NEW YORK, May 18, 2013 /PRNewswire/ -- Faruqi & Faruqi, LLP, a leading national securities law firm, is investigating potential securities fraud at AVEO Pharmaceuticals, Inc. ("AVEO" or the "Company") (NASDAQ: AVEO).
The investigation focuses on whether the Company and its executives violated federal securities laws by issuing materially false and/or misleading statements regarding the Company's Phase III drug trials for Tivopath (tivozanib) (titled "TIVO-1"). Specifically, the investigation focuses on whether the Company failed to disclose that: (1) the FDA had recommended to the Company that it conduct an additional Phase III trial due to adverse trends in the Company's first tivozanib drug study; (2) there was a 25% higher rate of death associated with tivozanib therapy compared to the control drug, sorafenib; and (3) 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 United States.
On April 30, 2013, the FDA released its Oncologic Drugs Advisory Committee ("ODAC") briefing document, highlighting the regulatory history of Tivopath and the fact that the Company disregarded explicit FDA recommendations for the Company to conduct an additional Phase III trial. On this news, the Company's share prices fell $2.33, or 31.31% per share, to close at $5.11 on April 30, 2013.
On May 2, 2013, the ODAC voted 13 to 1 to not recommend approval of the tivozanib, noting "tivozanib 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 $2.61 per share, or nearly 50%, to close at $2.65 per share on May 2, 2013.
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If you invested in AVEO stock or options between January 3, 2012 and May 1, 2013 and would like to discuss your legal rights, visit www.faruqilaw.com/AVEO. You can also contact us by calling Richard Gonnello or Francis McConville toll free at 877-247-4292 or at 212-983-9330 or by sending an e-mail to email@example.com or firstname.lastname@example.org. Faruqi & Faruqi, LLP also encourages anyone with information regarding AVEO's conduct to contact the firm, including whistleblowers, former employees, shareholders and others.
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