Heron Therapeutics Stock Price, News & Analysis

Heron Therapeutics, Inc. (Nasdaq: HRTX) is a commercial-stage biotechnology company in the pharmaceutical preparation manufacturing industry. According to the company’s public disclosures, Heron focuses on improving the lives of patients by developing and commercializing therapeutic innovations that improve medical care. Its portfolio is centered on products that aim to advance the standard of care for acute care and oncology patients.

Business focus and therapeutic areas

Heron describes itself as using advanced science, patented technologies and its own approach to drug discovery and development to create marketed therapies. The company’s products address two main therapeutic areas:

• Acute care – focused on postoperative pain and postoperative nausea and vomiting (PONV).
• Oncology supportive care – focused on chemotherapy-induced nausea and vomiting (CINV).

Heron’s product portfolio, as described in its press releases, consists of ZYNRELEF, APONVIE, CINVANTI, and SUSTOL. These products are all approved prescription medicines with detailed indications in the United States prescribing information.

ZYNRELEF for postoperative pain

ZYNRELEF is described by Heron as the first and only extended-release dual-acting local anesthetic that delivers a fixed-dose combination of the local anesthetic bupivacaine and a low dose of the nonsteroidal anti-inflammatory drug meloxicam. In Phase 3 studies cited by the company, ZYNRELEF demonstrated significantly reduced pain and a significantly increased proportion of patients requiring no opioids through the first 72 hours following surgery compared to bupivacaine solution, which the company refers to as the current standard-of-care local anesthetic for postoperative pain control.

Heron reports that ZYNRELEF was initially approved by the U.S. Food and Drug Administration (FDA) in May 2021 for use in adults for soft tissue or periarticular instillation to produce postsurgical analgesia for up to 72 hours after bunionectomy, open inguinal herniorrhaphy and total knee arthroplasty. In December 2021, the FDA expanded ZYNRELEF’s indication to include foot and ankle, small-to-medium open abdominal, and lower extremity total joint arthroplasty procedures. On January 23, 2024, the FDA approved ZYNRELEF for soft tissue and orthopedic surgical procedures including foot and ankle, and other procedures in which direct exposure to articular cartilage is avoided. The company notes that safety and efficacy have not been established in highly vascular surgeries such as intrathoracic, large multilevel spinal, and head and neck procedures.

APONVIE for prevention of postoperative nausea and vomiting

APONVIE is described as a substance P/neurokinin 1 (NK1) receptor antagonist indicated for the prevention of postoperative nausea and vomiting (PONV) in adults. Heron states that APONVIE is delivered via a 30‑second intravenous push, and that a 32 mg dose was demonstrated to be bioequivalent to oral aprepitant 40 mg with rapid achievement of therapeutic drug levels. APONVIE uses the same formulation as Heron’s approved drug product CINVANTI and is supplied in a single‑dose vial that delivers the full 32 mg dose for PONV prevention.

The company reports that APONVIE was approved by the FDA in September 2022 and became commercially available in the United States on March 6, 2023. In later communications, Heron highlights that APONVIE is an aprepitant injectable emulsion and notes its inclusion in consensus guidelines for the management of PONV as an NK‑1 receptor antagonist option for adults.

CINVANTI for chemotherapy-induced nausea and vomiting

CINVANTI is indicated, in combination with other antiemetic agents, in adults for the prevention of acute and delayed nausea and vomiting associated with initial and repeat courses of highly emetogenic cancer chemotherapy (including high‑dose cisplatin) as a single‑dose regimen, delayed nausea and vomiting associated with initial and repeat courses of moderately emetogenic chemotherapy as a single‑dose regimen, and nausea and vomiting associated with initial and repeat courses of moderately emetogenic chemotherapy as a 3‑day regimen.

Heron describes CINVANTI as an intravenous formulation of aprepitant, an NK1 receptor antagonist. It is characterized as the first IV formulation to directly deliver aprepitant, the active ingredient in EMEND capsules. The FDA‑approved dosing administration in the U.S. prescribing information for CINVANTI includes 100 mg or 130 mg administered as a 30‑minute IV infusion or a 2‑minute IV injection.

