HRTX Heron Therapeutics Inc.

12.63
+0.36  (+3%)
Previous Close 12.27
Open 12.36
52 Week Low 10.1
52 Week High 22.4
Market Cap $1,287,116,859
Shares 101,909,490
Float 89,086,846
Enterprise Value $1,145,679,303
Volume 672,623
Av. Daily Volume 1,263,974
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Upcoming Catalysts

Drug Stage Catalyst Date
CINVANTI (HTX-019)
Ppostoperative nausea and vomiting (PONV)
NDA Filing
NDA Filing
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Drug Pipeline

Drug Stage Notes
SUSTOL (granisetron)
Prevention of acute- and delayed-onset chemotherapy-induced nausea and vomiting (CINV)
Approved
Approved
CRL Mar 28 2013. Approved August 10 2016.
ZYNRELEF (HTX-011)
Post operative pain
Approved
Approved
FDA approval announced May 13, 2021.
HTX-034
Postoperative Pain
Phase 1/2
Phase 1/2
Phase 2 portion of trial initiated March 2021.
CINVANTI (aprepitant) - (GUARDS-1)
COVID-19
Phase 2
Phase 2
Phase 2 initiation announced July 16, 2020.
HTX-011
Total knee arthroplasty
Phase 3
Phase 3
Phase 3b data released October 3, 2019.
CINVANTI (HTX-019)
Prevention of chemotherapy-induced nausea and vomiting (CINV)
Approved
Approved
FDA additional approval allowing IV injection in addition to current IV infusion.

Latest News

  1. SAN DIEGO, Sept. 21, 2021 /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 that Barry Quart, Pharm.D., Chairman and Chief Executive Officer, and John Poyhonen, President and Chief Commercial Officer, will participate in a fireside chat at the 2021 Cantor Virtual Global Healthcare Conference on Monday, September 27, 2021 at 1:20 pm ET.

    A live webcast of the fireside chat will be available on the Company's website at www.herontx.com in the Investor Resources section. A replay of the event will be archived on the site for 60 days.

    About Heron

    SAN DIEGO, Sept. 21, 2021 /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 that Barry Quart, Pharm.D., Chairman and Chief Executive Officer, and John Poyhonen, President and Chief Commercial Officer, will participate in a fireside chat at the 2021 Cantor Virtual Global Healthcare Conference on Monday, September 27, 2021 at 1:20 pm ET.

    A live webcast of the fireside chat will be available on the Company's website at www.herontx.com in the Investor Resources section. A replay of the event will be archived on the site for 60 days.

    About Heron Therapeutics, Inc.

    Heron Therapeutics, Inc. is 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. Our advanced science, patented technologies, and innovative approach to drug discovery and development have allowed us to create and commercialize a portfolio of products that aim to advance the standard-of-care for acute care and oncology patients. For more information, visit www.herontx.com.

    Forward-Looking Statements 

    This news release contains "forward-looking statements" as defined by the Private Securities Litigation Reform Act of 1995. Heron cautions readers that forward-looking statements are based on management's expectations and assumptions as of the date of this news release and are subject to certain risks and uncertainties that could cause actual results to differ materially. These risks and uncertainties include, but are not limited to, risks and uncertainties identified in the Company's filings with the Securities and Exchange Commission. Forward-looking statements reflect our analysis only on their stated date, and Heron takes no obligation to update or revise these statements except as may be required by law.

    Investor Relations and Media Contact: David Szekeres, Executive Vice President, Chief Operating Officer, Heron Therapeutics, Inc., dszekeres@herontx.com, 858-251-4447

    Cision View original content:https://www.prnewswire.com/news-releases/heron-therapeutics-to-present-at-the-2021-cantor-virtual-global-healthcare-conference-301381949.html

    SOURCE Heron Therapeutics, Inc.

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  2. SAN DIEGO, Aug. 9, 2021 /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 six months ended June 30, 2021 and highlighted recent corporate updates.

    Recent Corporate Updates

    Acute Care Franchise

    • ZYNRELEF Now Available: In May 2021, the U.S. Food and Drug Administration (FDA) approved the Company's New Drug Application (NDA) for ZYNRELEF (bupivacaine and meloxicam) extended-release solution. ZYNRELEF is indicated for use in adults for soft tissue or periarticular instillation to produce postsurgical analgesia…

    SAN DIEGO, Aug. 9, 2021 /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 six months ended June 30, 2021 and highlighted recent corporate updates.

