Heron Therapeutics Inc. (NASDAQ: HRTX) shares saw a massive gain on Thursday after the company announced a few key developments. First, the firm provided positive results from its midstage trial, as well as a critical update from the U.S. Food and Drug Administration (FDA).
First, Heron announced positive topline results from two completed Phase 2b studies of HTX-011: Study 209 (local administration in total knee arthroplasty) and Study 211 (instillation or pectoral pocket nerve block in breast augmentation). HTX-011 achieved the primary endpoints in both studies, which was a reduction in pain intensity.
For some quick background: 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.
As for the FDA, the agency granted a Breakthrough Therapy designation for HTX-011 for postoperative pain management.
The Breakthrough Therapy designation was granted for HTX-011 based on the results of Phase 2 studies and two recently completed Phase 3 studies, which showed that HTX-011 produced significant reductions in both pain intensity and the need for opioids.
Barry D. Quart, Pharm.D., CEO of Heron, commented:
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.
Shares of Heron were last seen up about 30% at $39.95, with a consensus analyst price target of $40.62 and a 52-week range of $12.70 to $40.40.