AVEO Pharmaceuticals, Inc. (NASDAQ:AVEO) is coming off a tough 2016, but the company is making up for it this summer with +180% gains off recent news. The company’s drug is struggling to get FDA approvals, but could see approval in Europe (mostly in the bag already – details below). AVEO is still continuing to work toward FDA approval, but Europe is a large market and traders are reacting.
The drug, tivozanib, is being licensed in Europe by EUSA Pharma Inc. Tivozanib is intended for advanced renal cell carcinoma, which is the most common type of kidney cancer and is anticipated to be one of the fastest growing cancers in the next decade. AVEO failed to receive Food and Drug Administration approval for tivozanib back in 2013. The company has an ongoing phase 3 trial in third-line renal cell carcinoma, which is expected to read out in the first quarter of 2018. European approval of tivozanib would “add significant resources to our balance sheet as we work toward the anticipated readout,” AVEO Chief Executive Michael Bailey said (full quote below), including a $4 million research and development reimbursement payment and up to $12 million in additional milestone payments from EUSA Pharma.
AVEO Pharmaceuticals, Inc. (NASDAQ:AVEO) is a biopharmaceutical company dedicated to advancing a broad portfolio of targeted therapeutics for oncology and other areas of unmet medical need. AVEO is leveraging multiple partnerships aimed at developing and commercializing tivozanib in oncology indications outside of North America (mentioned above), and progressing its pipeline of novel therapeutic candidates in cancer, cachexia (wasting syndrome) and Pulmonary Arterial Hypertension (PAH).
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Michael Bailey, president and chief executive officer of AVEO gave this quote after the company’s good news: “A positive opinion from the CHMP is a critical step in our goal of obtaining regulatory approval of tivozanib as a treatment for RCC. Tivozanib’s unique tolerability profile together with the longest progression free survival reported in a Phase 3 first line RCC study, have the potential to fill an unmet patient need for better tolerated treatment in this disease. 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 Pharmaceuticals, Inc. (NASDAQ:AVEO) still have a chance for tivozanib to be approved here, but the company will probably need more operating cash. The company’s stock price has dwindled from 2012-2013, but there is still value here since the drug is tackling a fast-moving cancer. AVEO is on our radar and we will be reading the tea leaves for important test results here in the States. For continuing coverage on shares of Aveo’s stock, as well as our other breakout stocks, sign up for our free newsletter today and get our next hot stock pick!