HRTX Heron Therapeutics Inc.

17.12
-0.42  -2%
Previous Close 17.54
Open 17.46
52 Week Low 9.6
52 Week High 26.81
Market Cap $1,555,441,948
Shares 90,855,254
Float 74,647,907
Enterprise Value $1,356,667,945
Volume 747,399
Av. Daily Volume 774,808
Stock charts supplied by TradingView

Drug Pipeline

Drug Stage Notes
HTX-011
Post operative pain
NDA Filing
NDA Filing
CRL announced June 29, 2020. NDA resubmission announced November 13, 2020.
CINVANTI (aprepitant) - (GUARDS-1)
COVID-19
Phase 2
Phase 2
Phase 2 initiation announced July 16, 2020.
HTX-034
Postoperative Pain
Phase 1/2
Phase 1/2
Phase 1b/2 trial initiation announced May 18, 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.
APF530 - Sustol
Prevention of acute- and delayed-onset chemotherapy-induced nausea and vomiting (CINV)
Approved
Approved
CRL Mar 28 2013. Approved August 10 2016.

Latest News

  1. SAN DIEGO, Nov. 13, 2020 /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 the New Drug Application (NDA) was resubmitted to the U.S. Food and Drug Administration (FDA) for HTX-011, an investigational agent for the management of postoperative pain.

    The NDA for HTX-011 was resubmitted based on the outcome and final minutes of a Type A End-of-Review meeting with the FDA in September, which was conducted to obtain clarity on the information needed to address the Complete Response Letter (CRL) issued by the FDA in June 2020. The CRL stated…

    SAN DIEGO, Nov. 13, 2020 /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 the New Drug Application (NDA) was resubmitted to the U.S. Food and Drug Administration (FDA) for HTX-011, an investigational agent for the management of postoperative pain.

    The NDA for HTX-011 was resubmitted based on the outcome and final minutes of a Type A End-of-Review meeting with the FDA in September, which was conducted to obtain clarity on the information needed to address the Complete Response Letter (CRL) issued by the FDA in June 2020. The CRL stated that the FDA is unable to approve the NDA in its present form based on the need for additional non-clinical information. There are four non-clinical issues in the CRL, three relate to confirming exposure of excipients in preclinical reproductive toxicology studies and the fourth relates to changing the manufacturing release specification of the allowable level of an impurity based on animal toxicology coverage. Since receiving the CRL, Heron generated data showing that peak plasma levels (Cmax) of excipients in reproductive toxicology studies are >50- to >200-fold higher than the levels observed in patients receiving the highest dose of HTX-011. These results provide validation of the previously submitted animal studies. At the Type A End-of-Review meeting in September, the FDA agreed with the change to the manufacturing specification proposed by Heron to address their concern. The FDA indicated at the Type A End-of-Review meeting that the submission will be classified as a Class 2 resubmission, which means that the FDA can take up to 6 months to review the new information included in the NDA resubmission.

    "We are pleased to have resubmitted the NDA for HTX-011, which we believe fully addresses the CRL based on advice from the FDA," said Barry Quart, Pharm.D., Chairman and Chief Executive Officer of Heron. "In our resubmission, we provided compelling evidence responding to the issues identified in the CRL that should provide the basis for the approval of the HTX-011 NDA. Heron remains committed to bringing HTX-011 to patients and we look forward to working with the FDA to achieve this goal."

    About HTX-011 for Postoperative Pain (ZYNRELEFTM in the European Union and European Economic Area)

