Business
Heron Therapeutics Announces Financial Results for the Three and Nine Months Ended September 30, 2019 and Highlights Recent Corporate Updates
SAN DIEGO, Nov. 12, 2019 /PRNewswire/ -- Heron Therapeutics, Inc. (Nasdaq: HRTX), a commercial-stage biotechnology company focused on improving the lives of
About this update from Heron Therapeutics, Inc.
[{"type":"text","content":"SAN DIEGO, Nov. 12, 2019 /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 financial results for the three and nine months ended September 30, 2019 and highlighted recent corporate updates.\nRecent Corporate Updates\nPain Management Franchise\nFDA Acceptance of New Drug Application Resubmission for HTX-011: In October 2019, the U.S. Food and Drug Administration (FDA) accepted Heron's New Drug Application (NDA) resubmission for HTX-011, an investigational agent for the management of postoperative pain. The FDA set a Prescription Drug User Fee Act (PDUFA) goal date of March 26, 2020. Positive Topline Results from Phase 3b Clinical Study of HTX-011 in Total Knee Arthroplasty: In October 2019, Heron reported positive topline results of a multi-center postoperative pain management study in which 51 patients undergoing total knee arthroplasty (TKA) surgery received HTX-011 together with a scheduled postoperative regimen of generic oral analgesics (acetaminophen and celecoxib). In this study, 75% of patients were discharged from the hospital without a prescription for opioids.CINV Franchise \nCINV 2019 Net Product Sales: For the three months ended September 30, 2019, chemotherapy-induced nausea and vomiting (CINV) franchise net product sales were $42.6 million, up 115% from the same period in 2018, and up 16% from the three months ended June 30, 2019. For the nine months ended September 30, 2019, CINV franchise net product sales were $110.9 million, up 128% from the same period in 2018. Heron is raising its full-year 2019 CINV franchise net product sales guidance from $115–120 million to $135 million. CINVANTI Net Product Sales: Net product sales of CINVANTI (aprepitant) injectable emulsion for the three and nine months ended September 30, 2019 were $36.4 million and $97.6 million, respectively, compared to $16.4 million and $32.8 million, respectively, for the same periods in 2018. SUSTOL® Net Product Sales: Net product sales of SUSTOL (granisetron) extended-release injection for the three and nine months ended September 30, 2019 were $6.2 million and $13.3 million, respectively, compared to $3.4 million and $15.8 million for the sam...