    Recent Corporate Updates

    Acute Care Franchise

    • ZYNRELEF Now Available: In May 2021, the U.S. Food and Drug Administration (FDA) approved the Company's New Drug Application (NDA) for ZYNRELEF (bupivacaine and meloxicam) extended-release solution. ZYNRELEF is indicated 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. ZYNRELEF became commercially available in the U.S. on July 1, 2021. During the initial weeks of commercial launch, the reception to ZYNRELEF has been positive with 61 unique accounts already purchasing the product. The Company has applied for a unique C-code for ZYNRELEF, which would provide 3-year Medicare reimbursement outside the surgical bundle payment for outpatient procedures. In the interim, Medicare will reimburse ZYNRELEF under a miscellaneous C-code. In addition, multiple payers covering over 86 million commercial and Medicaid lives have already agreed to reimburse ZYNRELEF outside the surgical bundle payment for surgeries performed in ambulatory surgical centers, with many of these covered lives also having their hospital outpatient procedures reimbursed outside the surgical bundle payment.
    • NDA for HTX-019 for Prevention of PONV in Adults Planned in Late 2021: A 505(b)(2) NDA for HTX-019 for prevention of postoperative nausea and vomiting (PONV) in adults is on track for filing in late 2021.

    Oncology Care Franchise

    • 2021 Net Product Sales: For the three and six months ended June 30, 2021, oncology care franchise net product sales were $22.4 million and $42.5 million, respectively, compared to $22.7 million and $48.1 million, respectively, for the same periods in 2020. During the second quarter of 2021, the net product sales increased by 12% compared to the prior quarter and this increase was in-line with the 10% to 20% growth anticipated for the quarter. Heron continues to expect growth of the oncology care franchise net product sales, but at a slower rate than originally projected. Key factors influencing our growth rate projections are the lower rate of new cancer patient treatment starts due to the COVID-19 pandemic, fewer clinic anti-emetic administrations during the first half of 2021 compared to the prior year, stronger than expected competition, and the impact of value-based payer reimbursement.
      • CINVANTI® Net Product Sales: Net product sales of CINVANTI (aprepitant) injectable emulsion for the three and six months ended June 30, 2021 were $19.7 million and $38.2 million, respectively, compared to $22.6 million and $47.8 million, respectively, for the same periods in 2020. During the second quarter of 2021, CINVANTI demand units increased by 22% over the prior quarter, which was partially offset by a lower net selling price.
      • SUSTOL® Net Product Sales: Net product sales of SUSTOL (granisetron) extended-release injection for the three and six months ended June 30, 2021 were $2.7 million and $4.3 million, respectively, compared to $0.1 million and $0.3 million, respectively, for the same periods in 2020. During the second quarter of 2021, SUSTOL demand units increased by 108% over the prior quarter, which was partially offset by a lower net selling price.
    • 2021 Oncology Care Franchise Net Product Sales Guidance: Heron currently expects third quarter of 2021 net product sales for the oncology care franchise to increase approximately 5% to 10% compared to the prior quarter. The Company is withdrawing its full-year 2021 net product sales guidance for the oncology care franchise based on the uncertainty associated with the rate of new cancer patient treatment starts and the impact of value-based contracting reimbursement.

    "The reception in the marketplace for ZYNRELEF has been outstanding, with a large number of ordering accounts for the first weeks of a launch. Another important accomplishment in these first weeks of launch has been securing an unprecedented number of commercial and Medicaid payers agreeing to reimburse ZYNRELEF outside the surgical bundled payment. We are currently working with the FDA to determine the requirements to expand the drug's label for use in additional indications," said Barry Quart, Pharm.D., Chairman and Chief Executive Officer of Heron. "For the oncology care franchise, our net product sales for the first half of 2021 were $42.5 million, and we expect sales for CINVANTI and SUSTOL to continue to grow in the second half of the year. In addition, we continue to advance HTX-019 and remain on track to submit an NDA to the FDA for PONV prevention in Q4 2021."

    Financial Results

    Net product sales for the three and six months ended June 30, 2021 were $22.4 million and $42.5 million, respectively, compared to $22.7 million and $48.1 million, respectively, for the same periods in 2020.

    Heron's net loss for the three and six months ended June 30, 2021 was $61.0 million and $113.6 million, or $0.62 per share and $1.20 per share, respectively, compared to $55.2 million and $106.8 million, or $0.61 per share and $1.18 per share, respectively, for the same periods in 2020. Net loss for the three and six months ended June 30, 2021 included non-cash, stock-based compensation expense of $11.2 million and $22.7 million, respectively, compared to $11.1 million and $23.1 million, respectively, for the same periods in 2020.

    As of June 30, 2021, Heron had cash, cash equivalents and short-term investments of $257.7 million, compared to $208.5 million as of December 31, 2020. Net cash used for operating activities for the six months ended June 30, 2021 was $104.9 million, compared to $90.2 million for the same period in 2020. The increase in our net cash used for operating activities was primarily due to changes in working capital to prepare for the launch of ZYNRELEF in July 2021, including manufacturing of commercial inventory. We expect our net cash used for operating activities to moderate later this year.

