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HERON THERAPEUTICS, INC. /DE/ (HRTX)

Heron Therapeutics, Inc. is a biotechnology firm dedicated to creating innovative therapies for critical patient requirements. The company leverages its proprietary Biochronomer drug delivery platform, an advanced system that enables the controlled release of various short-acting pharmacological agents. This technology ensures therapeutic concentrations are maintained for periods ranging from days to weeks following just a single administration. Among its commercialized products is SUSTOL (granisetron), an extended-release injectable designed to prevent both immediate and delayed nausea and vomiting triggered by moderately emetogenic chemotherapy, or specific anthracycline and cyclophosphamide combination therapies. Additionally, Heron markets CINVANTI, an intravenous formulation of aprepitant. CINVANTI, which acts as a substance P/neurokinin-1 receptor antagonist, is indicated for the prevention of acute and delayed chemotherapy-induced nausea and vomiting in patients undergoing highly or moderately emetogenic cancer chemotherapy. The company's development pipeline includes ZYNRELEF, an innovative dual-acting local anesthetic that combines bupivacaine, a local anesthetic, with a low dose of the nonsteroidal anti-inflammatory drug (NSAID) meloxicam in a single fixed-dose formulation. Also in development is HTX-019, an experimental therapy aimed at preventing postoperative nausea and vomiting (PONV). Furthermore, HTX-034 is being advanced for postoperative pain management and is currently undergoing Phase Ib/II clinical trials, notably in patients recovering from bunionectomy procedures. Originally established in 1983 as A.P. Pharma, Inc., the company adopted its current name, Heron Therapeutics, Inc., in January 2014. Its corporate headquarters are situated in San Diego, California.

Sector: Pharmaceutical Preparations

Industry: Biotechnology

Heron Therapeutics, Inc. logo

Heron Therapeutics, Inc.

NASDAQ:HRTXHealthcare
-5.67%$0.2777
AH$0.2849+2.59%vs close
Mkt Cap$52.73M
Float149.18M
O/S189.87M
Vol
$ Vol
RVOL
Inst Own69.4%
Earnings
Dilution
Phase Distribution
26 lead-sponsored trials·2 active·22 completed
Phase 1/21
Phase 212
Phase 36
Phase 46
Not applicable1
(3 more as collaborator)
Status Overview
Active, not recruiting2
Completed22
Stopped2

Trials need funding. See this company's dilution risk and cash position.

Clinical Trials
Sponsor role
Status
Phase
  • Phase 4
    Completed

    Bupivacaine HCl PK and Safety in Augmentation Mammoplasty

    Bupivacaine HCl

    Postoperative Pain

    Enrollment
    30
    Start
    Sep 2018
    Primary Completion
    Oct 2018
    Completion
    Nov 2018
    NCT03705065
  • Phase 4
    Completed

    Extended Delivery of Bupivacaine Study in Herniorrhaphy

    Bupivacaine liposome injectable suspension, Bupivacaine HCl without epinephrine via continuous infusion

    Analgesia

    Enrollment
    32
    Start
    Jul 2018
    Primary Completion
    Sep 2018
    Completion
    Oct 2018
    NCT04102267
  • Phase 4
    Active, not recruiting

    A Multi-surgery Assessment of ZYNRELEF (HTX-011), AMAZE. Master Protocol HTX-011-401.

    Bupivacaine Hydrochloride, Bupivacaine Hydrochloride

    Analgesia

    Enrollment
    90
    Start
    Oct 2021
    Primary Completion
    Jun 2024est.
    Completion
    Jun 2024est.
    NCT05109312
  • Phase 4
    Active, not recruiting

    Safety Study of Repeat Doses of SUSTOL in Adults

    SUSTOL

    Chemotherapy-Induced Nausea and Vomiting (CINV)

    Enrollment
    300
    Start
    Jul 2022
    Primary Completion
    Oct 2025est.
    Completion
    Oct 2025est.
    NCT05434663
  • Phase 4
    Completed

    Cohort 1 (TSA) of: A Multi-surgery Assessment of ZYNRELEF (HTX-011)

    HTX-011, Bupivacaine Hydrochloride

    Postoperative Pain, Total Shoulder Arthroplasty +1

    Enrollment
    30
    Start
    Oct 2021
    Primary Completion
    Jul 2022
    Completion
    Jul 2022
    NCT06109415
  • Phase 4
    Completed

    Cohort 2 (Abdominoplasty) of: A Multi-surgery Assessment of ZYNRELEF (HTX-011)

    MMA regimen, HTX-011

    Postoperative Pain, Abdominoplasty Surgery +1

    Enrollment
    37
    Start
    Oct 2021
    Primary Completion
    Mar 2022
    Completion
    Apr 2022
    NCT06109428
  • Phase 3
    Completed

    APF530 or Aloxi (Palonosetron Hydrochloride) Combined With Dexamethasone in Preventing Nausea and Vomiting in Patients Receiving Chemotherapy for Cancer

    APF530, dexamethasone

    Nausea and Vomiting, Unspecified Adult Solid Tumor, Protocol Specific

    Enrollment
    1,428
    Start
    Jun 2006
    Primary Completion
    Sep 2008
    Completion
    Feb 2009
    NCT00343460
  • Phase 3
    Completed

    A Prospective, Multicenter, Study of APF530 (Granisetron) SC for Prevention of CINV in Patients Receiving HEC

    APF530, Ondansetron

    Chemotherapy-induced Nausea and Vomiting

    Enrollment
    942
    Start
    Mar 2014
    Primary Completion
    May 2015
    Completion
    May 2015
    NCT02106494
  • Phase 3
    Completed

