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Last $32.34 USD
Change Today +0.65 / 2.05%
Volume 764.9K
HRTX On Other Exchanges
As of 8:10 PM 07/31/15 All times are local (Market data is delayed by at least 15 minutes).

heron therapeutics inc (HRTX) Snapshot

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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 polymer-based 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 includes SUSTOL (granisetron injection, extended release), which is in Phase III clinical trial for the prevention of acute- and delayed-onset chemotherapy-induced nausea and vomiting. It is also developing HTX-011 that is in Phase I clinical trial 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. Initiates Second Phase 2 Clinical Trial of HTX-011 for the Treatment of Post-Operative Pain

Heron Therapeutics, Inc. announced that it has initiated a second Phase 2 clinical trial of HTX-011. 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 for the prevention of post-operative pain. The placebo-controlled, dose-finding, Phase 2 clinical trial in approximately 60 patients undergoing inguinal hernia repair will evaluate the efficacy and safety of HTX-011, containing 200 mg or 400 mg of bupivacaine combined with meloxicam, compared to placebo. HTX-011 is also currently being evaluated in a placebo-controlled, dose-finding, Phase 2 clinical trial in patients undergoing bunionectomy. In a previously completed, placebo-controlled, Phase 1 clinical trial, HTX-011 achieved the desired pharmacokinetic profile for both bupivacaine and meloxicam, with therapeutically relevant plasma bupivacaine levels sustained for 2-3 days.

Heron Therapeutics Resubmits SUSTOL® New Drug Application to FDA

Heron Therapeutics, Inc. announced that it has resubmitted its New Drug Application (NDA) for SUSTOL® (granisetron) Injection, extended release, for the prevention of acute and delayed chemotherapy-induced nausea and vomiting (CINV) associated with moderately emetogenic chemotherapy (MEC) or highly emetogenic chemotherapy (HEC) regimens, to the U.S. Food and Drug Administration (FDA). Heron expects confirmation of acceptance from the FDA and a Prescription Drug User Fee Act (PDUFA) goal date within the next few weeks. The Company anticipates a six-month review by the FDA. The NDA filing includes data from the MAGIC study, Heron’s recently completed, multi-center, placebo-controlled, Phase 3 study in patients receiving HEC agents. 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 IV/oral corticosteroid dexamethasone for the prevention of delayed nausea and vomiting in patients receiving HEC. 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 study to-date to use the currently recommended, standard-of-care, three-drug regimen for CINV prophylaxis in a HEC population as the comparator: a 5-HT3 receptor antagonist, fosaprepitant and dexamethasone. The MAGIC study’s primary endpoint was achieved. Specifically, the percentage of patients who achieved a Complete Response was significantly higher in the SUSTOL arm compared with the comparator arm (p=0.014). Significant benefit was also observed in the reduction in episodes of nausea, which has the great impact on patient quality of life. Data from a previous Phase 3 study of more than 1,300 patients, which was previously submitted to the FDA, demonstrated SUSTOL’s efficacy in the prevention of acute and delayed CINV associated with MEC regimens and acute CINV associated with HEC regimens.

Heron Therapeutics, Inc. Approves the Amendment to the Bylaws

On June 29, 2015, the board of directors of Heron Therapeutics, Inc. approved and adopted the amended and restated bylaws of the company. The bylaws include a number of updated provisions, including: specifying that certain provisions of the bylaws may not be amended or repealed without the affirmative vote of the holders of at least 66-2/3% of the voting rights of the company, voting together as a single class; providing for uncertificated shares of the Company's capital stock; a forum selection clause specifying Delaware as the sole and exclusive forum for derivative or breach of duty suits or proceedings, claims relative to the general corporation law of Delaware, the certificate of incorporation or bylaws of the company, or suits pertaining to the internal affairs of the company; and the addition of an outside date for stockholder proposals and director nominations and informational requirements in connection with such proposals and director nominations.


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