Tivozanib trial. The Briefing Document also highlighted the regulatory history of Tivopath, and the fact that the Company disregarded explicit FDA recommendations that the Company conduct an additional Phase III trial. On this news, the Company's shares fell $2.33 or 31.31% per share to close at $5.11 on April 30, 2013, on volume of over 15 million shares.On May 2, 2013, the ODAC voted by an overwhelming majority (13 to 1) not to recommend approval of Tivozanib, because "the application...did not demonstrate a favorable benefit-to-risk evaluation for the treatment of advanced renal cell carcinoma (RCC) in an adequate and well-controlled trial." On this news, Aveo shares declined another $2.61 per share or nearly 50%, to close at $2.65 per share on May 2, 2013, on volume of over 15 million shares. Plaintiffs seek to recover damages on behalf of all Class members who invested in Aveo securities during the Class Period. If you invested in Aveo securities as described above during the Class Period, and either lost money on the transaction or still hold the stock, you may wish to join in this action to serve as lead plaintiff. In order to do so, you must meet certain requirements set forth in the applicable law and file appropriate papers no later than July 8, 2013. A "lead plaintiff" is a representative party that acts on behalf of other class members in directing the litigation. In order to be appointed lead plaintiff, the court must determine that the class member's claim is typical of the claims of other class members, and that the class member will adequately represent the class. Under certain circumstances, one or more class members may together serve as lead plaintiff. Your ability to share in any recovery is not, however, affected by the decision whether or not to serve as a lead plaintiff. You may retain Bernstein Liebhard LLP, or other counsel of your choice, to serve as your counsel in this action.