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HALOZYME THERAPEUTICS, INC. (HALO)

Halozyme Therapeutics, Inc. is a biopharmaceutical company headquartered in San Diego, California, with operations spanning the United States, Switzerland, Ireland, Belgium, Japan, and other international markets. At its core is the proprietary ENHANZE drug delivery platform, which utilizes a patented recombinant human hyaluronidase enzyme (rHuPH20). This innovative technology significantly enhances the subcutaneous (under-the-skin) administration of a diverse range of injectable medicines. This includes complex biologics such as monoclonal antibodies, various other therapeutic molecules, smaller drug compounds, and even fluids. The company's leading product, Hylenex recombinant, is an rHuPH20 formulation specifically designed to facilitate subcutaneous fluid delivery for hydration. It also plays a crucial role in improving the dispersion and absorption of other injected drugs during subcutaneous urography, and aids in the resorption of radiopaque agents. Halozyme also offers several key therapeutics leveraging its platform, including Perjeta, RITUXAN HYCELA, and MabThera SC, which are used to treat non-Hodgkin lymphoma and chronic lymphocytic leukemia (CLL). RITUXAN SC is another offering for CLL patients, while HYQVIA addresses various immunodeficiency disorders. Their development pipeline boasts numerous investigational drugs, such as Tecentriq for non-small cell lung cancer, OCREVUS for multiple sclerosis, and DARZALEX, which targets amyloidosis, smoldering myeloma, and multiple myeloma. Other pipeline candidates include nivolumab for solid tumors, ARGX-113 (a human neonatal Fc receptor), ARGX-117 for autoimmune diseases, and BMS-986179, an anti-CD-73 antibody. Halozyme maintains extensive collaborations with prominent pharmaceutical companies like F. Hoffmann-La Roche, Pfizer Inc., Janssen Biotech, Inc., AbbVie, Inc., Eli Lilly and Company, Bristol-Myers Squibb Company, Alexion Pharma Holding, ARGENX BVBA, and Horizon Therapeutics plc. They also partner with research institutions such as the National Institute of Allergy and Infectious Diseases, the Centre for the AIDS Programme of Research in South Africa, and ViiV Healthcare Limited, particularly focusing on both small and large molecule targets for the treatment and prevention of HIV. The company was established in 1998.

Sector: Biological Products, (No Diagnostic Substances)

Industry: Biotechnology

Halozyme Therapeutics, Inc. logo

Halozyme Therapeutics, Inc.

NASDAQ:HALOHealthcare
-0.21%$130.91
AH$129.48-1.09%vs close
Mkt Cap$14.86B
Float110.43M
O/S113.5M
Vol
$ Vol
RVOL
Inst Own-
SI12.4%
Earnings
Dilution
Halozyme Therapeutics, Inc. logoNASDAQ:HALO$130.91-0.21%
Phase Distribution
33 lead-sponsored trials·1 active·29 completed
Phase 114
Phase 1/22
Phase 27
Phase 33
Phase 47
(15 more as collaborator)
Status Overview
Recruiting1
Completed29
Stopped3

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

Clinical Trials
Sponsor role
Status
Phase
  • Phase 4
    Completed

    A Phase IIIB Dose Comparison Study of Subcutaneous Hydration With and Without Human Recombinant Hyaluronidase (HYLENEX) in Volunteer Subjects

    Hylenex

    Healthy

    Enrollment
    50
    Start
    Nov 2005
    Primary Completion
    -
    Completion
    Jan 2006
    NCT00311519
  • Phase 4
    Completed

    Study of a Large Protein Molecule Administered With Escalating Doses of Recombinant Human Hyaluronidase

    large protein molecule

    Rheumatoid Arthritis

    Enrollment
    15
    Start
    Jul 2006
    Primary Completion
    -
    Completion
    Oct 2006
    NCT00369187
  • Phase 4
    Completed

    Study of Subcutaneous Hydration Enabled by Human Recombinant Hyaluronidase (Hylenex)

    recombinant human hyaluronidase

    Healthy

    Enrollment
    15
    Start
    Dec 2007
    Primary Completion
    Jan 2008
    Completion
    Jan 2008
    NCT00656370
  • Phase 4
    Completed

    Subcutaneous Rehydration Compared to Intravenous Rehydration

    recombinant human hyaluronidase

    Dehydration

    Enrollment
    148
    Start
    Oct 2008
    Primary Completion
    Nov 2009
    Completion
    Dec 2009
    NCT00773175
  • Phase 4
    Completed