    HTX-011, an investigational non-opioid analgesic, is a dual-acting, fixed-dose combination of the local anesthetic bupivacaine with a low dose of the nonsteroidal anti-inflammatory drug meloxicam. It is the first and only extended-release local anesthetic to demonstrate in Phase 3 studies significantly reduced pain and opioid use through 72 hours compared to bupivacaine solution, the current standard-of-care local anesthetic for postoperative pain control. The FDA granted Breakthrough Therapy designation to HTX-011 and the NDA received Priority Review designation. A CRL was received from the FDA regarding the NDA for HTX-011 in June 2020 relating to non-clinical information. No clinical safety or efficacy issues and no chemistry, manufacturing and controls issues were identified. Heron's New Drug Submission (NDS) for HTX-011 for the management of postoperative pain was accepted by Health Canada. Heron is working to respond to a list of questions received from Health Canada in July 2020. In September 2020, the European Commission (EC) granted a marketing authorization for ZYNRELEF (also known as HTX-011) for the treatment of somatic postoperative pain from small- to medium-sized surgical wounds in adults. The EC's centralized marketing authorization is valid for the 27 countries that are members of the European Union, and the other countries in the European Economic Area.

    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. Heron is developing novel, patient-focused solutions that apply its innovative science and technologies to already-approved pharmacological agents for patients suffering from pain or cancer. 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, those associated with: whether the FDA approves the NDA for HTX-011; the timing of the commercial launch of HTX-011 in the U.S.; the timing of the commercial launch of ZYNRELEF in Europe; the timing of Health Canada's NDS review process for HTX-011; whether Health Canada issues a Notice of Compliance for the NDS for HTX-011; 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.

    Investor Relations Contact:

    David Szekeres

    EVP, Chief Operating Officer

    Heron Therapeutics, Inc.

     

    858-251-4447

    Cision View original content:http://www.prnewswire.com/news-releases/heron-therapeutics-resubmits-new-drug-application-to-fda-for-htx-011-for-the-treatment-of-postoperative-pain-301172545.html

    SOURCE Heron Therapeutics, Inc.

    View Full Article Hide Full Article
  2. SAN DIEGO, Nov. 11, 2020 /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 of Heron Therapeutics, will present at the following virtual investor conferences:

    • Stifel 2020 Virtual Healthcare Conference: Tuesday, November 17, 2020 at 3:20 pm ET
    • Jefferies Virtual London Healthcare Conference: Thursday, November 19, 2020 at 1:30 pm GMT
    • 3rd Annual Evercore ISI HealthCONx Conference: Tuesday, December 1, 2020 at 4:20 pm ET

    A live webcast of each presentation will be available on the Company's…

    SAN DIEGO, Nov. 11, 2020 /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 of Heron Therapeutics, will present at the following virtual investor conferences:

    • Stifel 2020 Virtual Healthcare Conference: Tuesday, November 17, 2020 at 3:20 pm ET
    • Jefferies Virtual London Healthcare Conference: Thursday, November 19, 2020 at 1:30 pm GMT
    • 3rd Annual Evercore ISI HealthCONx Conference: Tuesday, December 1, 2020 at 4:20 pm ET

    A live webcast of each presentation will be available on the Company's website at www.herontx.com in the Investor Resources section. A replay of each presentation 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. Heron is developing novel, patient-focused solutions that apply its innovative science and technologies to already-approved pharmacological agents for patients suffering from pain or cancer. 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.

     

    858-251-4447

    Cision View original content:http://www.prnewswire.com/news-releases/heron-therapeutics-to-present-at-several-upcoming-virtual-investor-conferences-301171239.html

    SOURCE Heron Therapeutics, Inc.

    View Full Article Hide Full Article
  3. SAN DIEGO, Nov. 5, 2020 /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 nine months ended September 30, 2020 and highlighted recent corporate updates.

    Recent Corporate Updates

    Pain Management Franchise

    • European Commission Authorization for ZYNRELEF™ for the Treatment of Postoperative Pain: In September 2020, the European Commission (EC) granted a marketing authorization for ZYNRELEF (formerly known as HTX-011) for the treatment of somatic postoperative pain from small- to medium-sized surgical wounds in…

    SAN DIEGO, Nov. 5, 2020 /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 nine months ended September 30, 2020 and highlighted recent corporate updates.

