TGTX TG Therapeutics Inc.

20.09
-0.22  -1%
Previous Close 20.31
Open 20.43
52 Week Low 4.95
52 Week High 22.28
Market Cap $2,304,395,163
Shares 114,703,592
Float 87,329,183
Enterprise Value $2,292,256,953
Volume 1,645,855
Av. Daily Volume 2,438,048
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Upcoming Catalysts

Drug Stage Catalyst Date
TG-1101 - ULTIMATE II
Multiple Sclerosis
Phase 3
Phase 3
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TG-1101 - ULTIMATE I
Multiple Sclerosis
Phase 3
Phase 3
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Drug Pipeline

Drug Stage Notes
Umbralisib
Marginal zone lymphoma (MZL) and follicular lymphoma (FL)
NDA Filing
NDA Filing
Rolling NDA has been completed - June 17, 2020.
TG-1101 and TGR-1202 - UNITY-CLL study
Chronic Lymphocytic Leukemia (CLL) and non-Hodgkin's Lymphoma (NHL)
Phase 3
Phase 3
Phase 3 PFS primary endpoint met. Trial to be stopped due to superior efficacy - May 5, 2020.
TG-1101 (ublituximab)
Relapsing forms of Multiple Sclerosis (RMS)
Phase 2
Phase 2
Phase 2 long term follow up data presented at ECTRIMS, September 12, 2019.
TG-1701
Non Hodgkin Lymphoma / Chronic Lymphocytic Leukemia
Phase 1
Phase 1
Phase 1 data presented at ASH December 9, 2019. ORR 86%.
Umbralisib + Ublituximab + Venetoclax
Chronic Lymphocytic Leukemia
Phase 1/2
Phase 1/2
Phase 1/2 data presented at ASH December 8, 2019 noted 100% ORR (9/9) including 44% CR after cycle 12 for the combination.
TGR-1202
Myelofibrosis
Phase 1
Phase 1
Phase 1 updated data released at EHA June 2018. 2 patients (9%) achieved a durable complete remission.
Umbralisib (TGR-1202) + Pembrolizumab + Ublituximab (TG-1101)
Relapsed or refractory Chronic Lymphocytic Leukemia (CLL)
Phase 1/2
Phase 1/2
Phase 1/2 updated data noted 91% ORR for CLL patients; 38% for Richter’s transformation.
TGR-1202 (umbralisib) plus obinutuzumab
Relapsing or refractory Follicular Lymphoma
Phase 2
Phase 2
Phase 2 initiation announced November 27, 2017.
TG-1801
Relapsed or Refractory B-cell Lymphoma
Phase 1
Phase 1
Phase 1 trial initiation announced February 26, 2019.
TG-1101 and IMBRUVICA (GENUINE trial)
Chronic Lymphocytic Leukemia (CLL) cancer
Phase 3
Phase 3
Phase 3 trial met primary endpoint - March 6, 2017. Data presented at ASCO 2017.

Latest News

  1. NEW YORK, June 22, 2020 (GLOBE NEWSWIRE) -- TG Therapeutics, Inc. (NASDAQ:TGTX), today announced preclinical data presentation for TG-1701, the Company's highly selective, BTK inhibitor, at the 2020 American Association for Cancer Research (AACR) annual meeting, being held virtually.

    Michael S. Weiss, the Company's Executive Chairman and Chief Executive Officer stated, "We are encouraged by the preclinical data presented today which showed TG-1701 to be just as active and more selective for BTK than ibrutinib, a currently approved BTK inhibitor. Importantly, we are pleased to see the additive anti-tumor inhibition seen when TG-1701 was combined with umbralisib plus ublituximab (U2), supporting our combinatorial approach to development. The…

    NEW YORK, June 22, 2020 (GLOBE NEWSWIRE) -- TG Therapeutics, Inc. (NASDAQ:TGTX), today announced preclinical data presentation for TG-1701, the Company's highly selective, BTK inhibitor, at the 2020 American Association for Cancer Research (AACR) annual meeting, being held virtually.

    Michael S. Weiss, the Company's Executive Chairman and Chief Executive Officer stated, "We are encouraged by the preclinical data presented today which showed TG-1701 to be just as active and more selective for BTK than ibrutinib, a currently approved BTK inhibitor. Importantly, we are pleased to see the additive anti-tumor inhibition seen when TG-1701 was combined with umbralisib plus ublituximab (U2), supporting our combinatorial approach to development. The proprietary triple combination regimen of U2 + TG-1701 has shown strong responses clinically in an ongoing Phase 1 study, and we look forward to continuing this research and presenting updated data on TG-1701 as a monotherapy and as a triple regimen with U2."

    Highlights from the data presentation are included below.

