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TG THERAPEUTICS, INC. (TGTX)

Based in New York City and established in 1993, TG Therapeutics, Inc. is a biopharmaceutical company that has advanced to the commercial stage. Its core mission revolves around the acquisition, advancement, and marketing of novel therapeutic solutions. The company's focus areas specifically include B-cell related cancers (malignancies) and various autoimmune disorders. Among its significant investigational therapeutic candidates is Ublituximab, a distinctive glycoengineered monoclonal antibody currently undergoing evaluation. It targets B-cell non-Hodgkin lymphoma, chronic lymphocytic leukemia (CLL), and the relapsing forms of multiple sclerosis. Another compound in its pipeline is Umbralisib, an orally administered inhibitor designed to block PI3K-delta and CK1-epsilon enzymes. This treatment is being investigated for its effectiveness against CLL, marginal zone lymphoma, and follicular lymphoma. TG Therapeutics is also developing Cosibelimab, an IgG1 human monoclonal antibody that functions by binding to programmed death-ligand 1 (PD-L1) and subsequently preventing its interaction with PD-1 and B7.1 receptors. Furthermore, the company is advancing TG-1701, an oral, covalently-bound Bruton's tyrosine kinase (BTK) inhibitor, notably more selective for BTK compared to ibrutinib in laboratory screenings. Completing this clinical-stage portfolio is TG-1801, a bispecific antibody engineered to simultaneously target CD47 and CD19. Beyond its clinical-stage assets, the company possesses various licensed preclinical programs, including those addressing BET, interleukin-1 receptor associated kinase-4, and GITR. To enhance its research and development capabilities, TG Therapeutics has forged collaboration agreements with entities such as Checkpoint Therapeutics, Inc., Jiangsu Hengrui Medicine Co., Novimmune SA, Ligand Pharmaceuticals Incorporated, and Jubilant Biosys. The company also maintains strategic alliances with partners including LFB Biotechnologies S.A.S, GTC Biotherapeutics, LFB/GTC LLC, Ildong Pharmaceutical Co. Ltd., and Rhizen Pharmaceuticals, S A.

Sector: Pharmaceutical Preparations

Industry: Biotechnology

TG Therapeutics, Inc. logo

TG Therapeutics, Inc.

NASDAQ:TGTXHealthcare
+5.34%$61.18
AH$61.80+1.01%vs close
Mkt Cap$9.36B
Float147.28M
O/S153.07M
Vol
$ Vol
RVOL
Inst Own72.6%
SI20.1%
Earnings
Dilution
TG Therapeutics, Inc. logoNASDAQ:TGTX$61.18+5.34%
Upcoming Catalysts
Phase Distribution
47 lead-sponsored trials·12 active·20 completed
Phase 113
Phase 1/23
Phase 214
Phase 2/33
Phase 38
Not applicable6
(23 more as collaborator)

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

Clinical Trials
Sponsor role
Status
Phase
  • Phase 3
    Completed

    Ublituximab in Combination With Ibrutinib Versus Ibrutinib Alone in Participants With Previously Treated High-Risk Chronic Lymphocytic Leukemia (CLL)

    Ublituximab, Ibrutinib

    Chronic Lymphocytic Leukemia

    Enrollment
    126
    Start
    Jan 2015
    Primary Completion
    Apr 2020
    Completion
    Apr 2020
    NCT02301156
  • Phase 3
    Completed

    Efficacy of Alicaforsen in Pouchitis Patients Who Have Failed to Respond to at Least One Course of Antibiotics

    Alicaforsen, Placebo

    Pouchitis

    Enrollment
    138
    Start
    Dec 2015
    Primary Completion
    Jul 2018
    Completion
    Oct 2018
    NCT02525523
  • Phase 3
    Terminated

    Ublituximab + TGR-1202 Compared to Obinutuzumab + Chlorambucil in Participants With Untreated and Previously Treated Chronic Lymphocytic Leukemia

    Obinutuzumab, Ublituximab

    Chronic Lymphocytic Leukemia

    Enrollment
    603
    Start
    Nov 2015
    Primary Completion
    Feb 2023
    Completion
    Feb 2023
    NCT02612311
  • Phase 3
    Completed

    Study to Assess the Efficacy and Safety of Ublituximab in Participants With Relapsing Forms of Multiple Sclerosis (RMS)

    Ublituximab, Teriflunomide

    Relapsing Multiple Sclerosis (RMS)

