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January 27, 2014
08:04 EDTHRTXHeron sees one-quarter delay to timeline for Sustol NDA resubmission
Heron Therapeutics announced an approximate one-quarter delay to the company’s timeline for the resubmission of the new drug application for Sustol to the U.S. Food and Drug Administration, the company’s product candidate for chemotherapy-induced nausea and vomiting. The company received notice last week from the supplier of the syringes used for Sustol injections that the production order of syringes manufactured for Heron, and scheduled to be used in the validation of the commercial manufacturing process for Sustol required for resubmission of the NDA, will be delayed due to equipment failure of an in-process quality control check. The equipment failure is not specific to Sustol or Heron, and remedial efforts are underway. “While the timing of our resubmission will be impacted by this delay, we expect it to have minimal impact on our projected timing of the launch of Sustol,” said Barry D. Quart, PharmD, CEO. “Subject to the FDA’s review and approval of the Sustol NDA, we project being in a position to launch Sustol in early 2015, which presents more optimal timing than potentially launching into the late 2014 holiday season.”
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May 28, 2015
16:40 EDTHRTXHeron Therapeutics up 40% following positive results from Sustol study
16:11 EDTHRTXHeron Therapeutics announces positive results from Phase 3 MAGIC study of Sustol
Heron Therapeutics announced positive, top-line results from its recently completed Phase 3 MAGIC study. MAGIC evaluated the efficacy and safety of the Company’s 5-HT3 receptor antagonist product candidate Sustol as part of a three-drug regimen with the intravenous neurokinin-1 receptor antagonist fosaprepitant and the IV corticosteroid dexamethasone for the prevention of delayed-onset chemotherapy-induced nausea and vomiting following administration of highly emetogenic chemotherapy agents. The MAGIC study is the only Phase 3 CINV prophylaxis study in a HEC population performed to-date to use as a comparator the currently recommended, standard-of-care, three-drug regimen: a 5-HT3 receptor antagonist, fosaprepitant and dexamethasone. The study was conducted entirely in the U.S. and enrolled over 900 patients undergoing HEC treatment for various tumor types. The primary endpoint in this study was the proportion of patients who achieved a Complete Response, defined as no emesis and no rescue medications during the delayed-onset phase of CINV, occurring 24-120 hours following administration of HEC agents. The study’s major efficacy findings include: The study’s primary endpoint was achieved. The percentage of patients who achieved a Complete Response was significantly higher in the Sustol group than the comparator group (64.7% vs. 56.6%, p=0.014).
May 15, 2015
07:28 EDTHRTXHeron Therapeutics shares remain undervalued, says Brean Capital
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May 14, 2015
08:01 EDTHRTXHeron Therapeutics says FDA accepts propsal to use 505(b)(2) pathway for HTX-019
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