SUSTOL for CINV prevention

SUSTOL is indicated, in combination with other antiemetics in adults, for the prevention of acute and delayed nausea and vomiting associated with initial and repeat courses of moderately emetogenic chemotherapy or anthracycline and cyclophosphamide combination chemotherapy regimens. Heron states that SUSTOL is an extended‑release, injectable 5‑hydroxytryptamine type 3 receptor antagonist that utilizes the company’s Biochronomer drug delivery technology to maintain therapeutic levels of granisetron for at least five days.

The company’s disclosures note that the SUSTOL global Phase 3 development program consisted of two large, guideline‑based clinical studies evaluating efficacy and safety in more than 2,000 patients with cancer, with efficacy assessed in both the acute phase (0–24 hours after chemotherapy) and delayed phase (24–120 hours after chemotherapy).

Commercial-stage operations and portfolio structure

Across multiple press releases and SEC filings, Heron consistently describes itself as a commercial-stage biotechnology company. It reports net revenue from its marketed products and refers to two primary commercial groupings: an Acute Care franchise, which includes ZYNRELEF and APONVIE, and an Oncology franchise, which includes CINVANTI and SUSTOL. The company provides regular updates on net revenue performance by product and franchise in its earnings announcements.

Heron’s public communications emphasize that its marketed products are intended to address postoperative pain, postoperative nausea and vomiting, and chemotherapy-induced nausea and vomiting, areas the company characterizes as critical to patient experience and medical outcomes in surgical and oncology settings.

Corporate and capital structure highlights

Heron is incorporated in Delaware and files reports with the U.S. Securities and Exchange Commission (SEC). It trades on Nasdaq under the ticker symbol HRTX. The company has disclosed several notable corporate and capital structure actions in its SEC filings:

• Entry into amended working capital and credit arrangements with Hercules Capital, Inc., extending maturities and providing term loan capacity.
• Exchange and refinancing of senior convertible notes, including repayment of existing notes, issuance of new convertible senior unsecured promissory notes due 2031, and related private placements of common stock and Series A Convertible Preferred Stock.
• Adoption of a Tax Benefit Preservation Plan designed to protect the potential value of the company’s net operating loss carryforwards under Section 382 of the Internal Revenue Code.
• Use of preferred stock purchase rights and a designated Series B Preferred Stock as part of that tax benefit preservation structure.
• Corporate governance developments, including a cooperation agreement with Rubric Capital Management LP and the appointment of an additional director to the Board.

These actions are described by the company as intended to enhance financial flexibility, manage debt maturities, and protect tax attributes that may offset future taxable income.

Facilities and manufacturing relationships

In its SEC filings, Heron has disclosed entering into an office lease for new corporate headquarters space in Cary, North Carolina. The company has also described a framework agreement and amended manufacturing and supply arrangements with Patheon Austria GmbH & Co KG, under which Patheon manufactures and supplies specified quantities of products, performs stability studies, and provides warehousing services, subject to the terms of a manufacturing and supply agreement.

Regulatory reporting and governance

Heron files periodic and current reports with the SEC, including Forms 10‑K, 10‑Q, 8‑K, and proxy statements on Schedule 14A. These filings cover topics such as financial results, stockholder meetings, voting matters, director appointments, capital transactions, and material agreements. The company’s proxy materials describe stockholder voting procedures, virtual meeting logistics, and proposals related to the issuance of common stock upon conversion of certain convertible securities.

Summary

Overall, Heron Therapeutics, Inc. presents itself as a Nasdaq‑listed, commercial-stage biotechnology company with a focused portfolio of FDA‑approved products targeting postoperative pain, postoperative nausea and vomiting, and chemotherapy-induced nausea and vomiting. Through its acute care and oncology franchises, proprietary delivery technologies such as Biochronomer, and ongoing regulatory and capital markets activities, the company’s disclosures emphasize its goal of improving medical care and advancing standards of care in surgical and oncology settings.