FDA Grants Priority Review Designation for Heron Therapeutics' NDA for HTX-011, a Non-Opioid for Postoperative Pain Management
Heron Therapeutics, Inc. (HRTX)
Last heron therapeutics, inc. earnings: 3/2 07:30 am
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Source: PR Newswire
SAN DIEGO, Dec. 31, 2018 /PRNewswire/ -- 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, today announced that the U.S. Food and Drug Administration (FDA) has accepted the new drug application (NDA) for Heron's investigational agent, HTX-011, and has granted it a Priority Review designation. 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
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HRTX
Earnings
- 3/12/24 - Beat
HRTX
Sec Filings
- 4/19/24 - Form 4
- 4/19/24 - Form PRE
- 4/19/24 - Form 4
- HRTX's page on the SEC website