Puma Biotechnology Inc (NASDAQ: PBYI) is having a relatively strong start to the trading session this morning, and for good reason. The company announced a regulatory update that brings its product one step closer to approval in Europe. Of course, the news excited investors who are sending the stock toward the top this morning. Today, we’ll talk about:
- The regulatory update;
- what we’re seeing from PBYI as a result; and
- what we’ll be watching for ahead.
PBYI Announces Regulatory Update
As mentioned above, Puma Biotechnology is having an incredibly strong start to the trading session this morning after providing a regulatory update. In a press release issued early this morning, the company announced that on June 28, 2018, the Committee for Medical Products for Human Use, or CHMP, has adopted a positive opinion with regard to the recommendation of NERLYNX® (neratinib).
NERLYNX is currently being developed by PBYI for the extended adjuvant treatment fo adults with early stage hormone receptor positive HER2-overexperessed/amplified breast cancer and who are less than one year from the completion of prior adjuvant trastuzumab based therapy. In the release, PBYI said that the CHMP recommendation will be reviewed by the European Commission, the commission that has the authority to approve medicines in the European Union.
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 PBYI, the news proved to be overwhelmingly positive. After all, a positive vote from the CHMP means that the company’s chances of EU regulatory approval are now very strong. So, it’s no surprise to see that excited investors are reacting by pushing the stock upward in the market this morning. Of course, our partners at Trade Ideas were the first to alert us to the gains. At the moment (8:10), PBYI is trading at $58.30 per share after a gain of $1.95 per share or 3.46% 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 PBYI. In particular, we’re interested in following the story surrounding the company’s continued work to bring NERLYNX to market in the EU as the process is looking pretty promising at the moment. Nonetheless, we’ll continue to follow the story closely and bring the news to you as it breaks!
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