INSYS Therapeutics Inc (NASDAQ: INSY), a company that is most well known for its cannabis related therapeutics, is having a great start to the trading session this morning, and for good reason. The company announced that the United States Food and Drug Administration (FDA) has granted one of the company’s investigational treatments with Fast Track Designation. Of course, the news excited investors, sending the stock on a run for the top. Today, we’ll talk about:
- The designation;
- what we’re seeing from INSY as a result; and
- what we’ll be watching for ahead.
INSY Announces Fast Track Designation
As mentioned above, INSYS Therapeutics is having a great start to the trading session in the pre-market hours this morning after the company announced that it has been granted Fast Track Designation. In a press release issued early this morning, the company said that the FDA has granted Fast Track designation to the company’s epinephrine nasal spray.
The epinephrine nasal spray is an investigational treatment being developed to treat anaphylaxis. Anaphylaxis is an acute, life threatening allergic reaction that requires urgent treatment. In a statement, Steve Sherman, Vice President of Regulatory Affairs at INSY, had the following to offer:
The receipt of Fast Track designation represents a significant milestone for INSYS and our clinical development of this novel drug-device combination… We look forward to working with the agency to make it available to those who may be interested in an alternative to intramuscular auto-injectors as soon 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 causes moves. In the case of INSYS, the news proved to be overwhelmingly positive. After all, Fast Track designation will shorten the path to FDA approval. So, it comes as no surprise that excited investors are sending the stock screaming for the top. Of course, our partners at Trade Ideas were the first to alert us to the gains. Currently (8:25), INSY is trading at $8.42 per share after a gain of $0.46 per share or 5.78% 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 INSY. In particular, we’re interested in following the story surrounding the company’s continued work to bring its epinepherine nasal spray to market, a process that will likely be quicker following the Fast Track designation. Nonetheless, we’ll continue to follow the story closely and bring the news to you as it breaks!
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