Puma Biotechnology Inc (NASDAQ: PBYI) is having an overwhelmingly strong start to the trading session this morning after announcing a regulatory update surrounding its treatment for early stage HER2-positive hormone receptor positive breast cacner. Of course, the update was positive, leading to excitement among investors and sending the stock screaming for the top. 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 Provides 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 the Committee for Medical Products for Human Use (CHMP) of the European Medicines Agency (EMA) has adopted a positive trend vote. In the vote, the CHMP ultimately recommends the approval fo the Marketing Authorization Application (MAA) for neratinib.
Neratinib is a treatment developed by PBYI for the extended adjuvant treatment of early stage HER2-positive hormone receptor positive breast cancer. The decision to vote in favor of approval of the treatment follows a reexamination of the negative opinion that was announced by the CHMP at its formal meeting with the company back on February 23, 2018. In the release, PBYI said that the CHMP intends to hold a final vote at its next meeting.
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 Puma Biotechnology, the news proved to be overwhelmingly positive. With a trend toward the CHMP voting for the approval of neratinib, the chances of the drug making it to market in Europe relatively soon are pretty high. So it’s no surprise that excited investors are pushing the stock on a run for the top. Of course, our partners at Trade Ideas were the first to alert us to the gains. At the moment (10:27), PBYI is trading at $58.80 per share after a gain of $7.70 per share or 15.07% thus far today,.
Stop wasting your time! Start finding winning trades in minutes with Trade Ideas!
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 neratinib to market in Europe. With the news today, chances of this taking place are looking pretty good. Nonetheless, we’ll continue to follow the story closely and bring the news to you as it breaks!
Never Miss The News Again
Do you want real-time, actionable news delivered to your inbox? Join the CNA Finance mailing list below!