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. reports commercial and financial developments for a commercial-stage biotechnology business focused on acute care and oncology products. News commonly covers revenue performance and guidance for the Acute Care franchise, including ZYNRELEF and APONVIE, as well as oncology product updates involving CINVANTI and the broader product portfolio.
Company updates also address APONVIE’s role as an FDA-approved IV NK-1 receptor antagonist for prevention of postoperative nausea and vomiting in adults, ZYNRELEF product-handling initiatives for hospital and ambulatory surgical center use, distribution and sales-force activity, intellectual-property matters, and board or governance changes.
Heron Therapeutics, Inc. (Nasdaq: HRTX) announced that CEO Barry Quart will present at three upcoming virtual investor conferences. The events include the Stifel 2020 Virtual Healthcare Conference on November 17 at 3:20 pm ET, the Jefferies Virtual London Healthcare Conference on November 19 at 1:30 pm GMT, and the 3rd Annual Evercore ISI HealthCONx Conference on December 1 at 4:20 pm ET. Each presentation will be webcast live and available for replay for 60 days on their website.
Heron Therapeutics (HRTX) reported Q3 and nine-month results for 2020, showing net product sales of $20 million and $68 million, down from $42.6 million and $110.9 million in 2019. The company announced a marketing authorization for ZYNRELEF in the EU and successful FDA meeting for HTX-011 resubmission. Heron raised its 2020 CINV sales guidance from $70-$80 million to $85 million, despite challenges from COVID-19. Net loss increased to $58.2 million for Q3 and $165 million for the nine months. As of September 30, 2020, cash reserves totaled $258.1 million, expected to sustain operations into 2022.
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.