    Recent Corporate Updates

    Pain Management Franchise

    • European Commission Authorization for ZYNRELEF™ for the Treatment of Postoperative Pain: In September 2020, the European Commission (EC) granted a marketing authorization for ZYNRELEF (formerly known as HTX-011) for the treatment of somatic postoperative pain from small- to medium-sized surgical wounds in adults. The marketing authorization follows the European Medicines Agency's positive opinion from the Committee for Medicinal Products for Human Use in July 2020. The EC's centralized marketing authorization is valid for the 27 countries that are members of the European Union (EU), and the other countries in the European Economic Area (EEA). We are currently assessing the evolving global environment for pharmaceuticals and developing a coordinated global marketing strategy, and at this time we anticipate making ZYNRELEF available to patients in Europe during the second half of 2021.



    • Successful Outcome of FDA Type A Meeting to Discuss HTX-011 for the Management of Postoperative Pain: In September 2020, we announced a successful Type A meeting with the U.S. Food and Drug Administration (FDA) in which alignment was reached on the plans for Heron to resubmit the New Drug Application (NDA) for HTX-011 for the management of postoperative pain in the fourth quarter of 2020.

    CINV Franchise

    • CINV Net Product Sales: For the three and nine months ended September 30, 2020, chemotherapy–induced nausea and vomiting (CINV) franchise net product sales were $20.0 million and $68.0 million, respectively, compared to $42.6 million and $110.9 million, respectively, for the same periods in 2019.





      • CINVANTI® Net Product Sales: Net product sales of CINVANTI (aprepitant) injectable emulsion for the three and nine months ended September 30, 2020 were $19.8 million and $67.6 million, respectively, compared to $36.4 million and $97.6 million, respectively, for the same periods in 2019. Heron expects the impact of the generic arbitrage to be resolved in 2020, with a return to growth in 2021 and beyond.



      • SUSTOL® Net Product Sales: Net product sales of SUSTOL (granisetron) extended–release injection for the three and nine months ended September 30, 2020 were $0.2 million and $0.4 million, respectively, compared to $6.2 million and $13.3 million, respectively, for the same periods in 2019. On October 1, 2019, the Company discontinued all discounting of SUSTOL, which resulted in significantly lower SUSTOL net product sales. Heron expects SUSTOL to return to growth in 2021 and beyond.



    • 2020 Net Product Sales Guidance: Although Heron anticipates a decrease in new diagnoses and chemotherapy patient starts because of the ongoing COVID-19 pandemic (COVID-19), the Company has increased its 2020 guidance for net product sales for the CINV franchise from a range of $70 million to $80 million to net product sales of $85 million.

    "The third quarter was highlighted by the authorization of ZYNRELEF in the EU and we remain focused on resubmitting the New Drug Application for HTX-011 in the U.S. as quickly as possible in order to bring this innovative non-opioid medicine to patients suffering from postoperative pain," said Barry Quart, Pharm.D., Chairman and Chief Executive Officer of Heron. "In addition, our CINV franchise is advancing well, with continued strong performance of CINVANTI against a backdrop of arbitrage and the ongoing global pandemic. Based on the strong commercial execution, we are very pleased to increase our guidance for 2020 to $85 million in net product sales."

    Financial Results

    Net product sales for the three and nine months ended September 30, 2020 were $20.0 million and $68.0 million, respectively, compared to $42.6 million and $110.9 million, respectively, for the same periods in 2019.

    Heron's net loss for the three and nine months ended September 30, 2020 was $58.2 million and $165.0 million, or $0.64 per share and $1.82 per share, respectively, compared to $33.6 million and $146.8 million, or $0.42 per share and $1.85 per share, respectively, for the same periods in 2019. Net loss for the three and nine months ended September 30, 2020 included non-cash, stock-based compensation expense of $11.1 million and $34.2 million, respectively, compared to $9.7 million and $40.3 million, respectively, for the same periods in 2019.

    As of September 30, 2020, Heron had cash, cash equivalents and short-term investments of $258.1 million, compared to $391.0 million as of December 31, 2019. Net cash used for operating activities for the nine months ended September 30, 2020 was $132.3 million, compared to $97.6 million for the same period in 2019. Heron expects that its current cash, cash equivalents and short-term investments will be sufficient to fund its operations into 2022.

