Pomerantz LLP announces that a class action lawsuit has been filed against Aveo Pharmaceuticals, Inc. (“Aveo” or the “Company”) (NASDAQ: AVEO) and certain of its officers and directors. The class action, filed in United States District Court, Southern District of New York, and indexed under 19-cv-01722, is on behalf of a class consisting of all persons and entities, other than Defendants and their affiliates, who purchased or otherwise acquired AVEO securities between August 4, 2016 through January 31, 2019, both dates inclusive (the “Class Period”), seeking to recover damages caused by Defendants’ violations of the federal securities laws and to pursue remedies under Sections 10(b) and 20(a) of the Securities Exchange Act of 1934 (the “Exchange Act”) and Rule 10b-5 promulgated thereunder, against the Company and certain of its top officials.
If you are a shareholder who purchased Aveo securities during the class period, you have until April 26, 2019, to ask the Court to appoint you as Lead Plaintiff for the class. A copy of the Complaint can be obtained at www.pomerantzlaw.com. To discuss this action, contact Robert S. Willoughby at firstname.lastname@example.org or 888.476.6529 (or 888.4-POMLAW), toll-free, Ext. 9980. Those who inquire by e-mail are encouraged to include their mailing address, telephone number, and the number of shares purchased.
AVEO is a biopharmaceutical company incorporated in 2001. The Company is based in Cambridge, Massachusetts and develops and commercializes a portfolio of targeted medicines for oncology and other areas of unmet medical need. AVEO was formerly known as “GenPath Pharmaceuticals, Inc.” and changed its name to “AVEO Pharmaceuticals, Inc.” in March 2005.
AVEO markets and develops its lead candidate drug, tivozanib (registered under the trademarked name FOTIVDA), which is an oral, once-daily medication for treating renal cell carcinoma (“RCC”). In June 2013, tivozanib, was deemed insufficient for approval by the U.S. Food & Drug Administration (“FDA”), over reported concerns regarding the negative trend in overall survival (“OS”) in the Company’s first pivotal phase 3 trial (the “TIVO-1” study).
On May 26, 2016, AVEO announced the dosing of its first patient in the “TIVO-3 trial,” the Company’s Phase 3 randomized, controlled, multi-center, open-label study to compare tivozanib to sorafenib in 351 subjects with highly refractory advanced or metastatic. According to AVEO, the TIVO-3 trial was designed to address the overall survival concerns from the TIVO-1 trial presented in June 2013.
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 (PFS)” through the TIVO-3 trial (the “November 5 Press Release”). According to the November 5 Press Release, AVEO planned to submit a New Drug Application (“NDA”) to the FDA in approximately six months based on results from the TIVO-3 trial, together with the previously completed Phase 3 TIVO-1 trial of tivozanib in the first line treatment of RCC.
The complaint alleges that throughout the Class Period, Defendants made materially false and misleading statements regarding the Company’s business, operational and compliance policies. Specifically, Defendants made false and/or misleading statements and/or failed to disclose that: (i) the TIVO‑3 trial was inadequately designed to address the OS concerns regarding AVEO’s lead candidate drug, tivozanib, from the TIVO-1 trial presented in the June 2013; (ii) tivozanib had insufficient survival data to meet FDA approval following its initial 2013 rejection; (iii) this lack of sufficient survival data would put tivozanib at greater risk of delayed FDA approval; and (iv) as a result, AVEO’s public statements were materially false and misleading at all relevant times.
On January 31, 2019, Boston Business Journal reported that AVEO would not submit its tivozanib application for FDA approval “due to a recommendation from the agency gather more late-stage testing results. Specifically, the FDA is asking for additional survival data, echoing concerns that led to the agency’s rejection of the same drug in 2013.”
On this news, AVEO’s stock price dropped $1.07 per share, or over 60%, to close at $0.70 per share on January 31, 2019.