    Title: TG-1701, a novel irreversible Bruton's kinase (BTK) inhibitor, does not inhibit anti-CD20-driven ADCC and ADCP in vitro, and cooperates with the glycoengineered anti-CD20 mAb, ublituximab, in in vivo mantle cell lymphoma models

    • In vitro and in vivo studies were undertaken to evaluate the activity of TG-1701 alone and in combination with ublituximab and umbralisib in models of lymphoma
    • TG-1701 showed greater selectivity for BTK than, and similar activity to, ibrutinib in mantel cell lymphoma (MCL) models
    • TG-1701, in contrast to ibrutinib, did not block ublituximab-driven antibody-dependent cellular cytotoxicity (ADCC) or antibody-dependent cell phagocytosis (ADCP) in vitro
    • In vivo xenograft studies suggested that TG-1701 synergized with the U2 combination, resulting in greater anti-tumor activity than either TG-1701 or U2 alone



    The above data presentation is available on the Publications page of the Company's website at www.tgtherapeutics.com/publications.cfm.

    ABOUT TG THERAPEUTICS, INC.

    TG Therapeutics is a biopharmaceutical company focused on the acquisition, development and commercialization of novel treatments for B-cell malignancies and autoimmune diseases. Currently, the company is developing multiple therapies targeting hematological malignancies and autoimmune diseases. Ublituximab (TG-1101) is a novel, glycoengineered monoclonal antibody that targets a specific and unique epitope on the CD20 antigen found on mature B-lymphocytes. TG Therapeutics is also developing umbralisib (TGR-1202), an oral, once-daily dual inhibitor of PI3K-delta and CK1-epsilon, which may lead to a differentiated safety profile. Both ublituximab and umbralisib, or the combination of which is referred to as "U2", are in Phase 3 clinical development for patients with hematologic malignancies, with ublituximab also in Phase 3 clinical development for Multiple Sclerosis. Additionally, the Company has recently brought into Phase 1 clinical development its anti-PD-L1 monoclonal antibody, cosibelimab (TG-1501), its covalently-bound Bruton's Tyrosine Kinase (BTK) inhibitor, TG-1701, as well as its anti-CD47/CD19 bispecific antibody, TG-1801. TG Therapeutics is headquartered in New York City.



    Cautionary Statement

    This press release contains forward-looking statements within the meaning of the United States Private Securities Litigation Reform Act of 1995, including statements about the clinical development of our product candidates and our combinatorial approach to development. For these statements, we claim the protection of the safe harbor for forward-looking statements contained in the Private Securities Litigation Reform Act of 1995. These forward-looking statements are subject to risks and uncertainties that may cause our actual results to differ materially.  Factors that could cause such differences include: our ability to successfully and cost-effectively complete preclinical and clinical trials, including clinical trials of TG-1701 and our other pipeline candidates; the risk that the data (both safety and efficacy) from future clinical trials will not coincide with the data analyses from prior preclinical and clinical trials; and other risk factors identified from time to time in our reports filed with the Securities and Exchange Commission.  Any forward-looking statements set forth in this press release speak only as of the date of this press release. We do not undertake to update any of these forward-looking statements to reflect events or circumstances that occur after the date hereof. This press release and prior releases are available at www.tgtherapeutics.com. The information found on our website is not incorporated by reference into this press release and is included for reference purposes only.



    CONTACT:

     Jenna Bosco
     Senior Vice President, 
     Corporate Communications 
     TG Therapeutics, Inc.
     Telephone: 212.554.4351
     Email:

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  2. NEW YORK, June 17, 2020 (GLOBE NEWSWIRE) -- TG Therapeutics, Inc. (NASDAQ:TGTX), a biopharmaceutical company developing medicines for patients with B-cell mediated diseases, today announced the completion of the rolling submission of a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) requesting accelerated approval of umbralisib, the Company's investigational once-daily, oral, dual inhibitor of PI3K-delta and CK1-epsilon, as a treatment for patients with previously treated marginal zone lymphoma (MZL) and follicular lymphoma (FL). The FDA previously granted umbralisib breakthrough therapy designation (BTD) for MZL and orphan drug designation (ODD) for MZL and FL.

    Michael S. Weiss, Executive Chairman and Chief…

    NEW YORK, June 17, 2020 (GLOBE NEWSWIRE) -- TG Therapeutics, Inc. (NASDAQ:TGTX), a biopharmaceutical company developing medicines for patients with B-cell mediated diseases, today announced the completion of the rolling submission of a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) requesting accelerated approval of umbralisib, the Company's investigational once-daily, oral, dual inhibitor of PI3K-delta and CK1-epsilon, as a treatment for patients with previously treated marginal zone lymphoma (MZL) and follicular lymphoma (FL). The FDA previously granted umbralisib breakthrough therapy designation (BTD) for MZL and orphan drug designation (ODD) for MZL and FL.