    About ZYNRELEF for Postoperative Pain

    ZYNRELEF is the first and only dual-acting local anesthetic that delivers a fixed-dose combination of the local anesthetic bupivacaine and a low dose of nonsteroidal anti-inflammatory drug meloxicam. ZYNRELEF is the first modified-release local anesthetic to be classified by FDA as an "extended-release" product because ZYNRELEF is also the first and only extended-release local anesthetic to demonstrate in Phase 3 studies significantly reduced pain and significantly increased proportion of patients requiring no opioids through the first 72 hours following surgery compared to bupivacaine solution, the current standard-of-care local anesthetic for postoperative pain control. ZYNRELEF was approved by the 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. Safety and efficacy have not been established in highly vascular surgeries, such as intrathoracic, large multilevel spinal, and head and neck procedures. In September 2020, the European Commission granted a marketing authorization for ZYNRELEF for the treatment of somatic postoperative pain from small- to medium-sized surgical wounds in adults. As of January 1, 2021, ZYNRELEF is approved in 31 European countries including the countries of the European Union and European Economic Area and the United Kingdom.

    Please see full prescribing information, including Boxed Warning, at www.ZYNRELEF.com.

    About HTX-019 for PONV

    HTX-019 is an IV injectable emulsion formulation designed to directly deliver aprepitant, the active ingredient in EMEND® (aprepitant) capsules, which is the only substance P/neurokinin-1 (NK1) receptor antagonist (RA) to be approved in the U.S. for the prevention of PONV in adults. The FDA-approved dose of oral EMEND is 40 mg for PONV, which is given within 3 hours prior to induction of anesthesia for surgery. In a Phase 1 clinical trial, 32 mg of HTX-019 as a 30-second IV injection was demonstrated to be bioequivalent to oral aprepitant 40 mg.

    About CINVANTI for Chemotherapy Induced Nausea and Vomiting (CINV) Prevention

    CINVANTI, in combination with other antiemetic agents, is indicated in adults for the prevention of acute and delayed nausea and vomiting associated with initial and repeat courses of highly emetogenic cancer chemotherapy (HEC) including high-dose cisplatin as a single-dose regimen, delayed nausea and vomiting associated with initial and repeat courses of moderately emetogenic cancer chemotherapy (MEC) as a single-dose regimen, and nausea and vomiting associated with initial and repeat courses of MEC as a 3-day regimen. CINVANTI is an IV formulation of aprepitant, an NK1 RA. CINVANTI is the first IV formulation to directly deliver aprepitant, the active ingredient in EMEND® capsules. Aprepitant (including its prodrug, fosaprepitant) is the only single-agent NK1 RA to significantly reduce nausea and vomiting in both the acute phase (0–24 hours after chemotherapy) and the delayed phase (24–120 hours after chemotherapy). The FDA-approved dosing administration included in the U.S. prescribing information for CINVANTI is a 30-minute IV infusion or a 2-minute IV injection.

    Please see full prescribing information at www.CINVANTI.com.

    About 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 (MEC) or anthracycline and cyclophosphamide (AC) combination chemotherapy regimens. SUSTOL is an extended-release, injectable 5-hydroxytryptamine type 3 RA that utilizes Heron's Biochronomer® drug delivery technology to maintain therapeutic levels of granisetron for ≥5 days. The SUSTOL global Phase 3 development program was comprised of two, large, guideline-based clinical studies that evaluated SUSTOL's efficacy and safety in more than 2,000 patients with cancer. SUSTOL's efficacy in preventing nausea and vomiting was evaluated in both the acute phase (0–24 hours after chemotherapy) and delayed phase (24–120 hours after chemotherapy).

    Please see full prescribing information at www.SUSTOL.com.

    About Heron Therapeutics, Inc.

    Heron Therapeutics, Inc. is 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. Our advanced science, patented technologies, and innovative approach to drug discovery and development have allowed us to create and commercialize a portfolio of products that aim to advance the standard-of-care for acute care and oncology patients. For more information, visit www.herontx.com.

    Forward-looking Statements

    This news release contains "forward-looking statements" as defined by the Private Securities Litigation Reform Act of 1995. Heron cautions readers that forward-looking statements are based on management's expectations and assumptions as of the date of this news release and are subject to certain risks and uncertainties that could cause actual results to differ materially, including, but not limited to, the timing of the commercial launch of ZYNRELEF in Europe; the potential market opportunities for ZYNRELEF in the U.S. and Europe; the timing and results of studies for the potential expansion of the U.S. label for ZYNRELEF and for the HTX-019 development program; whether the FDA approves ZYNRELEF for additional indications; the timing of the NDA filing and review process for HTX-019; the net product sales guidance for the oncology care franchise; the expected future balances of Heron's cash, cash equivalents and short-term investments; the expected duration over which Heron's cash, cash equivalents and short-term investments balances will fund its operations; the extent of the impact of the ongoing COVID-19 pandemic on our business; and other risks and uncertainties identified in the Company's filings with the U.S. Securities and Exchange Commission. Forward-looking statements reflect our analysis only on their stated date, and Heron takes no obligation to update or revise these statements except as may be required by law.

    Heron Therapeutics, Inc.

