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.
24/7 Wall St.Sponsored: Attention Savvy Investors: Speak to 3 Financial Experts – FREE
Ever wanted an extra set of eyes on an investment you’re considering? Now you can speak with up to 3 financial experts in your area for FREE. By simply
clicking here you can begin to match with financial professionals who can help guide you through the financial decisions you’re making. And the best part? The first conversation with them is free.
Click here to match with up to 3 financial pros who would be excited to help you make financial decisions.
Thank you for reading! Have some feedback for us?
Contact the 24/7 Wall St. editorial team.
Editors' Picks