    Enrollment
    545
    Start
    Aug 2017
    Primary Completion
    Aug 2020
    Completion
    Nov 2020
    NCT03277248
  • Phase 3
    Completed

    Study to Assess the Efficacy and Safety of Ublituximab in Participants With Relapsing Forms of Multiple Sclerosis (RMS) ( ULTIMATE 1 )

    Ublituximab, Teriflunomide

    Relapsing Multiple Sclerosis (RMS)

    Enrollment
    549
    Start
    Sep 2017
    Primary Completion
    Jul 2020
    Completion
    Nov 2020
    NCT03277261
  • Phase 3
    Active, not recruiting

    An Extension Study of Ublituximab in Participants With Relapsing Multiple Sclerosis

    Ublituximab

    Relapsing Multiple Sclerosis (RMS)

    Enrollment
    1,100
    Start
    Nov 2019
    Primary Completion
    May 2032est.
    Completion
    May 2032est.
    NCT04130997
  • Phase 3
    Recruiting

    Study to Evaluate Safety, Efficacy and Pharmacokinetics (PK) of a Modified Regimen of Ublituximab

    Ublituximab, Placebo

    Relapsing Multiple Sclerosis

    Enrollment
    800
    Start
    Jun 2023
    Primary Completion
    Jan 2027est.
    Completion
    Jan 2027est.
    NCT05877963
  • Phase 3
    Active, not recruiting

    A Study to Evaluate the Pharmacokinetics, Pharmacodynamics, Safety, Radiological and Clinical Effects of Subcutaneous Ublituximab in Participants With Relapsing Multiple Sclerosis (RMS)

    Ublituximab, Ublituximab

    Relapsing Multiple Sclerosis

    Enrollment
    360
    Start
    Jul 2025
    Primary Completion
    Oct 2026est.
    Completion
    Dec 2028est.
    NCT07211633
  • Phase 2/3
    Terminated

    Study to Assess the Efficacy and Safety of Ublituximab + Umbralisib With or Without Bendamustine and Umbralisib Alone in Patients With Previously Treated Non-Hodgkins Lymphoma

    Ublituximab, Umbralisib

    Diffuse Large B-Cell Lymphoma, Follicular Lymphoma +3

    Enrollment
    710
    Start
    May 2016
    Primary Completion
    May 2022
    Completion
    Jul 2022
    NCT02793583
  • Phase 2/3
    Terminated

    Study to Assess the Efficacy and Safety of Ublituximab in Combination With Umbralisib and Venetoclax Compared to Ublituximab in Combination With Umbralisib in Subjects With CLL (ULTRA-V)

    Ublituximab, Umbralisib

    Chronic Lymphocytic Leukemia, Small Lymphocytic Lymphoma

    Enrollment
    277
    Start
    May 2019
    Primary Completion
    Dec 2022
    Completion
    Dec 2022
    NCT03801525
  • Phase 2/3
    Recruiting

    Study to Assess Effects of Ublituximab in Pediatric Participants With Relapsing Forms of Multiple Sclerosis

    Ublituximab, Placebo

    Relapsing Multiple Sclerosis

    Enrollment
    240
    Start
    Jul 2026
    Primary Completion
    Jan 2030est.
    Completion
    Jun 2033est.
    NCT07220252
  • Phase 2
    Unknown status

    Phase 2a Obesity Study of Oral Doses of Oleoyl-Estrone (MP-101)

    oleoyl-estrone (MP 101)

    Obesity

    Enrollment
    100
    Start
    Jun 2006
    Primary Completion
    -
    Completion
    -
    NCT00449202
  • Phase 2
    Unknown status

    Phase 2a Randomized, Double-Blind Study of Oleoyl-Estrone in Male Morbidly Obese Adults

    oleoyl-estrone (MP-101)

    Obesity

    Enrollment
    24
    Start
    Oct 2006
    Primary Completion
    -
    Completion
    -
    NCT00449254
  • Phase 2
    Completed

    A Safety and Efficacy Study of a Topical Gel for the Treatment of Mild to Moderate Psoriasis

    PTH (1-34) Gel / Placebo Gel

    Psoriasis Vulgaris

    Enrollment
    61
    Start
    Oct 2007
    Primary Completion
    Jun 2008
    Completion
    Jul 2008
    NCT00593177
  • Phase 2
    Terminated

    A Study to Evaluate the Safety and Efficacy of Ublituximab in Combination With Umbralisib for Participants Previously Enrolled in Protocol UTX-TGR-304