    Consolidated Statements of Operations

    (In thousands, except per share amounts)







    Three Months Ended



    Six Months Ended





    June 30,



    June 30,





    2021



    2020



    2021



    2020





    (Unaudited)

    Revenues:

















    Net product sales



    $      22,443



    $        22,668



    $    42,461



    $    48,068

    Operating expenses:

















    Cost of product sales



    14,522



    9,005



    23,729



    19,627

    Research and development



    35,233



    44,004



    73,349



    80,898

    General and administrative



    10,907



    9,819



    20,480



    20,241

    Sales and marketing



    22,250



    15,589



    37,486



    35,785

    Total operating expenses



    82,912



    78,417



    155,044



    156,551

    Loss from operations



    (60,469)



    (55,749)



    (112,583)



    (108,483)

    Other income (expense)



    (546)



    559



    (1,046)



    1,714

    Net loss



    $    (61,015)



    $     (55,190)



    $(113,629)



    $(106,769)

    Basic and diluted net loss per share



    $        (0.62)



    $         (0.61)



    $      (1.20)



    $      (1.18)

    Shares used in computing basic and

    diluted net loss per share



    98,459



    90,753



    94,943



    90,581

     

    Heron Therapeutics, Inc.

    Consolidated Balance Sheets

    (in thousands)







    June 30,

    2021



    December 31,

    2020





    (unaudited)





    ASSETS









    Current assets:









    Cash and cash equivalents



    $          191,173



    $          105,138

    Short-term investments



    66,505



    103,353

    Accounts receivable, net



    42,615



    41,850

    Inventory



    42,800



    41,905

    Prepaid expenses and other current assets



    23,733



    21,950

    Total current assets



    366,826



    314,196

    Property and equipment, net



    22,175



    22,737

    Right-of-use lease assets



    14,903



    16,277

    Other assets



    346



    346

    Total assets



    $          404,250



    $          353,556

    LIABILITIES AND STOCKHOLDERS' EQUITY









    Current liabilities:









    Accounts payable



    $            11,242



    $                 525

    Accrued clinical and manufacturing liabilities



    23,907



    49,962

    Accrued payroll and employee liabilities



    13,681



    13,597

    Other accrued liabilities



    30,151



    28,369

    Current lease liabilities



    3,162



    2,997

    Convertible notes payable to related parties, net of discount





    7,053

    Total current liabilities



    82,143



    102,503

    Non-current lease liabilities



    13,013



    14,561

    Non-current convertible notes payable, net



    148,982



    Total liabilities



    244,138



    117,064











    Stockholders' equity:









    Common stock



    1,019



    913

    Additional paid-in capital



    1,665,429



    1,628,070

    Accumulated other comprehensive income



    41



    257

    Accumulated deficit



    (1,506,377)



    (1,392,748)

    Total stockholders' equity



    160,112



    236,492

    Total liabilities and stockholders' equity



    $          404,250



    $          353,556

     

    Investor Relations and Media Contact:

    David Szekeres

    Executive Vice President, Chief Operating Officer

    Heron Therapeutics, Inc.

    dszekeres@herontx.com 

    858-251-4447

    Cision View original content:https://www.prnewswire.com/news-releases/heron-therapeutics-announces-financial-results-for-the-three-and-six-months-ended-june-30-2021-and-highlights-recent-corporate-updates-301350792.html

    SOURCE Heron Therapeutics, Inc.

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  3. SAN DIEGO, July 28, 2021 /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 the results from the HOPE Hernia-1 study of ZYNRELEF (bupivacaine and meloxicam) in hernia repair surgery have been published online by Pain and Therapy in an article entitled, "Opioid-Free Recovery After Hernia Repair With HTX-011 as the Foundation of a Non-Opioid, Multimodal Analgesia Regimen in a Real-World Setting." In this study, ZYNRELEF, used with scheduled over-the-counter oral analgesics (acetaminophen and ibuprofen) and a personalized opioid prescription algorithm…

    SAN DIEGO, July 28, 2021 /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 the results from the HOPE Hernia-1 study of ZYNRELEF (bupivacaine and meloxicam) in hernia repair surgery have been published online by Pain and Therapy in an article entitled, "Opioid-Free Recovery After Hernia Repair With HTX-011 as the Foundation of a Non-Opioid, Multimodal Analgesia Regimen in a Real-World Setting." In this study, ZYNRELEF, used with scheduled over-the-counter oral analgesics (acetaminophen and ibuprofen) and a personalized opioid prescription algorithm in a real-world environment, enabled more than 90% of patients to be discharged without an opioid prescription, with no callbacks for pain management and 95% of patients to recover opioid-free.

    ZYNRELEF is an extended-release solution of bupivacaine and meloxicam that is indicated 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.

    "Despite efforts to combat the nation's growing opioid crisis, recent evidence suggests that clinical practice is lagging and opioids are still overprescribed after inguinal herniorrhaphy," said Jay Redan, M.D., FACS, Chief of Surgery at Advent Health-Celebration in Celebration, Florida and an author of the publication. "The findings from this study demonstrate the ability of ZYNRELEF to serve as the foundation of non-opioid multimodal analgesia. These data also show ZYNRELEF, in conjunction with an algorithm that distinguishes between patients who need or do not need a discharge opioid prescription, could further increase the proportion of opioid-free patients, decrease the amount of opioids required per patient, and decrease the total number of opioid pills prescribed at discharge after surgery."