    About HTX-011 for Postoperative Pain (ZYNRELEF in the EU and EEA)

    HTX-011, an investigational non-opioid analgesic, is a dual-acting, fixed-dose combination of the local anesthetic bupivacaine with a low dose of the nonsteroidal anti-inflammatory drug meloxicam. It is the first and only extended-release local anesthetic to demonstrate in Phase 3 studies significantly reduced pain and opioid use through 72 hours compared to bupivacaine solution, the current standard-of-care local anesthetic for postoperative pain control. The FDA granted Breakthrough Therapy designation to HTX-011 and the NDA received Priority Review designation. A complete response letter (CRL) was received from the FDA regarding the NDA for HTX-011 in June 2020 relating to non clinical information. No clinical safety or efficacy issues and no chemistry, manufacturing and controls issues were identified. Heron's New Drug Submission (NDS) for HTX-011 for the management of postoperative pain was accepted by Health Canada. Heron is working to respond to a list of questions received from Health Canada in July 2020. In September 2020, the EC granted a marketing authorization for ZYNRELEF (also known as HTX-011) for the treatment of somatic postoperative pain from small- to medium-sized surgical wounds in adults. The EC's centralized marketing authorization is valid for the 27 countries that are members of the EU, and the other countries in the EEA.

    About CINVANTI (Aprepitant) Injectable Emulsion

    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, a substance P/neurokinin-1 (NK1) receptor antagonist (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 United States prescribing information for CINVANTI is a 30-minute IV infusion or a 2-minute IV injection.

    CINVANTI is under investigation for the treatment of COVID-19 as a daily 2-minute IV injection when added to the current standard of care.

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

    About SUSTOL (Granisetron) Extended-Release Injection

    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-HT3 receptor antagonist 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. Heron is developing novel, patient-focused solutions that apply its innovative science and technologies to already-approved pharmacological agents for patients suffering from pain or cancer. 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, those associated with: the timing of the NDA resubmission to the FDA; whether the FDA approves the NDA for HTX-011; the timing of the commercial launch of HTX-011 in the U.S.; the timing of the commercial launch of ZYNRELEF in Europe; the timing of Health Canada's NDS review process for HTX-011; whether Health Canada issues a Notice of Compliance for the NDS for HTX-011; the full-year 2020 net product sales guidance for the CINV 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.

    Condensed Consolidated Balance Sheets

    (In thousands)







    September 30,

    2020



    December 31,

    2019





    (Unaudited)





    ASSETS













    Current assets:













    Cash and cash equivalents



    $

    95,141



    $

    71,898

    Short-term investments





    163,005





    319,074

    Accounts receivable, net





    33,654





    39,879

    Inventory





    42,749





    24,968

    Prepaid expenses and other current assets





    16,446





    23,245

    Total current assets





    350,995





    479,064

    Property and equipment, net





    21,741





    19,618

    Right-of-use lease assets





    16,941





    13,754

    Other assets





    346





    346

    Total assets



    $

    390,023



    $

    512,782

    LIABILITIES AND STOCKHOLDERS' EQUITY













    Current liabilities:













    Accounts payable



    $

    12,067



    $

    2,758

    Accrued clinical and manufacturing liabilities





    40,718





    34,614

    Accrued payroll and employee liabilities





    13,235





    15,248

    Other accrued liabilities





    22,009





    36,535

    Current lease liabilities





    2,912





    1,926

    Convertible notes payable to related parties, net of discount





    6,637





    5,624

    Total current liabilities





    97,578





    96,705

    Non-current lease liabilities





    15,298





    12,242

    Total liabilities





    112,876





    108,947

    Stockholders' equity:













    Common stock





    909





    903

    Additional paid-in capital





    1,606,165





    1,568,317

    Accumulated other comprehensive income





    540





    85

    Accumulated deficit





    (1,330,467)





    (1,165,470)

    Total stockholders' equity





    277,147





    403,835

    Total liabilities and stockholders' equity



    $

    390,023



    $

    512,782

     

    HERON THERAPEUTICS, INC.

