Heron Therapeutics Inc (NASDAQ:HRTX) announced that it has initiated a Phase 2 clinical trial of HTX-011, the Company’s lead product candidate for the prevention of post-operative pain, following clearance from the U.S. Food and Drug Administration (FDA) of its Investigational New Drug (IND) application for HTX-011. HTX-011, which utilizes Heron’s proprietary Biochronomer® drug delivery technology, is a long-acting formulation of the local anesthetic bupivacaine in a fixed-dose combination with the anti-inflammatory meloxicam.
The placebo-controlled, dose-finding, Phase 2 clinical trial in approximately 60 patients undergoing bunionectomy will evaluate the efficacy and safety of HTX-011, containing 200 mg or 400 mg of bupivacaine combined with meloxicam, compared to placebo. In a previously completed, placebo-controlled, Phase 1 clinical trial of HTX-011 in healthy volunteers, the desired pharmacokinetic profile for both bupivacaine and meloxicam was achieved, with therapeutically relevant drug levels of bupivacaine sustained for 2-3 days. Heron anticipates reporting top-line results from this Phase 2 clinical trial in the second half of 2015.
“We are excited to be moving HTX-011, an innovative product candidate targeting the large and growing post-operative pain management market, into a Phase 2 study in an important surgical indication,” commented Barry D. Quart, Pharm.D., Chief Executive Officer of Heron. “We believe that HTX-011 has the potential to meet our core goal of developing best-in-class medicines with the potential to significantly improve the lives of patients.” (Original Source)
Shares of Heron Therapeutics Inc closed yesterday at $31.85 . HRTX has a 1-year high of $32.22 and a 1-year low of $6.51. The stock’s 50-day moving average is $17.09 and its 200-day moving average is $12.73.
On the ratings front, Brean Murray Carret analyst Jonathan Aschoff reiterated a Buy rating on HRTX, with a price target of $40, in a report issued on May 29. The current price target represents a potential upside of 25.6% from where the stock is currently trading.
According to TipRanks.com, Aschoff has a total average return of 9.9%, a 53.2% success rate, and is ranked #305 out of 3629 analysts.
Heron Therapeutics Incis a biotechnology company, developing products to address unmet medical needs. ItsproprietaryBiochronomer polymer-based drug delivery platform is designed to improve the therapeutic profile of injectable pharmaceuticals.