Heron Therapeutics, Inc. (NASDAQ:HRTX) reported change of 3.31% to $27.76 with the recent traded volume of 1203455 shares in most recent trading session compared to an average volume of 946.63K. The stock was changed with 8.73% over last five days period.
The one month performance of stock was noted at -9.84%. HRTX’s shares are moving at -24.36% for the quarter and managed a 80.85% return over the course of the past year and is now at 53.37% since this point in 2018.
Heron Therapeutics, Inc. (NASDAQ:HRTX), a commercial-stage biotechnology company focused on improving the lives of patients by developing best-in-class treatments to address some of the most important unmet patient needs, announced the submission of its New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for HTX-011. HTX-011 is an investigational, long-acting, extended-release formulation of the local anesthetic bupivacaine in a fixed-dose combination with the anti-inflammatory meloxicam for the management of postoperative pain.
HTX-011 was granted both Breakthrough Therapy and Fast Track designations from the FDA. The NDA filing is based on the results of 7 completed clinical studies in 5 bony and soft tissue surgical procedures that included over 1,000 patients who received HTX-011. These completed clinical studies included two Phase 3 studies in which HTX-011 demonstrated superior, sustained postoperative pain relief for 72 hours and decreased the need for opioids, with more patients who were opioid-free compared to placebo and bupivacaine solution, the current standard-of-care. The overall safety profile of HTX-011, administered locally into the surgical site without a needle, is similar to that of the well-established safety profile of bupivacaine solution, without evidence of meloxicam-related toxicities.
“In the U.S., opioid pain medications prescribed for pain control in over 40 million surgical patients have been directly linked to over 2 million new persistent opioid users every year, and over 400,000 new cases of Opioid Use Disorder annually. This makes postoperative opioid use an important contributor to the opioid epidemic. It must be highlighted that, with more than a billion opioid pills taken home after surgery every year for postoperative pain control, there is an enormous concern about diversion of these pills and a desperate need for effective non-opioid alternatives,” said Harold S. Minkowitz, M.D., Associate Professor and Associate Director of Clinical Research at the University of Texas MD Anderson Cancer Center, Department of Anesthesiology and Perioperative Medicine. “The clinical results with HTX-011 suggest it may be one of the most promising new non-opioid analgesics for a wide range of surgical procedures.”
Barry D. Quart, Pharm.D., Chief Executive Officer of Heron Therapeutics said “The submission of the NDA for HTX-011 in the U.S. is an important milestone, advancing our efforts to bring a non-opioid alternative to patients suffering from postoperative pain”. “As a company, this represents the third NDA filed by Heron. We have appreciated the frequent advice from the FDA during the development of HTX-011 and look forward to working closely with them during the NDA review process.”
The stock beta value is 1.46. HRTX stock changed at -10.66% distance from its 200-day moving average. On a similar note, the stock marked distance of -15.89% from its 50-day moving average and moved -4.45% away from its 20-day moving average. The average volatility for the week and month was at 7.11% and 6.53% respectively. Its quarter to quarter sales remained 103.50%. The company holds 76.44 million shares outstanding and 76.44 million shares are floated in market.