AVEO Pharmaceuticals, Inc. (NASDAQ: AVEO) is having a pretty strong start to the trading session this morning, and for good reason. The company announced that it has received approval from the European Commission with regard to its treatment for renal cell carcinoma. Of course, this news led to excitement among investors, prompting gains in the value of the stock as excited investors buy up more shares. At the moment (9:58), AVEO is trading at $3.91 per share after a gain of $0.11 per share or 2.97% thus far today.
AVEO Announces European Approval Of FOTIVDA®
As mentioned above, AVEO Pharmaceuticals announced today that the European Commission has approved FOTIVDA® (tivozanib) for the treatment of adult patients with renal cell carcinoma. As a result, the treatment will be available in the European Union as weel as Norway and Iceland. EUSA Pharma, a specialty pharmaceutical company focused on oncology and oncology supportive care has licensed the treatment for commercialization in these areas. In a statement, Dr. Bernard Escudier, Medical Oncologist and member of the Genitourinary Tumor Board of Gustave Roussy, France, had the following to offer about the AVEO news…
“This is excellent news for patients with metastatic RCC. Outcomes in this disease have greatly improved with the introduction of targeted therapies, meaning that patients are living for longer. However, we are still in need of effective and well tolerated new treatments in metastatic RCC and thus, tivozanib is a welcomed addition.”
This statement was followed up by Michael Bailey, President and CEO at AVEO…
“The European Commission’s decision in the first regulatory approval of tivozanib globally, and a tremendous accomplishment for AVEO and its partner, EUSA Pharma, We are very pleased that tivozanib is now available to patients in Europe… We also continue to make progress on the next two pillars in our tivozanib strategy: U.S. registration, driven by the pivotal Phase 3 TIVO-3 trial, which is expected to read out in the first quarter of 2018; and immunotherapy combination trials, starting with the TiNivo trial, our Opdivo® combination trial. European approval further strengthens our balance sheet by triggering an R&D payment to AVEO and provides AVEO the opportunity to achieve multiple potential commercial milestone payments, as well as royalty payments on sales, that would support our execution of the tivozanib strategy.”
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What We’ll Be Watching For Ahead
Moving forward, the CNA Finance team will continue to keep a close eye on AVEO. In particular, we’re interested in following the company’s ongoing work to bring tivozanib to the United States market. Considering the EU approval, chances of this happening are getting better and better with each passing day. We’re also interested in following the ongoing work surrounding Opdivo. Nonetheless, we’ll continue to follow the story closely and bring the news to you as it breaks!
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