AVEO Pharmaceuticals, Inc. (NASDAQ:AVEO) Scores A Big Win In Europe

At the beginning of June, we highlighted AVEO Pharmaceuticals, Inc. (NASDAQ:AVEO) as being a company to keep an eye on as part of this piece. At the time, AVEO was heading into a key regulatory decision, and we suggested that – if the decision went the company's way –there could be plenty of upside potential on offer as and when it hit press.On Friday, we got the news we were looking for and – as it turned out – we got the outcome we were looking for as well.Mid last week, AVEO traded for around $0.70 a share. By the session close on Friday, this had risen to $1.25 a share. Premarket on Monday, the company gained a further 12%, and will open in and around $1.39 a piece. From the price at which AVEO traded when we first highlighted it, $0.75 a share, that's an 85% gain in a matter of weeks and another big win for our Biotech Catalysts series.Congratulations to our readers that took a position on the back of our initially highlighting this one.So how did it all play out?The update comes on the back of a meeting of what's called the Committee for Medicinal Products for Human Use (CHMP), which is sort of a European alternative to the various committees that the US Food and Drug Administration (FDA) sets up to make a recommendation on a development stage asset.Just as these committees get together in the US and vote on whether a drug is approvable in its current application format, the CHMP gets together and does the same in Europe, subsequently making a recommendation to the European Medicines Agency (EMA), which is the European equivalent of the FDA, as to the approvability of a particular asset, and ultimately, the EC.In this instance, the asset in question is tivozanib and the application is an attempt to get the drug approved in a target indication of the treatment of patients with advanced renal cell carcinoma (RCC), which is a form of kidney cancer. It's a dramatic unmet need in Europe and the US right now, easily in the top five deadliest cancers globally, and the space is crying out for fresh alternative treatments for patients both naïve to treatment and that have undergone some form of treatment in the past and have either failed to respond to it or are no longer responding to it as they once did.The latest decision in Europe supports a first-line indication, meaning many patients could potentially be treated with tivozanib before any other therapy on the market, and also supports the drug as a treatment for adult patients with advanced kidney cancer who meet certain criteria and have received one prior treatment with cytokine therapy.This recommendation is a big win for AVEO, and sets the company up for a near-term regulatory green light on the asset in Europe. The company expects to hear back from the EC, which is the entity that's going to have the final say on this one, within a very specific 67 days.There is also a near-term US catalyst based on the same asset for AVEO. The company is attempting to replicate the same success on the other side of the Atlantic and, to that aim, is conducting a trial that pitches tivozanib against sorafenib, an already approved Bayer AG (ADR)(OTCMKTS:BAYRY) asset. Data from this study is set to read out during the first quarter of 2018, meaning we should get the European decision a while before we get any concrete indication of whether the drug is set to pick up approval in the US. If the European decision looks good, expect some loading up ahead of the European readout.We're going to keep an eye on this development pathway as it matures, and we expect markets to continue loading up on AVEO ahead of the final European decision and, beyond that, the phase 3 readout in the US.Don't miss out on our next Biotechnology Catalyst play. Subscribe below and we'll keep you in the loop!We will be updating our subscribers as soon as we know more. For the latest updates on AVEO, sign up below!Image courtesy of e_Life via FlickrDisclosure: We have no position in AVEO and have not been compensated for this article.