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Heron Therapeutics Announces Third Quarter 2015 Financial Results and Recent Corporate Progress

REDWOOD CITY, Calif.--(BUSINESS WIRE)--Heron Therapeutics, Inc. (NASDAQ:HRTX), a biotechnology company focused on improving the lives of patients by developing best-in-class medicines that address major unmet medical needs, today reported third quarter 2015 financial results and highlighted recent corporate progress.

“This has been an exciting quarter for Heron with the FDA’s acceptance of the SUSTOL NDA and the release of positive, top-line results from our Phase 2 study of HTX-011 in patients undergoing bunionectomy”

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Recent Corporate Progress:

  • In October 2015, Heron appointed Neil J. Clendeninn, M.D., Ph.D. as Senior Vice President and Chief Medical Officer. Dr. Clendeninn brings more than 25 years of drug development and clinical practice experience to his role at Heron. Prior to his appointment, Dr. Clendeninn advised Heron during the recently completed MAGIC study for SUSTOL® (granisetron) Injection, extended release and with the resubmission of Heron’s New Drug Application (NDA) for SUSTOL to the U.S. Food and Drug Administration (FDA). Dr. Clendeninn, in addition to his experience as a practicing physician, has held academic positions, and served as a board member and scientific advisor for numerous institutions and companies within the oncology field.
  • In September 2015, Heron reported positive, top-line results from its recently completed Phase 2 clinical study of HTX-011 in the management of post-operative pain in patients undergoing bunionectomy. In the study, HTX-011 showed a significant reduction in pain intensity, reduction in the need for opioid rescue medications, and increase in time to first use of rescue medications.
  • In September 2015, the FDA accepted for review Heron’s NDA resubmission for SUSTOL 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. The FDA assigned a Prescription Drug User Fee Act (PDUFA) goal date of January 17, 2016.

Business Updates:

  • Based on the positive Phase 2 results of HTX-011 in patients undergoing bunionectomy, the Company plans to expand target enrollment for its ongoing Phase 2 clinical trial of HTX-011 in patients undergoing inguinal hernia repair. The increased target enrollment to approximately 100 patients now is expected to provide 90% power to detect a statistical improvement (p < 0.05) in the study. The Company expects to report results from this study in the first half of 2016.
  • Heron plans to study HTX-011 as part of a broad-based development program designed to target patients undergoing a wide range of surgeries who experience significant post-operative pain, potentially including abdominoplasty, orthopedic procedures, nerve block and further studies in inguinal hernia repair and bunionectomy.

“This has been an exciting quarter for Heron with the FDA’s acceptance of the SUSTOL NDA and the release of positive, top-line results from our Phase 2 study of HTX-011 in patients undergoing bunionectomy,” commented Barry D. Quart, Pharm.D., Chief Executive Officer of Heron Therapeutics. “We look forward to a productive fourth quarter with the continuation of our activities in preparation for the potential commercial launch of SUSTOL, if...


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