    Condensed Consolidated Statements of Operations

    (In thousands, except per share amounts)







    Three Months Ended

    September 30,



    Nine Months Ended

    September 30,





    2020



    2019



    2020



    2019





    (unaudited)

    Revenues:

























    Net product sales



    $

    19,965



    $

    42,624



    $

    68,033



    $

    110,885

    Operating expenses:

























    Cost of product sales





    7,170





    17,195





    26,797





    45,745

    Research and development





    49,182





    34,708





    130,080





    119,105

    General and administrative





    9,482





    8,597





    29,723





    28,023

    Sales and marketing





    12,515





    16,977





    48,300





    69,344

    Total operating expenses





    78,349





    77,477





    234,900





    262,217

    Loss from operations





    (58,384)





    (34,853)





    (166,867)





    (151,332)

    Other income, net





    156





    1,258





    1,870





    4,503

    Net loss



    $

    (58,228)



    $

    (33,595)



    $

    (164,997)



    $

    (146,829)



























    Basic and diluted net loss per share



    $

    (0.64)



    $

    (0.42)



    $

    (1.82)



    $

    (1.85)



























    Shares used in computing basic and diluted net loss per share





    90,849





    79,940





    90,671





    79,308

     

    HERON THERAPEUTICS, INC.

    Condensed Consolidated Statements of Cash Flows

    (In thousands)







    Nine Months Ended

    September 30,





    2020



    2019





    (unaudited)

    Operating activities:













    Net loss



    $

    (164,997)



    $

    (146,829)

    Adjustments to reconcile net loss to net cash used for operating activities:













    Stock-based compensation expense





    34,183





    40,312

    Depreciation and amortization





    2,135





    1,480

    Amortization of debt discount





    1,013





    780

    Realized gain on available-for-sale securities









    (8)

    Amortization of premium (accretion of discount) on short-term investments





    39





    (3,264)

    Impairment of property and equipment





    61





    80

    Loss on disposal of property and equipment









    53

    Change in operating assets and liabilities:













    Accounts receivable





    6,225





    (2,303)

    Inventory





    (17,781)





    14,860

    Prepaid expenses and other assets





    6,799





    (5,549)

    Accounts payable





    9,309





    (15,236)

    Accrued clinical and manufacturing liabilities





    6,104





    1,603

    Accrued payroll and employee liabilities





    (2,013)





    (3,263)

    Other accrued liabilities





    (13,343)





    19,681

    Net cash used for operating activities





    (132,266)





    (97,603)

    Investing activities:













    Purchases of short-term investments





    (92,040)





    (287,579)

    Maturities and sales of short-term investments





    248,525





    395,406

    Purchases of property and equipment





    (4,319)





    (3,251)

    Net cash provided by investing activities





    152,166





    104,576

    Financing activities:













    Net proceeds from sale of common stock









    (110)

    Proceeds from stock option exercises





    1,833





    20,239

    Proceeds from purchases under the Employee Stock Purchase Plan





    1,507





    1,170

    Proceeds from warrant exercises





    3





    Net cash provided by financing activities





    3,343





    21,299

    Net increase in cash and cash equivalents





    23,243





    28,272

    Cash and cash equivalents at beginning of year





    71,898





    31,836

    Cash and cash equivalents at end of period



    $

    95,141



    $

    60,108

    Investor Relations and Media Contact:

    David Szekeres

    EVP, Chief Operating Officer

    Heron Therapeutics, Inc.

     

    858-251-4447

    Cision View original content:http://www.prnewswire.com/news-releases/heron-therapeutics-announces-financial-results-for-the-three-and-nine-months-ended--september-30-2020-and-highlights-recent-corporate-updates-301166525.html

    SOURCE Heron Therapeutics, Inc.

