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Last $26.65 USD
Change Today +0.58 / 2.22%
Volume 1.4M
HRTX On Other Exchanges
As of 8:10 PM 10/8/15 All times are local (Market data is delayed by at least 15 minutes).

heron therapeutics inc (HRTX) Snapshot

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09/23/15 - $42.25
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heron therapeutics inc (HRTX) Details

Heron Therapeutics, Inc., a biotechnology company, develops products to address unmet medical needs using its proprietary Biochronomer drug delivery platform in the United States. Its drug delivery platform is designed to enhance the therapeutic profile of injectable pharmaceuticals. The company’s lead product candidate, SUSTOL (granisetron Injection, extended release), is being developed for the prevention of acute- and delayed chemotherapy-induced nausea and vomiting. The company resubmitted a new drug application for SUSTOL to the U.S. Food and Drug Administration. In addition, it is developing HTX-011, which is in Phase II clinical development for the management of post-operative pain; HTX-019, an injectable neurokinin-1 receptor antagonist for the prevention of chemotherapy induced nausea and vomiting; and HTX-003, a formulation of buprenorphine for the management of chronic pain and opioid addiction. The company was formerly known as A.P. Pharma, Inc. and changed its name to Heron Therapeutics, Inc. in January 2014. Heron Therapeutics, Inc. was founded in 1983 and is headquartered in Redwood City, California.

59 Employees
Last Reported Date: 03/13/15
Founded in 1983

heron therapeutics inc (HRTX) Top Compensated Officers

Chief Executive Officer and Director
Total Annual Compensation: $540.8K
President and Director
Total Annual Compensation: $540.8K
Chief Financial Officer and Vice President of...
Total Annual Compensation: $285.0K
Senior Vice President of Technical Operations
Total Annual Compensation: $395.0K
Compensation as of Fiscal Year 2014.

heron therapeutics inc (HRTX) Key Developments

Heron Therapeutics, Inc. - Special Call

To discuss results from phase 2 study of HTX-011 in the management of post-operative pain

Heron Therapeutics, Inc. Reports Results from Phase 2 Study of HTX-011 in the Management of Post-Operative Pain

Heron Therapeutics, Inc. announced positive results from its Phase 2 clinical study of HTX-011 in the management of post-operative pain in patients undergoing bunionectomy. 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 primary and all key secondary endpoints in the study were met with a high degree of statistical significance. This randomized, placebo-controlled, double-blind, Phase 2 clinical study in 64 patients undergoing bunionectomy evaluated the efficacy and safety of HTX-011, containing 200 mg or 400 mg of bupivacaine combined with meloxicam, compared to placebo. The primary endpoint was the difference as compared to placebo in pain intensity as measured by the Summed Pain Intensity (SPI) score in the first 24 hours post-surgery (SPI 0-24). Key secondary endpoints included: the difference in SPI in the first 48 hours post-surgery (SPI 0-48); the difference in SPI in the first 72 hours post-surgery (SPI 0-72); time to the first use of opiate rescue medication; and the percent of patients who received no opiate rescue medication in the first 72 hours post-surgery. The study’s major efficacy findings for the more effective, 400 mg dose of HTX-011 as compared to placebo include: pain intensity in the first 24 hours post-surgery was reduced by 69% (SPI of 38.5 versus 124.2, p<0.0001); pain intensity in the first 48 hours post-surgery was reduced by 52% (SPI of 106.9 versus 224.8, p<0.0001); pain intensity in the first 72 hours post-surgery was reduced by 40% (SPI of 170.2 versus 285.9, p=0.0064); time to the first use of opiate rescue medication was increased by 488% (48.2 hours versus 8.2 hours, p<0.0001); and 32% of patients received no opiate rescue medication during the entire 72-hour period post-surgery, compared to 5% for placebo (p<0.0001). HTX-011 was generally well tolerated in the study. The most frequent adverse events reported were headache, nausea, vomiting, erythema, cellulitis, dizziness, and hypoxia, none of which were considered drug-related.

Heron Therapeutics, Inc. to Present Data from Completed Phase 3 Magic Study of SUSTOL at ASCO Breast Cancer Symposium

Heron Therapeutics, Inc. announced that data from company's recently completed MAGIC Study of SUSTOL (granisetron) Injection, extended release, for the prevention of chemotherapy-induced nausea and vomiting (CINV) in patients receiving highly emetogenic chemotherapy (HEC), will be presented at the American Society of Clinical Oncology (ASCO) 2015 Breast Cancer Symposium on Saturday, September 26, 2015 in San Francisco, CA. Heron will present a poster and give an oral presentation for the abstract titled Phase III Study of APF530 versus Ondansetron with a Neurokinin 1 Antagonist + Corticosteroid in Preventing Highly Emetogenic Chemotherapy-Induced Nausea and Vomiting: MAGIC Trial. SUSTOL (granisetron) Injection, extended release, which utilizes Heron’s proprietary Biochronomer drug delivery technology, is Heron’s novel, long-acting formulation of granisetron for the prevention of chemotherapy-induced nausea and vomiting (CINV). Granisetron, an FDA-approved 5-hydroxytryptamine type 3 (5-HT3) receptor antagonist was selected due to its broad use by physicians based on a well-established record of safety and efficacy. SUSTOL has been shown to maintain therapeutic drug levels of granisetron for five days with a single subcutaneous injection. SUSTOL is being developed for the prevention of both acute (day 1 following the administration of chemotherapy agents) and delayed (days 2-5 following the administration of chemotherapy agents) CINV associated with moderately emetogenic chemotherapy (MEC) or highly emetogenic chemotherapy (HEC). While other 5-HT3 antagonists are approved for the prevention of CINV, SUSTOL is the first agent in the class to demonstrate efficacy in reducing the incidence of delayed CINV in patients receiving HEC, a major unmet medical need, in a randomized Phase 3 study. Affecting 70-80% of patients undergoing chemotherapy, CINV is one of the most debilitating side effects of such treatments, often attributed as a cause of premature discontinuation of cancer treatment. 5-HT3 receptor antagonists have been shown to be among the most effective and preferred treatments for CINV. However, an unmet medical need exists for patients suffering from CINV during the delayed phase, which occurs on days 2-5 following the administration of chemotherapy agents. Only one 5-HT3 receptor antagonist is approved for the prevention of delayed CINV associated with MEC, and no 5-HT3 receptor antagonists are approved for prevention of delayed CINV associated with HEC. SUSTOL was the subject of a recently completed, multi-center, placebo-controlled, Phase 3 clinical study in patients receiving HEC regimens known as MAGIC. The MAGIC study evaluated the efficacy and safety of SUSTOL as part of a three-drug regimen with the intravenous (IV) neurokinin-1 (NK1) receptor antagonist fosaprepitant and the corticosteroid dexamethasone. The MAGIC study, which was conducted entirely in the U.S. using the 2011 ASCO guidelines for classification of emetogenic potential, is the only Phase 3 CINV prophylaxis study in a HEC population performed to date to use the currently recommended, standard-of-care, three-drug regimen as a comparator: a 5-HT3 receptor antagonist, fosaprepitant, and dexamethasone. Adverse events reported in the study were generally mild to moderate in severity and of short duration, with the most common being injection site reactions (ISRs). In July 2015, Heron resubmitted its New Drug Application (NDA) for SUSTOL to the U.S. Food and Drug Administration (FDA), and the FDA has assigned a Prescription Drug User Fee Act (PDUFA) goal date of January 17, 2016. SUSTOL is not approved by the FDA or any other regulatory authority.


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