    Randomized, Double Blind, 2 Way Crossover Study of CSII With, Versus Without, Pretreatment With Human Hyaluronidase

    Sham Injection, Recombinant human hyaluronidase PH20

    Type 1 Diabetes Mellitus

    Enrollment
    25
    Start
    Dec 2011
    Primary Completion
    Aug 2012
    Completion
    Sep 2013
    NCT01526733
  • Phase 4
    Completed

    CONSISTENT 1: Metabolic and Safety Outcomes of Hylenex Recombinant (Hyaluronidase Human Injection) Preadministered at CSII Infusion Site in Participants With Type 1 Diabetes Mellitus (T1DM)

    Commercial Hylenex® recombinant (hyaluronidase human injection), Precommercial Hylenex recombinant (hyaluronidase human injection)

    Type 1 Diabetes Mellitus

    Enrollment
    456
    Start
    Mar 2013
    Primary Completion
    Feb 2014
    Completion
    Sep 2014
    NCT01848990
  • Phase 4
    Completed

    A Study of Continuous Subcutaneous Insulin Infusion (CSII) Pump Function in Subjects With Type 1 Diabetes With Recombinant Human Hyaluronidase (rHuPH20)

    Rapid Acting insulin with pre-treatment of rHuPH20

    Type 1 Diabetes Mellitus

    Enrollment
    14
    Start
    Oct 2013
    Primary Completion
    Feb 2014
    Completion
    Feb 2014
    NCT03662334
  • Phase 3
    Completed

    INFUSE Morphine Study

    Hylenex

    Pain

    Enrollment
    13
    Start
    Jan 2006
    Primary Completion
    Oct 2006
    Completion
    Oct 2006
    NCT00593281
  • Phase 3
    Terminated

    A Study of PEGylated Recombinant Human Hyaluronidase in Combination With Nab-Paclitaxel Plus Gemcitabine Compared With Placebo Plus Nab-Paclitaxel and Gemcitabine in Participants With Hyaluronan-High Stage IV Previously Untreated Pancreatic Ductal Adenocarcinoma

    Placebo, nab-Paclitaxel

    Pancreatic Ductal Carcinoma

    Enrollment
    492
    Start
    Mar 2016
    Primary Completion
    Nov 2019
    Completion
    Nov 2019
    NCT02715804
  • Phase 3
    Recruiting

    52 Week Study + 24-Month Long-Term Extension of Safety, PK, & Efficacy of XYOSTED® for Testosterone Replacement in Male Adolescents With Hypogonadism

    Testosterone enanthate

    Hypogonadism, Male

    Enrollment
    100
    Start
    Mar 2025
    Primary Completion
    Mar 2028est.
    Completion
    Mar 2030est.
    NCT06689085
  • Phase 2
    Completed

    Phase II Pharmacokinetics Study of Humalog and Humulin-R With and Without rHuPH20 in Type 1 Diabetes Mellitus

    Humalog, Humulin-R

    Type 1 Diabetes Mellitus

    Enrollment
    22
    Start
    Oct 2008
    Primary Completion
    Mar 2009
    Completion
    Mar 2009
    NCT00774800
  • Phase 2
    Completed

    Safety Study of Subcutaneously-Injected Prandial INSULIN-PH20 NP Compared to Insulin Lispro Injection in Participants With Type 1 Diabetes Mellitus

    Insulin Lispro, regular human insulin

    Diabetes Mellitus, Type 1

    Enrollment
    48
    Start
    May 2009
    Primary Completion
    Feb 2010
    Completion
    Apr 2010
    NCT00883558
  • Phase 2
    Completed

    Liquid Meal Study With Insulin Lispro With/Without Recombinant Human Hyaluronidase PH20 (rHuPH20) and Regular Human Insulin With rHuPH20 to Compare Pharmacokinetics, Postprandial Glycemic Response, and Optimal Insulin Dose in Participants With Type 2 Diabetes Mellitus (T2DM)

    Humalog, Humulin-R

    Diabetes Mellitus, Type 2

    Enrollment
    23
    Start
    Jul 2009
    Primary Completion
    Nov 2009
    Completion
    Nov 2009
    NCT00916357
  • Phase 2
    Completed

    Study of the Intradermal Injection of rHuPH20 or Placebo in Participants With Nickel Allergic Contact Dermatitis

    rHuPH20, Placebo

    Dermatitis, Allergic Contact

    Enrollment
    22
    Start
    Jun 2009
    Primary Completion
    Sep 2009
    Completion
    Sep 2009
    NCT00928447
  • Phase 2
    Completed