    View Full Article Hide Full Article
  4. SAN DIEGO, Sept. 28, 2020 /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 the European Commission has granted a marketing authorization for ZYNRELEF (formerly known as HTX-011) for the treatment of somatic postoperative pain from small- to medium-sized surgical wounds in adults. The marketing authorization follows the European Medicines Agency's (EMA) positive opinion from the Committee for Medicinal Products for Human Use (CHMP) in July 2020. Heron currently expects to make ZYNRELEF available to patients in the European Union (EU) during…

    SAN DIEGO, Sept. 28, 2020 /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 the European Commission has granted a marketing authorization for ZYNRELEF (formerly known as HTX-011) for the treatment of somatic postoperative pain from small- to medium-sized surgical wounds in adults. The marketing authorization follows the European Medicines Agency's (EMA) positive opinion from the Committee for Medicinal Products for Human Use (CHMP) in July 2020. Heron currently expects to make ZYNRELEF available to patients in the European Union (EU) during 2021.

    ZYNRELEF is a non-opioid, dual-acting analgesic, utilizing a fixed-dose combination of the local anesthetic bupivacaine with a low dose of the nonsteroidal anti-inflammatory drug meloxicam. For approximately 72 hours after ZYNRELEF is applied into the surgical site, ZYNRELEF releases bupivacaine and meloxicam, which are then absorbed into the surrounding tissues. Meloxicam potentiates the effect of bupivacaine, resulting in an increase in analgesia.

    The European Commission's authorization of ZYNRELEF is based on the results of Heron's two multi-center, double-blind, active and placebo-controlled Phase 3 studies of ZYNRELEF. The primary endpoint and all 4 key secondary endpoints were met in both Phase 3 studies. ZYNRELEF demonstrated significantly reduced pain and opioid use through 72 hours compared to saline placebo and to bupivacaine solution, the current standard-of-care local anesthetic for postoperative pain control. ZYNRELEF also significantly increased the proportion of patients who required no postoperative opioids. The most common side effect with ZYNRELEF is dizziness.

    The European Commission's centralized marketing authorization is valid for the 27 countries that are members of the EU and the United Kingdom. Norway, Iceland and Liechtenstein will make corresponding decisions based on the decision of the European Commission.

    "The authorization of ZYNRELEF in the EU is an important milestone for Heron, as well as for the millions of surgical patients in the EU for whom safety, pain relief and recovery are of primary importance," said Barry Quart, Pharm.D., President and Chief Executive Officer of Heron. "With a novel dual mechanism of action, and single, needle-free application, ZYNRELEF has been clinically shown to better manage severe pain than standard-of-care bupivacaine over 72 hours and we believe that ZYNRELEF adds an effective therapeutic option for the management of postoperative pain for eligible patients."



    About ZYNRELEF (Approved in the European Union)

    ZYNRELEF, a non-opioid analgesic, is a dual-acting, fixed-dose combination of the local anesthetic bupivacaine with a low dose of the nonsteroidal anti-inflammatory drug meloxicam. It is the first and only extended-release local anesthetic to demonstrate in Phase 3 studies significantly reduced pain and opioid use through 72 hours compared to saline placebo and to bupivacaine solution, the current standard-of-care local anesthetic for postoperative pain control. ZYNRELEF is indicated for the treatment of somatic postoperative pain from small- to medium-sized surgical wounds in adults. Efficacy and safety have not been established in major surgeries, including abdominal, vascular and thoracic surgeries. ZYNRELEF should be administered in a setting where trained personal and equipment are available to ensure prompt treatment of any toxic neurological or cardiac effects. ZYNRELEF received authorization from the European Commission in September 2020.

