AVEO Pharmaceuticals, Inc. (NASDAQ: AVEO) is tumbling in the market this morning. So far, it’s down $0.34, or 37.57%. The declines come following an announcement surrounding a meeting with the FDA that may lead to the company withdrawing its New Drug Application for Tivozanib. Here’s what’s going on:
AVEO Stock Tumbles On FDA Feedback
AVEO Pharmaceuticals issued a press release early this morning, announcing the results of a meeting that it recently had with the FDA. In the meeting, the company and the FDA discussed the results from the TIVO-3 clinical study. The goal was for the FDA to give the company the nod to proceed with the New Drug Application.
Unfortunately, that’s not what happened. In the meeting, the FDA expressed serious concerns about the overall survival trend in the TIVO-1 trial. In fact, the FDA said that inconsistencies in progression free survival and overall survival, combined with an imbalance in post study treatments made the results of the trial uninterpretable and inconclusive. As a result, the FDA can’t propery assess risk vs. benefit.
A big issue with the data from TIVO-3 is the overal survival hazard ratio, which the most recent analysis of data showed that it was 0.99. This high hazard ratio isn’t only causing concerns, it could lead to AVEO withdrawing its application.
In fact, the company and the FDA have agreed that if the final analysis shows an overall survival hazard rate of higher than 1.00, the company will withdraw its NDA application.
In a statement, Michael Baily, President and CEO at AVEO, had the following to offer:
During the meeting with the FDA, we believe that we established an appropriate path forward toward filing an NDA for tivozanib in the near term and a final analysis plan for OS. The continued separation of the PFS curves and the positive trend in OS HR observed from the first to the second interim analysis, together with tenfold more patients remaining progression free and on tivozanib vs. sorafenib therapy, make us believe that the final OS results will not worsen.
This Could Be A Very Big Play
There’s no doubt that if you’re considering an investment in AVEO right now, you’re taking on a big risk. Afterall, if the data shows an OS HR of higher than 1.00 or the company doesn’t address all of the regulatory agency’s concerns, the NDA will be pulled and the stock will likely tank. However, there’s an opportunity for some serious gains here too.
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