Welcome to our dedicated page for Heron Therapeutics news (Ticker: HRTX), a resource for investors and traders seeking the latest updates and insights on Heron Therapeutics stock.
Heron Therapeutics, Inc. (Nasdaq: HRTX) is a commercial-stage biotechnology company whose news flow is closely tied to its acute care and oncology supportive care portfolio. The company regularly issues updates on its marketed products ZYNRELEF, APONVIE, CINVANTI, and SUSTOL, as well as financial and corporate developments that affect HRTX stock.
On this page, readers can follow HRTX news related to quarterly and annual financial results, net revenue trends by product, and guidance updates disclosed in earnings press releases. Heron’s announcements often break out performance for its Acute Care franchise, which includes ZYNRELEF for postoperative pain and APONVIE for prevention of postoperative nausea and vomiting in adults, and its Oncology franchise, which includes CINVANTI and SUSTOL for prevention of chemotherapy-induced nausea and vomiting.
Company news also covers regulatory and clinical milestones for Heron’s products. Examples from past releases include FDA approvals and label expansions for ZYNRELEF in various soft tissue and orthopedic surgical procedures, and recognition of APONVIE in consensus guidelines for the management of postoperative nausea and vomiting. These items help investors and clinicians track how product indications and clinical positioning evolve over time.
In addition, Heron reports capital markets and governance events through press releases and corresponding SEC filings. Recent topics have included comprehensive capital restructuring, new credit facilities and convertible note transactions, adoption of a Tax Benefit Preservation Plan to protect net operating loss carryforwards, and Board-level changes such as cooperation agreements with investors and director appointments. For users monitoring HRTX, this news feed offers a consolidated view of operational, financial, regulatory, and governance developments that the company has publicly disclosed.
Heron Therapeutics (HRTX) announced that the European Commission granted marketing authorization for ZYNRELEF (formerly HTX-011) to treat postoperative pain from small- to medium-sized surgical wounds in adults. This follows a positive opinion from the EMA in July 2020. ZYNRELEF is a non-opioid, dual-acting analgesic that combines bupivacaine and meloxicam, effectively managing pain with reduced opioid use for up to 72 hours. The authorization allows ZYNRELEF's availability in the EU in 2021, significantly benefiting surgical patients. Heron also plans to respond to inquiries regarding HTX-011 from Health Canada.
Heron Therapeutics (Nasdaq: HRTX) announced the publication of positive results from the EPOCH 2 follow-on study for investigational drug HTX-011, demonstrating its efficacy in opioid-free recovery for patients undergoing inguinal hernia repair. Over 90% of patients remained opioid-free for 72 hours post-surgery, with mean pain intensity remaining mild. HTX-011, a combination of bupivacaine and meloxicam, outperformed standard anesthetics in reducing pain. The study supports HTX-011's potential to personalize pain management, significantly limiting opioid prescriptions. Safety data indicated HTX-011 was well tolerated.
Heron Therapeutics, Inc. (Nasdaq: HRTX) will participate in a fireside chat at the Cantor Virtual Global Healthcare Conference on September 17, 2020, at 1:20 p.m. EDT. Barry Quart, the company's President and CEO, will represent Heron, focusing on innovative treatments for pain and cancer. A live webcast can be accessed on their website, with a replay available for 60 days. Heron is dedicated to addressing significant unmet medical needs through advanced biotechnology.
Heron Therapeutics (Nasdaq: HRTX) announced a successful Type A meeting with the FDA regarding the resubmission of the New Drug Application (NDA) for HTX-011, aimed at managing postoperative pain. The company plans to resubmit the NDA in Q4 2020. HTX-011 combines bupivacaine and meloxicam and is the first extended-release local anesthetic to show significant pain reduction and lower opioid use in Phase 3 studies. The FDA expressed positive feedback on Heron's plans to address previous issues raised in a Complete Response Letter.
Heron Therapeutics (HRTX) reported Q2 financial results with net product sales of $22.7 million, down from $36.7 million in Q2 2019. The net loss for the quarter was $55.2 million, or $0.61 per share. A positive CHMP opinion was received for ZYNRELEF in the EU, while the FDA issued a Complete Response Letter for HTX-011, requiring additional information. Net cash stood at $300.8 million, down from $391.0 million at year-end 2019, with guidance for CINV franchise sales maintained at $70 million to $80 million despite challenges from COVID-19.
Heron Therapeutics (Nasdaq: HRTX) announced on June 29, 2020, that it received a Complete Response Letter (CRL) from the FDA for its New Drug Application (NDA) for HTX-011, aimed at managing postoperative pain. The CRL cited the need for additional non-clinical information but did not find any clinical safety or efficacy issues. Heron plans to address these issues and resubmit the application. HTX-011 is a non-opioid analgesic that has shown promise in reducing pain and opioid use in clinical trials.