    About HTX-011 for Postoperative Pain

    HTX-011, an investigational non-opioid analgesic, is a dual-acting, fixed-dose combination of the local anesthetic bupivacaine with a low dose of the nonsteroidal anti-inflammatory drug meloxicam. It is the first and only extended-release local anesthetic to demonstrate in Phase 3 studies significantly reduced pain and opioid use through 72 hours compared to bupivacaine solution, the current standard-of-care local anesthetic for postoperative pain control. The U.S. Food and Drug Administration (FDA) granted Breakthrough Therapy designation to HTX-011 and the New Drug Application (NDA) received Priority Review designation. A complete response letter (CRL) was received from the FDA regarding the NDA for HTX-011 in June 2020 relating to non–clinical information. No clinical safety or efficacy issues and no chemistry, manufacturing and controls (CMC) issues were identified. Heron's New Drug Submission (NDS) for HTX-011 for the management of postoperative pain was granted Priority Review status and accepted by Health Canada. Heron is working to respond to a list of questions received from Health Canada in July 2020.

    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. Heron is developing novel, patient-focused solutions that apply its innovative science and technologies to already-approved pharmacological agents for patients suffering from pain or cancer. 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, those associated with: the timing of the NDA resubmission to the FDA; whether the FDA approves the NDA for HTX-011; the timing of the commercial launch of HTX-011 in the U.S.; the timing of the commercial launch of ZYNRELEF in Europe; the timing of Health Canada's NDS review process for HTX-011; whether Health Canada issues a Notice of Compliance for the NDS for HTX-011; the extent of the impact of the ongoing Coronavirus Disease 2019 (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.

    Investor Relations Contact:

    David Szekeres

    Chief Legal, Business and Administrative Officer

    Heron Therapeutics, Inc.



    858-251-4447

    Cision View original content:http://www.prnewswire.com/news-releases/heron-therapeutics-receives-european-commission-authorization-for-zynrelef-htx-011-for-the-treatment-of-postoperative-pain-301138692.html

    SOURCE Heron Therapeutics, Inc.

    View Full Article Hide Full Article
  5. SAN DIEGO, Sept. 16, 2020 /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 the results from EPOCH 2 follow-on study (NCT03695367) of the investigational agent HTX-011 in open inguinal hernia repair surgery with mesh, have been published online by the journal, Surgery in an article entitled "Opioid-free recovery following herniorrhaphy with HTX-011 as the foundation of a multimodal analgesic regimen." In this study, more than 90% of patients receiving HTX-011, along with postoperative over-the-counter (OTC) acetaminophen and ibuprofen…

    SAN DIEGO, Sept. 16, 2020 /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 the results from EPOCH 2 follow-on study (NCT03695367) of the investigational agent HTX-011 in open inguinal hernia repair surgery with mesh, have been published online by the journal, Surgery in an article entitled "Opioid-free recovery following herniorrhaphy with HTX-011 as the foundation of a multimodal analgesic regimen." In this study, more than 90% of patients receiving HTX-011, along with postoperative over-the-counter (OTC) acetaminophen and ibuprofen, remained opioid-free throughout the 72-hour period following hernia repair surgery. The mean pain intensity never rose above the mild range through 72 hours following surgery.

    HTX-011 is a dual-acting, fixed-dose combination of the local anesthetic bupivacaine with a low dose of the nonsteroidal anti-inflammatory drug meloxicam. It is the first and only extended–release local anesthetic to demonstrate in Phase 3 studies (EPOCH 1 in bunionectomy and EPOCH 2 in hernia repair) significantly reduced pain and opioid use through 72 hours compared to bupivacaine solution, the current standard–of–care local anesthetic for postoperative pain control. HTX-011 was well tolerated, with a safety profile comparable to placebo and bupivacaine solution.

    "Typically, the first 72 hours after surgery are the most difficult from a pain management perspective and is where patients experience the most severe pain requiring opioids," said Jay Redan, M.D., Chief of Surgery at AdventHealth Celebration. "The EPOCH 2 follow-on study provides important evidence that HTX-011, along with OTC analgesics, can keep patients in the mild pain range, allowing more than 90% to remain opioid-free. The study was able to identify patients who should receive an opioid discharge prescription and has the potential to personalize postoperative pain management so that opioids are only prescribed to those who will need them after discharge. This can help to substantially limit the amount of opioids going home with patients following hernia repair surgery."

    The Surgery article can be found here.