    Michael S. Weiss, Executive Chairman and Chief Executive Officer of TG Therapeutics stated, "The completion of this NDA submission marks an important milestone in bringing us one step closer to providing umbralisib as a potential treatment option for patients with relapsed/refractory MZL and FL. As a company this is a very exciting moment for us, as it marks our very first NDA submission, and I commend our team for all their efforts to get to this point." Mr. Weiss continued, "Importantly, I also want to thank the patients, their families and the research teams who participated in these trials. This has been an incredibly impactful year for TG thus far, with several important milestones yet to come, including topline data from the ULTIMATE trials of ublitximab in multiple sclerosis, presentation of full data from the UNITY-NHL FL/MZL cohorts and from the UNITY-CLL Phase 3 trial of umbralisib plus ublituximab (U2), and a BLA/NDA submission for U2 in chronic lymphocytic leukemia targeted by the end of the year."

    ABOUT THE UNITY-NHL PHASE 2b STUDY—MZL & FL COHORTS 

    The UNITY- NHL trial is a multicenter, open-label Phase 2b trial.

    The MZL cohort was designed to evaluate the safety and efficacy of single agent umbralisib, in patients with MZL who have received at least one prior anti-CD20 regimen. In February of 2019, the Company announced that the primary endpoint of overall response rate (ORR) as determined by Independent Review Committee (IRC) was met for all treated MZL patients (n=69). The results met the Company's target guidance of 40-50% ORR. Interim safety and efficacy data from the MZL cohort were presented in oral presentations in 2019 at the American Association for Cancer Research (AACR) annual meeting, the American Society of Clinical Oncology (ASCO) annual meeting and the International Conference on Malignant Lymphoma (ICML).

    The FL cohort was designed to evaluate the safety and efficacy of single agent umbralisib in patients with FL who have received at least two prior lines of therapy, including an anti-CD20 regimen and an alkylating agent. In October of 2019, the Company announced that the primary endpoint of ORR as determined by IRC was met for all treated FL patients (n=118). The results met the Company's prespecified response target of 40-50% ORR.



    ABOUT MARGINAL ZONE LYMPHOMA

    Marginal zone lymphoma (MZL) comprises a group of indolent (slow growing) B-cell non-Hodgkin lymphomas (NHLs) that begin forming in the marginal zone of lymphoid tissue. With an annual incidence of approximately 7,500 newly diagnosed patients in the United States1, MZL is the third most common B-cell NHL, accounting for approximately eight percent of all NHL cases. MZL consists of three different subtypes: extranodal MZL of the mucosal-associated lymphoid tissue (MALT), nodal marginal zone lymphoma (NMZL), and splenic marginal zone lymphoma (SMZL)2.



    ABOUT FOLLICULAR LYMPHOMA


    Follicular lymphoma (FL) is typically a slow-growing or indolent form of non-Hodgkin lymphoma (NHL) that arises from B-lymphocytes, making it a B-cell lymphoma. Follicular lymphoma is generally not curable and is a chronic disease. Patients can live for many years with this form of lymphoma. With an annual incidence in the United States of approximately 15,000 newly diagnosed patients3, FL is the most common indolent lymphoma accounting for approximately 20 percent of all NHL cases4.

    ABOUT TG THERAPEUTICS, INC.

    TG Therapeutics is a biopharmaceutical company focused on the acquisition, development and commercialization of novel treatments for B-cell malignancies and autoimmune diseases. Currently, the company is developing two therapies targeting hematological malignancies and autoimmune diseases. Ublituximab (TG-1101) is a novel, glycoengineered monoclonal antibody that targets a specific and unique epitope on the CD20 antigen found on mature B-lymphocytes. TG Therapeutics is also developing umbralisib (TGR-1202), an oral, once-daily dual inhibitor of PI3K-delta and CK1-epsilon, which may overcome certain tolerability issues associated with first generation PI3K-delta inhibitors. Both ublituximab and umbralisib, or the combination of which is referred to as "U2", are in Phase 3 clinical development for patients with hematologic malignancies, with ublituximab also in Phase 3 clinical development for Multiple Sclerosis. Additionally, the Company has recently brought into Phase 1 clinical development its anti-PD-L1 monoclonal antibody, cosibelimab (TG-1501), its covalently-bound Bruton's Tyrosine Kinase (BTK) inhibitor, TG-1701, as well as its anti-CD47/CD19 bispecific antibody, TG-1801. TG Therapeutics is headquartered in New York City.