    Ublituximab, Umbralisib

    Chronic Lymphocytic Leukemia

    Enrollment
    116
    Start
    Jan 2016
    Primary Completion
    May 2022
    Completion
    Jul 2022
    NCT02656303
  • Phase 2
    Completed

    Phase IIa Study of Ublituximab in Participants With Relapsing Forms of Multiple Sclerosis

    Ublituximab, Placebo

    Multiple Sclerosis

    Enrollment
    49
    Start
    May 2016
    Primary Completion
    Sep 2017
    Completion
    Aug 2018
    NCT02738775
  • Phase 2
    Terminated

    Evaluate the Efficacy and Safety of TGR-1202 in Participants With Chronic Lymphocytic Leukemia Who Are Intolerant to Prior Therapy

    Umbralisib

    Chronic Lymphocytic Leukemia

    Enrollment
    51
    Start
    Apr 2016
    Primary Completion
    Jun 2021
    Completion
    Jun 2021
    NCT02742090
  • Phase 2
    Terminated

    Extension Trial of Ublituximab and TGR-1202 in Combination or as Single Agents in Subjects Currently Receiving Treatment on Ublituximab and/or TGR-1202 Trials

    TGR-1202, TGR-1202 + Ublituximab

    Chronic Lymphocytic Leukemia, Non Hodgkin Lymphoma

    Enrollment
    51
    Start
    Aug 2017
    Primary Completion
    May 2022
    Completion
    Jun 2022
    NCT03207256
  • Phase 2
    Completed

    Study to Assess the Efficacy and Safety of Umbralisib in Participants With Non-Follicular Indolent Non-Hodgkin's Lymphoma

    Umbralisib

    Marginal Zone Lymphoma, Waldenstrom Macroglobulinemia +1

    Enrollment
    21
    Start
    Nov 2017
    Primary Completion
    Feb 2022
    Completion
    Feb 2022
    NCT03364231
  • Phase 2
    Completed

    An Extension of the TG1101-RMS201 Trial

    Ublituximab

    Relapsing Remitting Multiple Sclerosis

    Enrollment
    48
    Start
    Jun 2017
    Primary Completion
    Nov 2022
    Completion
    Nov 2022
    NCT03381170
  • Phase 2
    Terminated

    Study to Assess Umbralisib Plus Ublituximab in Participants With Treatment Naïve Follicular Lymphoma

    Ublituximab, Umbralisib

    Follicular Lymphoma, Small Lymphocytic Lymphoma

    Enrollment
    34
    Start
    Jul 2019
    Primary Completion
    May 2022
    Completion
    May 2022
    NCT03828448
  • Phase 2
    Terminated

    Study to Assess the Efficacy and Safety of Ublituximab and Umbralisib in Participants With Chronic Lymphocytic Leukemia (CLL) Currently Treated With Ibrutinib, Acalabrutinib or Venetoclax

    Ublituximab, Umbralisib

    Chronic Lymphocytic Leukemia

    Enrollment
    41
    Start
    Aug 2019
    Primary Completion
    May 2022
    Completion
    May 2022
    NCT04016805
  • Phase 2
    Recruiting

    A Study to Evaluate Pharmacokinetics (PK) and Safety of Subcutaneous (SC) Ublituximab Administered at Various Injection Sites and Relative Bioavailability Via Autoinjector (AI) Versus Syringe Subcutaneously in Participants With Multiple Sclerosis (MS)

    Ublituximab, Ublituximab

    Multiple Sclerosis

    Enrollment
    350
    Start
    Apr 2026
    Primary Completion
    Jul 2027est.
    Completion
    May 2029est.
    NCT07503873
  • Phase 2
    Recruiting

    A Study to Evaluate the Efficacy and Safety of Maintenance Ublituximab Following Induction With Efgartigimod Administration in Participants With Myasthenia Gravis (MG)

    Ublituximab, Placebo

    Myasthenia Gravis

    Enrollment
    120
    Start
    Nov 2026est.
    Primary Completion
    Jul 2028est.
    Completion
    Jan 2030est.
    NCT07673744
  • Phase 2
    Recruiting

    Study to Evaluate the Safety and Efficacy of Ublituximab in Participants With Schizophrenia

    Ublituximab

    Schizophrenia

    Enrollment
    60
    Start
    Jul 2026
    Primary Completion
    Dec 2028est.
    Completion
    Mar 2029est.
    NCT07680946

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