AVEO Pharmaceuticals, Inc.

Aveo Pharmaceuticals, Inc. Sued by Investor

Robbins Arroyo LLP announces that a purchaser of Aveo Pharmaceutical, Inc. (NASDAQGS: AVEO) securities has filed a complaint in the U.S. District Court for the District of Massachusetts.  The complaint alleges that Aveo and certain of its officers violated the Securities Exchange Act of 1934 (the “Exchange Act”) between January 3, 2012 and May 1, 2013 (the “Class Period”).

Aveo Accused of Making False and Misleading Statements Concerning the Company’s Business Prospects

The complaint alleges that Aveo, a biopharmaceutical company that focuses on discovering, developing, and commercializing cancer therapies, issued a series of materially false and misleading statements to investors regarding the viability of the company’s lead drug Tivopath (or tivozanib).  Specifically, the complaint alleges that the defendants misled investors to believe that Tivopath would receive approval from the U.S. Food and Drug Administration (“FDA”) by touting Tivopath’s Phase III trial design and results.  The complaint accuses the defendants of violations of the Exchange Act by virtue of their failure to disclose during the Class Period that: (i) the FDA had recommended that Aveo conduct an additional Phase 3 trial for Tivopath due to adverse trends in the company’s first Phase III trial; (ii) there was a 25% higher rate of death associated with Tivopath, compared to the control drug, Sorafenib; and (iii) nearly 90% of the patients studied in the company’s Phase III trial were enrolled from sites in Central and Eastern Europe, where treatment patterns were inconsistent with those in the United States.

Aveo Price Drops Multiple Times

On April 30, 2013, the FDA released its Oncologic Drugs Advisory Committee (“ODAC”) briefing document (the “Briefing Document”) that, among other matters, took particular issue with the rigor of Tivopath’s Phase III trial.  The Briefing Document also highlighted the regulatory history of Tivopath, and the fact that Aveo disregarded explicit FDA recommendations that the company conduct an additional Phase III trial.  On this news, Aveo’s stock declined $2.33 per share or over 31%, to close at $5.11 per share on April 30, 2013.

Moreover, on May 2, 2013, the ODAC voted by an overwhelming majority (13 to 1) not to recommend approval of Tivopath, 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.”  As a result, Aveo shares declined a further $2.61 per share or nearly 50%, to close at $2.65 on May 2, 2013.

If you purchased or otherwise acquired Aveo stock during the Class Period and wish to serve as lead plaintiff, you must act no later than July 8, 2013.  To discuss your shareholder rights, please contact attorney Darnell R. Donahue at (800) 350-6003 or you can complete the form below and we will contact you directly.

 

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