Heron Therapeutics Inc (NASDAQ: HRTX) is flying early on in the market this morning, and for good reason. Not only did the company report positive data from multiple clinical studies, it also announced positive feedback from the FDA, leading to Breakthrough Therapy Designation. Of course, the news proved to excite investors, sending HRTX on a run for the top. Today, we’ll talk about:
- The clinical update;
- what we’re seeing from HRTX as a result;
- and what we’ll be watching for ahead.
HRTX Releases Clinical And Regulatory News
As mentioned above, Heron Therapeutics is having an incredibly strong start to the trading session this morning after the company announced results from two clinical trials as well as the receipt of Breakthrough Therapy Designation from the United States Food and Drug Administration (FDA). In the first press release, the company outlined positive results from two Phase 2b clinical studies, assessing HTX-011. The first study, known as Study 209 focused on local administration in total knee arthroplasty and the second, Study 211 focused on installation on pectoral pocket nerve block in breast augmentation. HRTX announced that in both studies, the treatment not only met its primary endpoints, but proved to be safe and well tolerated. In a statement, Barry D. Quart, Pharm.D., CEO at HRTX, had the following to offer:
With postoperative opioids serving as a gateway to addiction, there is a large unmet need for non-opioid pain alternatives… With the results reported today, we have seen positive results across 7 controlled clinical studies and 5 diverse surgical models, including hernia repair, abdominoplasty, bunionectomy, total knee arthroplasty and breast augmentation. We look forward to submitting an NDA to the FDA for HTX-011 in the second half of 2018.
In the second released offered by the company this morning, Heron Therapeutics announced that it has received Breakthrough Therapy Designation. In particular, the designation was provided to HTX-011 for postoperative pain management. Of course, Breakthrough Therapy Designation opens the door to more meetings and resources from the FDA as well as the potential for accelerated approval. In a statement, Dr. Quart, had the following to offer:
We are pleased that HTX-011 has received Breakthrough Therapy designation from the FDA… HTX-011 is the only long-acting local anesthetic to demonstrate significantly reduced postoperative pain and opioid use through 72 hours compared to bupivacaine solution, the standard-of-care local anesthetic for postoperative pain management, in Phase 3 studies. We look forward to working towards the submission of an NDA to the FDA for HTX-011 in the second half of 2018.
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 Heron Therapeutics, the news proved to be overwhelmingly positive. After all, not only did the company hit the nail on the head with regard to two important clinical trials, it has received Breakthrough Therapy Designation, shortening the road to approval for HTX-011. So, it’s 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 (9:29), HRTX is trading at $39.05 per share after a gain of $8.35 per share or 27.20% 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 HRTX. In particular, we’re interested in following the story surrounding the continued development of HTX-011 as the treatment seems to be yeilding overwhelmingly positive results. Nonetheless, we’ll continue to keep an eye on the news and bring it 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!