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 (Nasdaq: HRTX) announced the publication of the EPOCH 1 follow-on study results in the Journal of the American Podiatric Medical Association. The study demonstrated that 77% of bunionectomy patients treated with HTX-011, a dual-acting local anesthetic, remained opioid-free for 28 days post-surgery. Patients reported mild pain intensity and significant pain reduction compared to standard treatments. HTX-011 was well tolerated, with a safety profile similar to placebo. The FDA has granted Breakthrough Therapy designation for HTX-011, with an NDA review goal set for May 12, 2021.
Heron Therapeutics (Nasdaq: HRTX) announced progress in its pain management and chemotherapy-induced nausea and vomiting (CINV) franchises, alongside a new program targeting postoperative nausea and vomiting (PONV). The FDA is reviewing the NDA for HTX-011, with a decision expected by May 12, 2021. Preliminary Q4 2020 net sales for CINV reached $20.3 million, while full-year guidance for 2021 is set between $130 million and $145 million. Notably, HTX-019 showed bioequivalence to oral aprepitant, with an NDA anticipated later in 2021.
Heron Therapeutics (HRTX) has resubmitted its New Drug Application (NDA) for HTX-011 to the FDA, addressing issues outlined in a Complete Response Letter from June 2020. The resubmission follows a Type A End-of-Review meeting in September, where the FDA agreed with Heron's proposed changes. HTX-011 is a non-opioid analgesic intended for postoperative pain management. The FDA will classify this as a Class 2 resubmission, allowing up to six months for review. HTX-011 has received Breakthrough Therapy and Priority Review designations.
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.