AVEO Pharmaceuticals AVEO Stock News

AVEO Pharmaceuticals, Inc. (NASDAQ: AVEO) is making a run for the top in the pre-market hours this morning, trading on gains of nearly 30% early on. The gains come after the company provided data from a Phase 3 trial. Here’s what’s going on:

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AVEO Stock Gains On Positive Phase 3 Results

In a press release issued early this morning, AVEO provided results from the second prespecified analysis of overal survival in a Phase 3 trial, known as TIVO-3. The trial was designed to compare FOTIVDA (tivozanib) to sorafenib in 350 patients with highly refractory metastatic renal cell carcinoma.

In the release, the company said that the results include an OS (overall survival) hazard ratio of below 1.00, favoring FOTIVDA. This is key as it shows a very low risk of death for the entirety of the data set.

It is concluded that the trial came back with a very positive result. In fact, this is the first ever positive Phase 3 study in third and fourth line RCC. The study is also the first Phase 3 trial in RCC to investigate a predefined subpopulation of patients who received prior immunotherapy.

The data cutoff date came two years from the last patient enrollment date and ten months from the data cut-off date for the first analysis.

In the release, AVEO said that between the two cut-off dates, 16 additional overal survival events were reported on the FOTIVDA arm with 28 reported in the sorafenib arm. Importantly, the company said that 20 patients on the FOTIVDA arm remain progression free. On the sorafenib arm, only 2 patients were still progression free at the cut-off date.

This adds to data that was reported earlier, suggesting that FOTIVDA is highly effective. Let’s not forget that the trial did meet its primary endpoint and the drug proved to be safe and well-tolerated.

Moving forward, the company said that it will discuss these results with the FDA. The goal of these discussions is to find the right path forward for the drug to be approved as an option for patients with RCC.

Discussions with the FDA are expected to take place int he fourth quarter. Following the discussions, the company said that it would update investors with regard to the potential submission of a New Drug Application for FOTIVDA in RCC.

In a statement, Michael Bailey, President and CEO at AVEO, had the following to offer:

We are pleased to see that the positive PFS and ORR outcomes from TIVO-3 have translated into an improved OS hazard ratio. On behalf of the entire AVEO team, we once again offer our sincerest thanks to the patients, caregivers and investigators for participating in this study. AVEO remains committed to improving outcomes for patients with RCC, and we look forward to discussing these results with the FDA.

This News Should Not Be Ignored

The news issued by AVEO this moring was overwhelmingly positive for the company and its investors. First and foremost, continued positive data showing that the company’s candidate is performing better than the current standard of care only helps to support the potential regulatory approval of the drug.

Nonetheless, it’s not just the high likelihood of approval that investors are excited about here, it’s the massive market size that the company will be tapping into if approved. By the year 2022, experts suggest that the kidney cancer market will grow to be worth a whopping $6.3 billion per year.

Keep in mind, AVEO is a clinical-stage biotechnology company. It has no drugs on the market and is unable to generate revenue from the sale of its treatment candidates. As a result, the stock is a penny stock, trading with a market cap around $100 million.

Think about the potential opportunity that would come of a $100 million company tapping into a $6.3 billion market. The company would only need to access a very small portion of a market of this size to produce meaningful value for investors. Considering the strong data, it shouldn’t be very difficult to penetrate this market.

All in all, the data released today doesn’t just support a potential new drug approval for AVEO, it does so in an indication that could take the company from clinical-stage oncology to commercial stage oncology with a blockbuster treatment! All in all, this opportunity is hard to ignore!

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