BioCryst Pharmaceuticals, Inc. (NASDAQ: BCRX) is having a great start to the trading session this morning after the company announced that its candidate has been granted Fast Track Designation by the FDA. Of course, the news excited investors, sending the stock on a run for the sky. Today, we’ll talk about:
- The designation;
- what we’re seeing from BCRX stock as a result; and
- what we’ll be watching for ahead.
BCRX Announces Fast Track Designation
As mentioned above, BioCryst Pharmaceuticals is having a strong start to the trading session as news breaks surrounding Fast Track Designation. In a press release issued early this morning, the company announced that it has been granted Fast Track Designation by the United States Food and Drug Administration (FDA). The designation surrounds BCX7353, a treatment that is being developed for the prevention of angioedema attacks in patients with hereditary angioedema (HAE).
The Fast Track Designation provided to BCRX means that the company will have more frequent conversations with the FDA and further support in the development of the product. Als, the company will enjoy a priority review should the strenghts of the treatment be supported by clinical data at the time of the new drug application. In a statement, Jon P. Stonehouse, President and CEO at BCRX, had the following to offer:
Fast Track Designation from the FDA serves as another indicator of the importance of BCX7353 to meet an unmet medical need for HAE patients in the U.S… We remain focused on completing the Phase 3 program and preparing for an NDA filing in the second half of 2019.
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 BioCryst Pharmaceuticals, the news proved to be overwhelmingly positive. After all, Fast Track Designation will likely reduce the time it takes for the company to achieve FDA approval for BCX7353. So, it comes as no surprise that excited investors are sending the stock upward in the market this morning. Of course, our partners at Trade Ideas were the first to alert us to the gains. Currently (8:58), BCRX is trading at $5.80 per share after a gain of $6.10 per share or 5.17% 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 BCRX. In particular, we’re interested in following the continued development of BCX7353 and excited to see the progress considering the Fast Track Designation that was announced today. Nonetheless, we’ll continue to follow the story closely and bring the news to you as it breaks!