    The study, HOPE Hernia-1, is part of the HOPE project, which is designed to provide surgeons with practical real-world solutions to effectively manage postoperative pain and eliminate the need for opioid prescriptions using ZYNRELEF as the foundation of a scheduled non-opioid multimodal analgesic regimen.

    The Pain and Therapy article can be found here.

    Important Safety Information for Patients

    ZYNRELEF contains an NSAID (non-steroidal anti-inflammatory drug), a type of medicine which:

    • can increase the risk of a heart attack or stroke that can lead to death. This risk increases with higher doses and longer use of an NSAID.
    • cannot be used during heart bypass surgery.
    • can increase the risk of gastrointestinal bleeding, ulcers, and tears.

    ZYNRELEF should also not be used if you are allergic to any components of ZYNRELEF, aspirin or other NSAIDs (such as ibuprofen or naproxen), or have had an asthma attack, hives, or other allergic reaction after taking any of these medicines; or as a paracervical block, during childbirth.

    The most common side effects of ZYNRELEF are constipation, vomiting, and headache.

    The medicines in ZYNRELEF (a local anesthetic and an NSAID) can affect the nervous and cardiovascular system; may cause liver or kidney problems; may reduce the effects of some blood pressure medicines; should be avoided if you have severe heart failure; may cause a rare blood disorder, or life-threatening skin or allergic reactions; may harm your unborn baby if received at 20 weeks of pregnancy or later; and may cause low red blood cells (anemia). Please see full Prescribing Information, including Boxed Warning.

    About Helping Opioid Prescription Elimination (HOPE) Study

    The study, Helping Opioid Prescription Elimination Hernia-1 (HOPE Hernia-1), is part of the HOPE project, which is designed to provide surgeons with practical real-world solutions to effectively manage postoperative pain and eliminate the need for opioid prescriptions using a ZYNRELEF-based non-opioid multimodal analgesia (MMA) regimen. All patients received oral ibuprofen 400 mg and acetaminophen 1 g approximately 2 hours before surgery and at the end of surgery all patients received intraoperative ZYNRELEF (300 mg bupivacaine/9 mg meloxicam) administered via needle-free application into the surgical site after final irrigation and suction of fascial layers and prior to suturing. The study randomized patients into two cohorts receiving non-opioid multimodal analgesia regimens – concurrent versus alternating ibuprofen and acetaminophen – following herniorrhaphy. A personalized algorithm determined eligibility for an opioid prescription at discharge: Numeric rating scale (NRS) pain score ≥6 and/or receipt of a postoperative opioid prior to discharge. Key results of the study include the following:

    • The majority of patients (85/93; 91.4%) did not receive an opioid prescription at discharge or at any time through 2 weeks after surgery, and the results were similar between cohorts (alternating MMA, 89.1%; concurrent MMA, 93.6%).
    • Overall, 94.6% of patients were opioid-free through the 2-week follow-up period.
    • The mean discharge time following surgery was 2.6 hours in the alternating MMA cohort and 2.2 hours in the concurrent MMA cohort.
    • Of the 98% of patients who completed the TSQM-9, most patients were "very" or "extremely" satisfied with their MMA regimen.

    ZYNRELEF plus acetaminophen and ibuprofen was well tolerated; safety results were similar between concurrent and alternating MMA cohorts.

    About ZYNRELEFTM for Postoperative Pain

    ZYNRELEF is the first and only dual-acting local anesthetic (DALA) that delivers a fixed-dose combination of the local anesthetic bupivacaine and a low dose of nonsteroidal anti-inflammatory drug meloxicam. ZYNRELEF is the first modified-release local anesthetic to be classified by FDA as an "extended-release" product because ZYNRELEF is also the first and only extended-release local anesthetic to demonstrate in Phase 3 studies significantly reduced pain and significantly increased proportion of patients requiring no opioids through the first 72 hours following surgery compared to bupivacaine solution, the current standard-of-care local anesthetic for postoperative pain control. ZYNRELEF was 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. Safety and efficacy have not been established in highly vascular surgeries, such as intrathoracic, large multilevel spinal, and head and neck procedures. In September 2020, the European Commission (EC) granted a marketing authorization for ZYNRELEF for the treatment of somatic postoperative pain from small- to medium-sized surgical wounds in adults. As of January 1, 2021, ZYNRELEF is approved in 31 European countries including the countries of the European Union and European Economic Area and the United Kingdom.

    About Heron Therapeutics, Inc.

    Heron Therapeutics, Inc. is 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. Our advanced science, patented technologies, and innovative approach to drug discovery and development have allowed us to create and commercialize a portfolio of products that aim to advance the standard-of-care for acute care and oncology patients. For more information, visit www.herontx.com.

