On Monday, Shares of AVEO Pharmaceuticals, Inc. (NASDAQ:AVEO), gained 0.81% to $1.24.
AVEO Oncology, stated financial results for the third quarter ended September 30, 2015 and offered a business update.
“We accomplished partnerships for two of AVEO’s lead programs in the third quarter in addition to making progress toward our projected plans to submit a European Marketing Authorization Application (MAA) for tivozanib in renal cancer and initiate a pivotal study in this indication in the U.S.,” said Michael Bailey, president and chief executive officer. “As we work through recently initiated negotiations with the SEC, we remain focused on executing against our aims through the balance of the year, counting exploring potential partnership opportunities for tivozanib in Europe, while maintaining our very lean organization.”
Preceding to the submission of an MAA filing with the European Medicines Agency, the Company is seeking to complete a partnership agreement for tivozanib in Europe. If a partnership is accomplished, in order to provide a potential partner with the opportunity to submit the application on its own behalf, AVEO now anticipates that a submission would take place in the first quarter of 2016. Furthermore, assuming the availability of financial resources from this or other activities, the Company also now anticipates to initiate its Phase 3 U.S. pivotal study of tivozanib in patients with renal cancer early in the first quarter of 2016.
AVEO also declared that the staff of the Securities and Exchange Commission and the Company recently reached negotiations for the settlement of potential claims that the Commission may bring against the Company asserting that the Company formerly violated federal securities laws by omitting to disclose to investors a recommendation made to the Company by the U.S. Food and Drug Administration in May 2012. While the Company has commenced such negotiations, it cannot predict their outcome, nor can it provide assurance that the Company will be able to resolve any potential claims of the Commission or that any potential settlement will not have a material adverse impact on the Company’s projected plans or its financial position or results of operations.
AVEO Pharmaceuticals, Inc., a biopharmaceutical company, develops targeted therapies for patients with cancer and related diseases. Its product candidates under development comprise Tivozanib, an tyrosine kinase inhibitor for various vascular endothelial growth factors; Ficlatuzumab, a hepatocyte growth factor inhibitory antibody, which has accomplished Phase II trial; and AV-203, an anti-ErbB3 monoclonal antibody that has accomplished a Phase I dose escalation study.
Shares of Endo International plc (NASDAQ:ENDP), declined -1.45% to $54.50, during its last trading session.
Endo International plc, declared that it has offered an informational Frequently Asked Questions & Answers (Q&A) document designed for investors to learn more about the Company.
Endo International plc, a specialty healthcare company, focuses on branded and generic pharmaceuticals and devices worldwide. It operates through four segments: U.S. Branded Pharmaceuticals, U.S. Generic Pharmaceuticals, Devices, and International Pharmaceuticals.
Finally, Shares of Reynolds American, Inc. (NYSE:RAI), ended its last trade with -0.10% loss, and closed at $44.58.
Reynolds American, has declared the following: “RAI recommends shareholders reject ‘mini-tender’ offer by TRC Capital Corporation.”
Reynolds American Inc., through its auxiliaries, manufactures and sells cigarettes and other tobacco products in the United States. It operates through RJR Tobacco, American Snuff, and Santa Fe segments. The RJR Tobacco segment offers cigarettes under the brand names of CAMEL, PALL MALL, WINSTON, KOOL, DORAL, SALEM, MISTY, and CAPRI; and CAMEL Snus, a smoke-free tobacco product, in addition to manages various licensed brands, counting DUNHILL and STATE EXPRESS 555.