Portola Pharmaceuticals Inc (NASDAQ: PTLA) is having a great start to the trading session this morning, and for good reason. The company announced that the European Medicines Agency’s committee had a positive opinion with regard to its drug.
Of course, the news is proving exciting to investors, who are sending the stock up. Today, we’ll talk about:
- The news;
- what we’re seeing from PTLA stock as a result; and
- what we’ll be watching for ahead.
PTLA Announces CHMP News
As mentioned above Portola Pharmaceuticals is having a great day in the market today after the company announced positive regulatory news. The news surrounded the opinion of the Committee for Medical Products for uman Use (CHMP) of the European Medicines Agency (EMA).
In a press release issued early this morning, PTLA said that the EMA has adopted a positive opinion on the marketing authorization application for Ondexxya. As a result of this positive opinion, the CHMB has recommended that the European Commission grant Ondexxya conditional approval for the reversal of the anticoagualt effects of the Factor Xa inhibitors apixaban or Rivaroxaban. The treatment is indicated for patients experiencing uncontrolled or life-threatening bleeding.
The next step is for the European Commission to review the MMA. Sould all go well, Ondexxya would be the first and only specific reversal agent available in Europe to address life threatening bleeding associated with the use of apixaban or rivaroxaban. It is expected that the Commission’s decision will come in May.
In a statement, Jan Beyer-Westendorf, M.D., Head of the Thrombosis Research Unit, Department of Medicine at the Division Hematology, University Hospital Dresden, German, had the following to offer with regard to the PTLA news:
Today’s positive CHMP opinion represents a significant step forward in patient care and in the ability of clinicians to address life-threatening bleeds associated with the use of Factor Xa inhibitors. Given the number of patients currently taking Factor Xa inhibitors and the anticipated growth of their utilization in Europe, the medical community has been eagerly awaiting the availability of an antidote that, in case of emergencies, can rapidly reverse the anticoagulating effects of rivaroxaban or apixaban. The European Society of Cardiology has already recognized the potential role of andexanet alfa, and we look forward to the potential approval and availability of this important medicine.
What We’re Seeing From The Stock
One of the first lessons that we learn when we start to work in the market is that the news leads to moves. When it comes to Portola Pharmaceuticals, the news proved to be positive. After all, if their treatment is approved in Europe, it will open the door to a stream of revenue.
So, it’s not surprising to see that excited investors are sending the stock up in the market this morning. As is just about always the case, our partners at Trade Ideas were the first to alert us to the gains. Currently (9:14), PTLA is trading at $34.00 per share after a gain of $3.29 per share or 10.71% 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 PTLA. In particular, we’re interested in following the story surrounding the company’s continued work to bring Ondexxya to market. Nonettheless, we’ll keep a close eye on the news and bring it to you as it breaks!
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