Clovis Oncology Inc (NASDAQ: CLVS) is having an incredibly strong start to the trading session this morning, and for good reason. The company’s flagship candidate has been granted Breakthrough Therapy designation by the FDA. Of course, the news excited investors, sending the stock screaming for the top. Today, we’ll talk about:
- The designation;
- what we’re seeing from CLVS stock as a result; and
- what we’ll be watching for ahead.
CLVS Climbs On Breakthrough Therapy Designation
As mentioned above, Clovis Oncology is having an incredibly strong start to the trading session this morning after announcing that it has received Breakthrough Therapy designation. In a press release issued early this morning, the comapny announced that the Food and Drug Administration (FDA) has granted Breakthrough Therapy designation for Rubraca® (rucaparib). The designation is for the treatment as a monotherapy treatment of adult patients with BRCA1/2-mutated mCRPC who have received at least one prior androgen receptor (AR)-directed therapy and taxane-based therapy.
The breakthrough therapy designation is incredibly important to CLVS. The designation is only given to drugs intended to treat a serious or life-threatening disease or condition whose preliminary evidence may demonstrate a substantial improvement on at least one clinically significant endpoint. As a result, treatments with this designation tend to make it through development faster with further assistance from the FDA.
In a statement, Patrick, J. Mahaffy, President and CEO at CLVS, had the following to offer:
We are committed to the rapid development of Rubraca in mCRPC and we are obviously pleased to receive Breakthrough Therapy designation. We look forward to presenting the data that served as the basis of our BTD application at the ESMO conference later this month… We hope the decision by the FDA to grant this Breakthrough Therapy designation for Rubraca offers encouragement to the prostate cancer community, and we will do our best to make Rubraca available to eligible prostate cancer patients as quickly as possible.
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 leads to moves. In the case of Clovis Oncology, the news proved to be overwhelmingly positive. After all, due to the Breakthrough Therapy designation, Rubraca has a better chance of making it to market and the process is a far faster one. So, it comes as no surprise that excited investors are sending the stock on a run for the top. As is normally the case, our partners at Trade Ideas were the first to alert us to the gains. Currently (9:02), CLVS is trading at $32.00 per share after a gain of $2.86 per share or 9.81% 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 CLVS. In particular, we’re interested in following the story surrounding the company’s continued work to bring Rubraca to market as the Breakthrough Therapy designation will shorten the path to commercialization. Nonetheless, we’ll continue to follow the story closely and bring the news to you as it breaks!
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