Heron : FDA Grants Priority Review Designation For NDA For HTX-011; Stock Up

(RTTNews) - Heron Therapeutics Inc. (HRTX) said that the U.S. Food and Drug Administration has accepted the new drug application or NDA for Heron's investigational agent, HTX-011, and has granted it a Priority Review designation.

In Monday pre-market trade, HRTX is trading at $25.25, up $1.50 or 6.32 percent.

HTX-011 is a 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 is the first and only dual-action fixed-combination product specifically designed to address both postoperative pain and inflammation in a single administration at the surgical site.

The NDA for HTX-011, which was submitted on October 30, 2018, comprises data from five Phase 2 clinical trials and two Phase 3 clinical trials that included over 1,000 patients undergoing five different surgical procedures.

The FDA also indicated that it is not currently planning to hold an advisory committee meeting to discuss this application. The FDA set a Prescription Drug User Fee Act goal date of April 30, 2019.