    Forward-looking Statements

    This news release contains "forward-looking statements" as defined by the Private Securities Litigation Reform Act of 1995. Heron cautions readers that forward-looking statements are based on management's expectations and assumptions as of the date of this news release and are subject to certain risks and uncertainties that could cause actual results to differ materially, including, but not limited to, the timing of the commercial launch of ZYNRELEF in Europe; the potential market opportunity for ZYNRELEF in the US and Europe; the extent of the impact of the ongoing Coronavirus Disease 2019 pandemic on our business; and other risks and uncertainties identified in the Company's filings with the U.S. Securities and Exchange Commission. Forward-looking statements reflect our analysis only on their stated date, and Heron takes no obligation to update or revise these statements except as may be required by law.

    Investor Relations and Media Contact:

    David Szekeres

    Executive Vice President, Chief Operating Officer

    Heron Therapeutics, Inc.

    dszekeres@herontx.com 

    858-251-4447

    Cision View original content:https://www.prnewswire.com/news-releases/heron-therapeutics-announces-publication-of-results-from-hope-helping-opioid-prescription-elimination-showing-zynrelef-minimizes-the-need-for-opioids-in-a-real-world-setting-with-95-of-patients-experiencing-an-opioid-free-re-301343597.html

    SOURCE Heron Therapeutics, Inc.

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  4. SAN DIEGO, July 21, 2021 /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 the online publication of new analysis evaluating the efficacy and safety of ZYNRELEF (bupivacaine and meloxicam) extended-release solution in adults aged 65 years and older undergoing bunionectomy and hernia repair from the Phase 3 EPOCH 1 and EPOCH 2 studies. The analysis, published in the peer-reviewed journal Pain Management, showed that 58% of bunionectomy and 87% of hernia repair patients aged 65 years and older receiving ZYNRELEF required no opioids to manage their…

    SAN DIEGO, July 21, 2021 /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 the online publication of new analysis evaluating the efficacy and safety of ZYNRELEF (bupivacaine and meloxicam) extended-release solution in adults aged 65 years and older undergoing bunionectomy and hernia repair from the Phase 3 EPOCH 1 and EPOCH 2 studies. The analysis, published in the peer-reviewed journal Pain Management, showed that 58% of bunionectomy and 87% of hernia repair patients aged 65 years and older receiving ZYNRELEF required no opioids to manage their postoperative pain through 72 hours following surgery. Further, throughout the 72-hour period, the mean pain intensity never rose above the mild range.

    ZYNRELEF is an extended-release solution of bupivacaine and meloxicam that is indicated 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 this post-hoc analysis, those 65 years and older who were administered ZYNRELEF used fewer opioids in bunionectomy and herniorrhaphy compared with bupivacaine (7.7 morphine milligram equivalents (MME) vs 15 MME, and 1.7 MME vs 3.5 MME, respectively). Importantly, a greater proportion of patients 65 years and older required no opioids (i.e., opioid-free) through 72 hours (58% vs 25%, and 87% vs 64%, respectively).

    ZYNRELEF was well tolerated in patients 65 years and older, with a safety profile similar to that for bupivacaine. The safety was also similar to patients aged younger than 65 years and to the overall populations in the Phase 3 studies. No local anesthetic systemic toxicity events occurred and serious adverse events were rare with none considered related to ZYNRELEF.

    "Adults ages 65 and over account for approximately half of all surgeries in the United States each year and are commonly prescribed opioids to treat pain following surgery," said Gary M. Oderda, Pharm.D., MPH, Professor, Director Utah Medicaid Drug Regimen Review Center & Director, Pharmacotherapy Outcomes Research Center, and an author of the publication. "In addition, as people age, medications affect them more strongly and are slower to leave their systems, so the side effects of opioids can be severe. This analysis shows ZYNRELEF demonstrated reduction in both pain and the need for opioids in those 65 years and older, which could eliminate the risks of taking opioids without compromising patient care."

    ZYNRELEF is the first and only local anesthetic that has been clinically shown to significantly reduce pain, including severe pain, better than bupivacaine, the current standard-of-care, for up to 72 hours and to significantly reduce or eliminate opioid use in many patients following surgery.  

    The Pain Management article can be found here.

    Important Safety Information for Patients

    ZYNRELEF contains an NSAID (non-steroidal anti-inflammatory drug), a type of medicine which:

    • can increase the risk of a heart attack or stroke that can lead to death. This risk increases with higher doses and longer use of an NSAID.
    • cannot be used during heart bypass surgery.
    • can increase the risk of gastrointestinal bleeding, ulcers, and tears.

    ZYNRELEF should also not be used if you are allergic to any components of ZYNRELEF, aspirin or other NSAIDs (such as ibuprofen or naproxen), or have had an asthma attack, hives, or other allergic reaction after taking any of these medicines; or as a paracervical block, during childbirth.

    The most common side effects of ZYNRELEF are constipation, vomiting, and headache.

