AVEO Oncology (NASDAQ: AVEO) shares soared over 80% this morning on news that FOTIVDA™ has been recommended for approval as a treatment for patients with advanced renal cell carcinoma (RCC) by the Committee for Medicinal Products for Human Use (CHMP), the scientific committee of the European Medicines Agency. The CHMP’s recommendation is referred to the European Commission, which is anticipated to make its final decision in approximately 67 days. Approval of FOTIVDA™ would also result in R&D reimbursement and milestone payments for the company. “If the European Commission grants marketing approval for tivozanib, it would trigger a $4 million research and development reimbursement payment from EUSA, and AVEO will also be eligible for up to $12 million in additional milestones from EUSA based on member state reimbursement and regulatory approvals. These payments would add significant resources to our balance sheet as we work toward the anticipated readout of our U.S. pivotal trial in third-line RCC, the TIVO-3 trial, in the first quarter of 2018,” AVEO president and chief executive officer Michael Bailey stated in the news release.
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AVEO Oncology (AVEO) is a biopharmaceutical company dedicated to advancing a broad portfolio of targeted therapeutics for oncology and other areas of unmet medical need. The company is focused on seeking to develop and commercialize its lead candidate tivozanib, a potent, selective, long half-life inhibitor of vascular endothelial growth factor 1, 2 and 3 receptors, in North America as a treatment for renal cell carcinoma. AVEO is leveraging multiple partnerships aimed at developing and commercializing tivozanib in oncology indications outside of North America, and at progressing its pipeline of novel therapeutic candidates in cancer, cachexia (wasting syndrome) and Pulmonary Arterial Hypertension (PAH). For more information, please visit the company’s website at www.aveooncology.com.
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