    Phase 3 Herniorrhaphy Study for Postoperative Analgesia (EPOCH 2)

    HTX-011, Bupivacaine HCl

    Postoperative Pain

    Enrollment
    418
    Start
    Jul 2017
    Primary Completion
    Dec 2017
    Completion
    Jan 2018
    NCT03237481
  • Phase 3
    Completed

    Bunionectomy Study for Postoperative Analgesia (EPOCH 1)

    HTX-011, Saline Placebo

    Postoperative Pain

    Enrollment
    412
    Start
    Oct 2017
    Primary Completion
    Jan 2018
    Completion
    Mar 2018
    NCT03295721
  • Phase 3
    Completed

    Study of Post-Herniorrhaphy Non-opioid MMA Regimens

    HTX-011, Ibuprofen

    Analgesia

    Enrollment
    209
    Start
    Apr 2019
    Primary Completion
    Oct 2021
    Completion
    Nov 2021
    NCT03907176
  • Phase 3
    Completed

    Total Knee Arthroplasty (TKA) Study of HTX-011 in an Multimodal Analgesic Regimen (MMA) Regimen

    HTX-011, Ibuprofen

    Analgesia

    Enrollment
    116
    Start
    Jun 2019
    Primary Completion
    Dec 2020
    Completion
    Jan 2021
    NCT03974932
  • Phase 2
    Completed

    HTX-011 for Post-bunionectomy Analgesia

    HTX-011, Placebo

    Analgesia

    Enrollment
    71
    Start
    Jun 2015
    Primary Completion
    Sep 2015
    Completion
    Sep 2015
    NCT02471898
  • Phase 2
    Completed

    Pilot Herniorrhaphy Study for Postoperative Analgesia

    HTX-011, Placebo

    Postoperative Pain

    Enrollment
    463
    Start
    Jul 2015
    Primary Completion
    Mar 2017
    Completion
    Apr 2017
    NCT02504580
  • Phase 2
    Completed

    Evaluation of the Efficacy and Safety of HTX-011 for Postoperative Analgesia Following Abdominoplasty Surgery

    HTX-011B, Placebo

    Postoperative Pain

    Enrollment
    277
    Start
    Feb 2016
    Primary Completion
    Mar 2017
    Completion
    Apr 2017
    NCT02689258
  • Phase 2
    Completed

    Evaluation of the Efficacy and Safety of Locally Administered HTX-011 for Postoperative Analgesia Following Bunionectomy

    HTX-011A, Saline Placebo

    Postoperative Pain, Bunions

    Enrollment
    430
    Start
    May 2016
    Primary Completion
    Feb 2017
    Completion
    Mar 2017
    NCT02762929
  • Phase 2
    Completed

    Phase 2B Upper Extremity Nerve Block Study

    HTX-011, Bupivacaine HCl without epinephrine

    Postoperative Pain

    Enrollment
    243
    Start
    Jan 2017
    Primary Completion
    Feb 2018
    Completion
    Mar 2018
    NCT03011333
  • Phase 2
    Completed

    Total Knee Arthroplasty Infiltration Study for Postoperative Analgesia

    HTX-011, Saline Placebo

    Postoperative Pain

    Enrollment
    285
    Start
    Jan 2017
    Primary Completion
    Apr 2018
    Completion
    May 2018
    NCT03015532
  • Phase 2
    Completed

    Phase 2 Herniorrhaphy Study for Opioid Elimination

    HTX-011, Ibuprofen

    Postoperative Pain

    Enrollment
    63
    Start
    Oct 2018
    Primary Completion
    Nov 2018
    Completion
    Dec 2018
    NCT03695367
  • Phase 2
    Completed

    Phase 2 Bunionectomy HTX-011 Administration Study

    HTX-011, aprepitant

    Postoperative Pain

    Enrollment
    78
    Start
    Oct 2018
    Primary Completion
    Jan 2019
    Completion
    Mar 2019
    NCT03718039
  • Phase 2
    Withdrawn

    Pediatric Postoperative Analgesia Herniorrhaphy Study

    HTX-011, Bupivacaine HCl

    Analgesia

    Enrollment
    0
    Start
    Jul 2023est.
    Primary Completion
    Nov 2025est.
    Completion
    Dec 2025est.
    NCT03922048
  • Phase 2
    Completed

    PK and Safety After C-Section

    HTX-011, MMA regimen

    Postoperative Pain

    Enrollment
    25
    Start
    Jun 2019
    Primary Completion
    Dec 2021
    Completion
    Dec 2021
    NCT03955211
  • Phase 2
    Terminated

    Aprepitant Injectable Emulsion in Patients With COVID-19 (GUARDS-1)

    Aprepitant injectable emulsion, Saline Placebo

    COVID-19

    Enrollment
    27
    Start
    Jul 2020
    Primary Completion
    Apr 2021
    Completion
    Jun 2021
    NCT04470622
  • Phase 2
    Completed

    HTX-011 in Spinal Surgery

    Bupivacaine HCI without epinephrine, HTX-011

    Post-Operative Pain, Lumbar Laminectomy

    Enrollment
    32
    Start
    Apr 2022
    Primary Completion
    Jul 2022
    Completion
    Aug 2022
    NCT04911062
  • Phase 1/2
    Completed

    Dose-Escalation Study of HTX-034 Following Bunionectomy

    HTX-034 low dose, HTX-034 high dose

    Bunions, Postoperative Pain

    Enrollment
    78
    Start
    May 2020
    Primary Completion
    Jul 2021
    Completion
    Jul 2021
    NCT04398329

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