    The medicines in ZYNRELEF (a local anesthetic and an NSAID) can affect the nervous and cardiovascular system; may cause liver or kidney problems; may reduce the effects of some blood pressure medicines; should be avoided if you have severe heart failure; may cause a rare blood disorder, or life-threatening skin or allergic reactions; may harm your unborn baby if received at 20 weeks of pregnancy or later; and may cause low red blood cells (anemia). Please see full Prescribing Information, including Boxed Warning.

    About ZYNRELEFTM for Postoperative Pain

    ZYNRELEF is the first and only dual-acting local anesthetic (DALA) that delivers a fixed-dose combination of the local anesthetic bupivacaine and a low dose of nonsteroidal anti-inflammatory drug meloxicam. ZYNRELEF is the first modified-release local anesthetic to be classified by FDA as an "extended-release" product because ZYNRELEF is also the first and only extended-release local anesthetic to demonstrate in Phase 3 studies significantly reduced pain and significantly increased proportion of patients requiring no opioids through the first 72 hours following surgery compared to bupivacaine solution, the current standard-of-care local anesthetic for postoperative pain control. ZYNRELEF was approved by the 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. Safety and efficacy have not been established in highly vascular surgeries, such as intrathoracic, large multilevel spinal, and head and neck procedures. In September 2020, the European Commission granted a marketing authorization for ZYNRELEF for the treatment of somatic postoperative pain from small- to medium-sized surgical wounds in adults. As of January 1, 2021, ZYNRELEF is approved in 31 European countries including the countries of the European Union and European Economic Area and the United Kingdom. For more information visit ZYNRELEF.com

    About Heron Therapeutics, Inc.

    Heron Therapeutics, Inc. is 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. Our advanced science, patented technologies, and innovative approach to drug discovery and development have allowed us to create and commercialize a portfolio of products that aim to advance the standard-of-care for acute care and oncology patients. For more information, visit www.herontx.com.

    Forward-looking Statements

    This news release contains "forward-looking statements" as defined by the Private Securities Litigation Reform Act of 1995. Heron cautions readers that forward-looking statements are based on management's expectations and assumptions as of the date of this news release and are subject to certain risks and uncertainties that could cause actual results to differ materially, including, but not limited to, the timing of the commercial launch of ZYNRELEF in Europe; the potential market opportunity for ZYNRELEF in the US and Europe; the extent of the impact of the ongoing Coronavirus Disease 2019 pandemic on our business; and other risks and uncertainties identified in the Company's filings with the U.S. Securities and Exchange Commission. Forward-looking statements reflect our analysis only on their stated date, and Heron takes no obligation to update or revise these statements except as may be required by law.

    Investor Relations and Media Contact:

    David Szekeres

    Executive Vice President, Chief Operating Officer

    Heron Therapeutics, Inc.

    dszekeres@herontx.com 

    858-251-4447

    Cision View original content:https://www.prnewswire.com/news-releases/heron-therapeutics-announces-publication-showing-reduction-of-pain-and-opioid-use-compared-to-bupivacaine-in-patients-65-and-older-with-zynrelef-301338856.html

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  5. SAN DIEGO, July 6, 2021 /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 that it has executed a contract for ZYNRELEF with Apexus, LLC (Apexus). Apexus is the designated Prime Vendor for the 340B Drug Pricing Program. ZYNRELEF was approved by the U.S. Food and Drug Administration (FDA) on May 12, 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. ZYNRELEF is the first and only extended-release dual-acting…

    SAN DIEGO, July 6, 2021 /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 that it has executed a contract for ZYNRELEF with Apexus, LLC (Apexus). Apexus is the designated Prime Vendor for the 340B Drug Pricing Program. ZYNRELEF was approved by the U.S. Food and Drug Administration (FDA) on May 12, 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. ZYNRELEF is the first and only extended-release dual-acting local anesthetic and has been clinically shown to better manage pain, including severe pain, compared to standard-of-care bupivacaine over 72 hours and to significantly reduce or eliminate opioid use in many patients following surgery.

    The 340B Drug Pricing Program provides drug discounts to hospitals and clinics serving vulnerable communities. The 340B Drug Pricing Program allows 340B healthcare providers to stretch limited federal resources to reduce the price of outpatient pharmaceuticals for patients and expand health services to the patients and communities they serve. 

    Under the agreement, Heron and the Prime Vendor Program, managed by Apexus, will collaborate to lower drug pricing for participating covered entities. The two organizations are working together to assure that covered entities have access to safe and effective non-opioid postoperative pain management.

    "More than 90,000 Americans died of drug overdoses over the 12-month period that ended in September 2020, surpassing the yearly totals from any year since the opioid epidemic began in the 1990s," said Barry Quart, Pharm.D., Chairman and Chief Executive Officer of Heron. "Ensuring ZYNRELEF is widely available to healthcare providers at an affordable price is a critical next to step to reducing exposure to opioids in the surgical setting and to decreasing the number of unused opioids available for potential misuse."

    As the Prime Vendor, Apexus contracts with manufacturers and distributors to help ensure access to discounted medications. Since 2004, the Prime Vendor Program has brought more than 40,000 covered entities lower 340B drug pricing and additional discounts for those who need it most.

