Verastem Inc (NASDAQ: VSTM) is having a relatively strong start to the trading session this morning, and for good reason. The company announced that the FDA has approved its New Drug Application for COPIKTRA™. Of course, the approval excited investors who are pushing the stock up in the market as we speak. Today, we’ll talk about:
- The approval;
- what we’re seeing from VSTM stock as a result; and
- what we’ll be watching for aehad.
VSTM Announces FDA Approval
As mentioned above, Verastem is having a strong start to the trading session this morning after the company announced an FDA approval. In a press release issued early this morning, the company said that the US FDA has approved COPIKTRA.
COPIKTRA is an oral inhibitor of phosphoinositide 3-kinase (PI3K). It is also the first approved dual inhibitor of PI3K-delta and PI3K-gamma. VSTM designed the treatment for adults with various cancers. The approval is specific to relapsed or refractory chronic lyphocytic leukemia/small lymphocytic lymphoma (CLL/SLL). The approval also dictates that the treatment is indicated for patients that have received two prior lines of therapy.
In the release, the company said that COPIKTRA was also approved for the treatment of adult patients with relapsed or refractory follicular lymphoma (FL) after at least two prior systemic therapies. This particular indication was approved under accelerated approval based on response rate. However, for continued approval in this indication, the company must maintain positive data through confirmatory trials.
In a statement, Robert Forrester, President and CEO at VSTM, had the following to offer:
With today’s FDA approval of COPIKTRA, Verastem Oncology is delivering upon our commitment to patients with cancer by bringing a new oral medicine to market… We are pleased to be able to introduce COPIKTRA during National Blood Cancer Awareness Month. At Verastem Oncology, we are driven by the strength and courage of those battling cancer, and we are committed to advancing therapies such as COPIKTRA with the potential to make a significant impact for patients, their caregivers and physicians. We are immensely grateful to the many patients who participated in the duvelisib clinical trial program over the years leading to this pivotal moment.
What We’re Seeing From The Stock
One of the first lessons that we learn when we start to dig into the market is that the news causes moves. In the case of Verastem, the news proved to be overwhelmingly positive. After all, an FDA approval means that the company can now commercialize its COPIKTRA treatment. So, it comes as no surprise that excited investors are pushing the stock up in the market this morning. As is normally the case, our partners at Trade Ideas were the first to alert us to the gains. Currently (8:00), VSTM is trading at $9.25 per share after a gain of $0.31 per share or 3.52% thus far today.
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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 VSTM. In particular, we’re excited to watch as the company pushes COPIKTRA into commercialization. Nonetheless, we’ll continue to follow the story closely and bring the news to you as it breaks!
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