According to the law firm press release, Aveo is a biopharmaceutical company focused on discovering, developing, and commercializing cancer therapeutics. 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: (a) the Company failed to disclose to investors that the FDA had recommended to the Company to conduct an additional Phase III trial due to adverse trends in the Company's first study; (b) the Company misled investors regarding the overall safety and efficacy of the product, including failure to disclose the 25% higher rate of death associated with tivozanib therapy compared to the control drug, sorafenib; (c) the Company 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 US. 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 matters, 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 for the Company to conduct an additional Phase III trial, "[a] pre-NDA meeting was held in May 2012. Here, the FDA expressed concern about the adverse trend in overall survival in the single Phase 3 trial ("TIVO-1") and recommended that the sponsor [Aveo] conduct a second adequately powered randomized trial in a population comparable to that in the US. "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) to not recommend approval of the tivozanib, because, "the application for investigational agent 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, on volume of over 15 million shares.
On December 3, 2013, there was an Order Consolidating Related Actions. The Court appointed Lead Plaintiffs, retained Pomerantz Grossman Hufford Dahlstrom & Gross LLP to serve as Lead Counsel and Shapiro Haber & Urmy LLP as Local Counsel in this action.
Lead Plaintiffs filed a consolidated complaint on February 3, 2014.
This case was dismissed by the Court on November 18, 2015. Plaintiffs filed a Notice of Appeal of this decision on December 9.
On January 3, 2017, the Court issued an Order granting Plaintiffs' motion to vacate the dismissal and judgment entered against them.