    Safety/Efficacy Study of Subcutaneously Injected Prandial Insulins Compared to Insulin Lispro Alone in Participants With Type 1 Diabetes Mellitus

    Insulin lispro, recombinant human hyaluronidase PH20

    Diabetes Mellitus, Type 1

    Enrollment
    135
    Start
    Aug 2010
    Primary Completion
    Aug 2011
    Completion
    Aug 2011
    NCT01194245
  • Phase 2
    Completed

    Safety/Efficacy Study of Subcutaneously Injected Prandial Insulins Compared to Insulin Lispro Alone in Patients With Type 2 Diabetes Mellitus

    Insulin lispro, Insulin aspart

    Diabetes Mellitus, Type II

    Enrollment
    132
    Start
    Aug 2010
    Primary Completion
    Aug 2011
    Completion
    Aug 2011
    NCT01194258
  • Phase 2
    Completed

    PEGPH20 Plus Nab-Paclitaxel Plus Gemcitabine Compared With Nab-Paclitaxel Plus Gemcitabine in Participants With Stage IV Untreated Pancreatic Cancer

    PEGPH20, Nab-paclitaxel

    Metastatic Pancreatic Cancer

    Enrollment
    279
    Start
    May 2013
    Primary Completion
    May 2018
    Completion
    Sep 2018
    NCT01839487
  • Phase 1/2
    Completed

    Safety Study of Recombinant Human Hyaluronidase (Chemophase) in Combination With Mitomycin in Participants With Superficial Bladder Cancer

    Mitomycin C, Chemophase

    Bladder Cancer

    Enrollment
    27
    Start
    Mar 2006
    Primary Completion
    Aug 2009
    Completion
    Aug 2009
    NCT00318643
  • Phase 1/2
    Completed

    Study of Gemcitabine + PEGPH20 vs Gemcitabine Alone in Stage IV Previously Untreated Pancreatic Cancer

    Gemcitabine, PEGPH20

    Stage IV Pancreatic Cancer

    Enrollment
    28
    Start
    Sep 2011
    Primary Completion
    Feb 2014
    Completion
    May 2015
    NCT01453153
  • Phase 1
    Completed

    A Study of the Subcutaneous Injection of a Viscous Antibody Solution With Recombinant Human Hyaluronidase

    Hylenex

    Healthy

    Enrollment
    15
    Start
    Feb 2007
    Primary Completion
    -
    Completion
    May 2007
    NCT00435604
  • Phase 1
    Completed

    Pharmacokinetic (PK), Pharmacodynamic (PD), and Safety Study of Subcutaneously Administered Humalog® With and Without Recombinant Human Hyaluronidase (rHuPH20)and Humulin-R® With and Without rHuPH20

    Humalog, Humulin-R

    Diabetes Mellitus

    Enrollment
    26
    Start
    Dec 2007
    Primary Completion
    Feb 2008
    Completion
    Feb 2008
    NCT00705536
  • Phase 1
    Completed

    Study of Immediate Post-Operative Intravesical Instillation of Chemophase® in Patients With Superficial Bladder Cancer

    Chemophase

    Superficial Bladder Cancer

    Enrollment
    14
    Start
    Oct 2008
    Primary Completion
    Mar 2009
    Completion
    Aug 2009
    NCT00782587
  • Phase 1
    Completed

    Dose-Ranging, Pharmacokinetic (PK), Glucodynamic (GD), Safety and Tolerability Study of Subcutaneously (SC) Administered Humulin R and Humalog With or Without rHuPH20

    rHuPH20, Insulin Human Injection

    Healthy Volunteers

    Enrollment
    42
    Start
    Nov 2008
    Primary Completion
    Aug 2009
    Completion
    Aug 2009
    NCT00803972
  • Phase 1
    Completed

    Pharmacokinetic, Safety and Tolerability Study of SC Administered Bisphosphonate With rHuPH20 vs Bisphosphonate Alone

    rHuPH20, zoledronic acid

    Risk Factors for or a Diagnosis of Osteoporosis

    Enrollment
    31
    Start
    Dec 2008
    Primary Completion
    Sep 2009
    Completion
    Sep 2009
    NCT00807963
  • Phase 1
    Completed

    Safety Study of PEGPH20 Given to Patients With Advanced Solid Tumors

    PEGPH20

    Solid Tumor

    Enrollment
    14
    Start
    Feb 2009
    Primary Completion
    Jun 2012
    Completion
    Nov 2012
    NCT00834704

1-25 of 33

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