    "We are pleased to work alongside Heron to improve patient care by increasing access to ZYNRELEF, a non-opioid option that has been clinically shown to manage postoperative pain for up to 72 hours after surgery," said Chris Hatwig, President of Apexus.

    Indication

    ZYNRELEF is approved for use in adults to reduce pain for up to 3 days after removal of bunions, groin hernia repair, and total knee replacement. ZYNRELEF is applied into the wound at the time of surgery.

    Important Safety Information

    ZYNRELEF contains an NSAID (non-steroidal anti-inflammatory drug), a type of medicine which:

    • can increase the risk of a heart attack or stroke that can lead to death. This risk increases with higher doses and longer use of an NSAID.
    • cannot be used during heart bypass surgery.
    • can increase the risk of gastrointestinal bleeding, ulcers, and tears.

    ZYNRELEF should also not be used:

    • if you are allergic to any components of ZYNRELEF, aspirin or other NSAIDs (such as ibuprofen or naproxen), or have had an asthma attack, hives, or other allergic reaction after taking any of these medicines.
    • as a paracervical block, during childbirth.

    The most common side effects of ZYNRELEF are constipation, vomiting, and headache.

    The medicines in ZYNRELEF (a local anesthetic and an NSAID) can affect the nervous and cardiovascular system; may cause liver or kidney problems; may reduce the effects of some blood pressure medicines; should be avoided if you have severe heart failure; may cause a rare blood disorder, or life-threatening skin or allergic reactions; may harm your unborn baby if received at 20 weeks of pregnancy or later; and may cause low red blood cells (anemia).

    Tell your healthcare provider about all your medical conditions and about all the medicines you take including prescription or over-the-counter medicines, vitamins, or herbal supplements to discuss if ZYNRELEF is right for you. 

    Talk to your healthcare provider for medical advice about side effects. Report side effects to Heron at 1-844-437-6611 or to FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

    The information provided here is not comprehensive. Please see full Prescribing Information, including Boxed Warning.

    About ZYNRELEF for Postoperative Pain

    ZYNRELEF is the first and only dual-acting local anesthetic (DALA) that delivers a fixed-dose combination of the local anesthetic bupivacaine and a low dose of nonsteroidal anti-inflammatory drug meloxicam. ZYNRELEF is the first modified-release local anesthetic to be classified by FDA as an "extended-release" product because ZYNRELEF is also the first and only extended-release local anesthetic to demonstrate in Phase 3 studies significantly reduced pain and significantly increased proportion of patients requiring no opioids through the first 72 hours following surgery compared to bupivacaine solution, the current standard-of-care local anesthetic for postoperative pain control. ZYNRELEF was approved by the FDA on May 12, 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. Safety and efficacy have not been established in highly vascular surgeries, such as intrathoracic, large multilevel spinal, and head and neck procedures. In September 2020, the European Commission granted a marketing authorization for ZYNRELEF for the treatment of somatic postoperative pain from small- to medium-sized surgical wounds in adults. As of January 1, 2021, ZYNRELEF is approved in 31 European countries including the countries of the European Union and European Economic Area and the United Kingdom. For more information visit ZYNRELEF.com

    About Heron Therapeutics, Inc.

    Heron Therapeutics, Inc. is 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. Our advanced science, patented technologies, and innovative approach to drug discovery and development have allowed us to create and commercialize a portfolio of products that aim to advance the standard-of-care for acute care and oncology patients. For more information, visit www.herontx.com.

    About Apexus

    The 340B Prime Vendor Program, managed by Apexus™, is a contract awarded by the Health Resources and Services Administration (HRSA), which is responsible for administering the 340B Drug Pricing Program. As the Prime Vendor, Apexus contracts with manufacturers and distributors to help ensure access to discounted medications, provides 340B education to all stakeholders, and helps support program integrity through technical assistance.

    Forward-looking Statements

    This news release contains "forward-looking statements" as defined by the Private Securities Litigation Reform Act of 1995. Heron cautions readers that forward-looking statements are based on management's expectations and assumptions as of the date of this news release and are subject to certain risks and uncertainties that could cause actual results to differ materially, including, but not limited to, the potential market opportunity for ZYNRELEF in the U.S.; the extent of the impact of the ongoing Coronavirus Disease 2019 pandemic on our business; and other risks and uncertainties identified in the Company's filings with the U.S. Securities and Exchange Commission. Forward-looking statements reflect our analysis only on their stated date, and Heron takes no obligation to update or revise these statements except as may be required by law.

    Investor Relations and Media Contact:

    David Szekeres

    Executive Vice President, Chief Operating Officer

    Heron Therapeutics, Inc.

    dszekeres@herontx.com 

    858-251-4447

     

    Cision View original content:https://www.prnewswire.com/news-releases/heron-therapeutics-announces-340b-prime-vendor-contract-with-apexus-for-zynrelef-301325202.html

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