    About the EPOCH 2 Follow-On Study

    The EPOCH 2 follow-on study was a multicenter, postoperative pain management study evaluating the efficacy and safety of locally administered HTX-011 300 mg bupivacaine / 9 mg meloxicam via needle-free application into the surgical site in combination with a postoperative non-opioid multimodal analgesia (MMA) regimen of over-the-counter oral acetaminophen and ibuprofen in 63 patients. The study included two sequential cohorts, with identical procedures and MMA regimens, except that patients in Cohort 2 also received an intraoperative dose of ketorolac (15 mg or 30 mg, based on age, renal function and weight) prior to wound closure. The goal was to increase the proportion of opioid-free patients by combining HTX-011 with a postoperative regimen of readily available, oral analgesics. Key results of the study include the following:

    • In total, more than 90% of patients in this study did not require opioids to manage their postoperative pain during the first 72 hours.
    • Across all study patients, 87% were opioid-free through Day 10 and 83% were opioid-free throughout the entire 28-day follow-up period of the study.
    • Patients in the study who required an opioid during the 72-hour postoperative period could be identified retrospectively with the following algorithm: pain score ≥6 at 2 hours postoperatively or received opioid rescue medication within the first 2 hours postoperatively.
    • Mean pain intensity scores were similar between cohorts and never rose above the mild pain range (NRS <4) throughout the 72-hour postoperative period.
    • Addition of an intraoperative dose of ketorolac did not provide additional benefit for pain intensity or opioid use.

    HTX-011 was well tolerated, and co-administration with non-steroidal anti-inflammatory drugs did not affect the safety of HTX-011.

    About HTX-011 for Postoperative Pain

    HTX-011, an investigational non-opioid analgesic, is a dual-acting, fixed-dose combination of the local anesthetic bupivacaine with a low dose of the nonsteroidal anti-inflammatory drug meloxicam. It is the first and only extended-release local anesthetic to demonstrate in Phase 3 studies significantly reduced pain and opioid use through 72 hours compared to bupivacaine solution, the current standard-of-care local anesthetic for postoperative pain control. HTX-011 was granted Breakthrough Therapy designation and received Priority Review designation. A complete response letter (CRL) was received from the U.S. Food and Drug Administration (FDA) regarding the New Drug Application (NDA) for HTX-011 in June 2020 relating to non–clinical information. No clinical safety or efficacy issues and no chemistry, manufacturing and controls (CMC) issues were identified. The European Medicines Agency's (EMA) Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion for HTX-011 under the proprietary name ZYNRELEFTM in July 2020. Heron's New Drug Submission (NDS) for HTX-011 for the management of postoperative pain was granted Priority Review status and accepted by Health Canada. Heron is working to respond to a list of questions received from Health Canada in July 2020.

    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. Heron is developing novel, patient-focused solutions that apply its innovative science and technologies to already-approved pharmacological agents for patients suffering from pain or cancer. 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, those associated with: the timing of the NDA resubmission to the FDA; whether the FDA approves the NDA for HTX-011; the timing of the commercial launch of HTX-011 in the U.S.; the timing of the European Commission's (EC) review process for ZYNRELEF; whether the EC authorizes the Marketing Authorisation Application for ZYNRELEF; the timing of the commercial launch of ZYNRELEF in Europe; the timing of Health Canada's NDS review process for HTX-011; whether Health Canada issues a Notice of Compliance for the NDS for HTX-011; the extent of the impact of the ongoing Coronavirus Disease 2019 (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.

    Investor Relations and Media Contact:

    David Szekeres

    Chief Legal, Business and Administrative Officer

     

    858-251-4447

    Cision View original content:http://www.prnewswire.com/news-releases/heron-therapeutics-announces-publication-of-results-from-epoch-2-follow-on-study-a-phase-2b-study-of-htx-011-in-patients-undergoing-hernia-repair-surgery-301131740.html

    SOURCE Heron Therapeutics, Inc.

    View Full Article Hide Full Article
View All Heron Therapeutics Inc. News