AVEO Pharmaceuticals, Inc.
- Company Name
- AVEO Pharmaceuticals, Inc.
- Stock Symbol
- Class Period
- August 4, 2016 to January 31, 2019
- Motion Deadline
- April 26, 2019
- Southern District of New York
The complaint charges AVEO and certain of its officers with violations of the Securities Exchange Act of 1934. AVEO is a biopharmaceutical company that develops and commercializes a portfolio of targeted oncology drugs and drugs for the treatment of unmet medical needs. AVEO was formerly known as GenPath Pharmaceuticals, Inc., but changed its name to AVEO Pharmaceuticals, Inc. in March 2005.
AVEO’s lead drug candidate is tivozanib (FOTIVDA), an oral once-daily medication for the treatment of renal cell carcinoma (“RCC”). In June 2013, tivozanib was deemed insufficient for approval by the U.S. Food & Drug Administration (“FDA”) because of reported concerns regarding the negative trend in overall survival in the Company’s first pivotal Phase 3 trial (the “TIVO-1 trial”). On May 26, 2016, AVEO announced the dosing of its first patient in its Phase 3 randomized controlled multi-center open-label study to compare tivozanib to sorafenib in 351 subjects with highly refractory advanced or metastatic RCC (the “TIVO-3 trial”). According to AVEO, the TIVO-3 trial was designed to address the overall survival concerns from the TIVO-1 trial presented in June 2013.
The complaint alleges that throughout the Class Period, defendants made materially false and misleading statements and/or failed to disclose adverse information regarding the Company’s business and the prospects for FDA approval of tivozanib. Specifically, defendants failed to disclose that the TIVO-3 trial was not adequately designed to allay concerns about the negative trend in overall survival from the TIVO-1 trial presented in June 2013, and tivozanib had insufficient survival data to obtain FDA approval after its initial rejection in 2013, which would put tivozanib at greater risk of delayed FDA approval. As a result of this and other information being withheld from the market, AVEO securities traded at artificially inflated prices, with the Company’s shares reaching a high of $4 per share.
On November 5, 2018, AVEO issued a press release announcing that tivozanib had successfully “met its primary endpoint of demonstrating a statistically significant benefit in progression-free survival” through the TIVO-3 trial. According to the press release, AVEO planned to submit a New Drug Application (“NDA”) for tivozanib to the FDA in approximately six months based on results from the TIVO-3 trial and the previously completed TIVO-1 trial of the drug for the treatment of RCC.
Then on January 31, 2019, the Boston Business Journal reported that AVEO would not submit its NDA for FDA approval of tivozanib due to a recommendation from the agency to gather more late-stage testing results. Specifically, the FDA was asking for “additional survival data, echoing concerns that led to the agency’s rejection of the same drug in 2013.” On this news, the price of AVEO stock dropped $1.07 per share, or over 60%, to close at $0.70 per share on January 31, 2019.