    2016 Lymphoid Malignancy Statistics by World Health Organization Subtypes VOLUME 66 _ NUMBER 6 _ NOVEMBER/DECEMBER 2016 https://onlinelibrary.wiley.com/doi/pdf/10.3322/caac.21357

    Lymphoma Research Foundation: Marginal Zone Lymphoma

    https://lymphoma.org/aboutlymphoma/nhl/mzl/

    American Cancer Society "Key Statistics for Non-Hodgkin Lymphoma"

    Lymphoma Research Foundation "Follicular Lymphoma"

    Cautionary Statement

    This press release contains forward-looking statements within the meaning of the United States Private Securities Litigation Reform Act of 1995, including statements relating to the NDA submission of umbralisib, the clinical development of our product candidates, and anticipated milestones. For these statements, which are subject to a number of risks and uncertainties, we claim the protection of the safe harbor for forward-looking statements contained in the Private Securities Litigation Reform Act of 1995. In addition to the risk factors identified from time to time in our reports filed with the Securities and Exchange Commission, factors that could cause our actual results to differ materially include the following: the risk that the FDA will not accept the NDA submission of umbralisib in patients with previously treated MZL or FL; the risk that the clinical trial results from the UNITY-NHL MZL or FL cohorts will not be sufficient to support accelerated approval or any regulatory approval of umbralisib for previously treated MZL or FL; the risk that the FDA may delay approval of the umbralisib NDA or grant approval that is more restrictive than anticipated; our ability to commercially launch umbralisib for previously treated MZL or FL, if those indications are approved by the FDA; our ability to successfully and cost-effectively complete our ongoing and planned clinical trials; the risk that early clinical trial results (both safety and efficacy), which may have influenced our decision to proceed with additional clinical trials, will not be reproduced in future studies; the risk that data from the UNITY-CLL Phase 3 trial or the Ultimate I&II trials will not be available in the planned timeframe or not be sufficient to support a regulatory submission; the risk that regulatory submissions will not be completed in the planned timeframe; and our ability to achieve the milestones we project, including the risk that the evolving and unpredictable COVID-19 pandemic delays achievement of those milestones. Any forward-looking statements set forth in this press release speak only as of the date of this press release. We do not undertake to update any of these forward-looking statements to reflect events or circumstances that occur after the date hereof. This press release and prior releases are available at www.tgtherapeutics.com. The information found on our website is not incorporated by reference into this press release and is included for reference purposes only.

    CONTACT:

    Jenna Bosco

    Senior Vice President,

    Corporate Communications

    TG Therapeutics, Inc.

    Telephone: 212.554.4351

    Email:

    Primary Logo

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  3. NEW YORK, June 16, 2020 (GLOBE NEWSWIRE) -- TG Therapeutics, Inc. (NASDAQ:TGTX), today announced that Michael S. Weiss, the Company's Executive Chairman and Chief Executive Officer, will present at the Raymond James 2020 Human Health Innovation Conference, being held virtually. The presentation is scheduled to take place on Thursday, June 18, 2020, at 3:40 PM ET.

    A live webcast of this presentation will be available on the Events page, located within the Investors & Media section, of the Company's website at http://ir.tgtherapeutics.com/events.

    ABOUT TG THERAPEUTICS, INC.
    TG Therapeutics is a biopharmaceutical company focused on the acquisition, development and commercialization of novel treatments for B-cell malignancies and autoimmune diseases…

    NEW YORK, June 16, 2020 (GLOBE NEWSWIRE) -- TG Therapeutics, Inc. (NASDAQ:TGTX), today announced that Michael S. Weiss, the Company's Executive Chairman and Chief Executive Officer, will present at the Raymond James 2020 Human Health Innovation Conference, being held virtually. The presentation is scheduled to take place on Thursday, June 18, 2020, at 3:40 PM ET.

    A live webcast of this presentation will be available on the Events page, located within the Investors & Media section, of the Company's website at http://ir.tgtherapeutics.com/events.

    ABOUT TG THERAPEUTICS, INC.

    TG Therapeutics is a biopharmaceutical company focused on the acquisition, development and commercialization of novel treatments for B-cell malignancies and autoimmune diseases. Currently, the company is developing multiple therapies targeting hematological malignancies and autoimmune diseases. Ublituximab (TG-1101) is a novel, glycoengineered monoclonal antibody that targets a specific and unique epitope on the CD20 antigen found on mature B-lymphocytes. TG Therapeutics is also developing umbralisib (TGR-1202), an oral, once-daily dual inhibitor of PI3K-delta and CK1-epsilon, which may lead to a differentiated safety profile. Both ublituximab and umbralisib, or the combination of which is referred to as "U2", are in Phase 3 clinical development for patients with hematologic malignancies, with ublituximab also in Phase 3 clinical development for Multiple Sclerosis. Additionally, the Company has recently brought into Phase 1 clinical development its anti-PD-L1 monoclonal antibody, cosibelimab (TG-1501), its covalently-bound Bruton's Tyrosine Kinase (BTK) inhibitor, TG-1701, as well as its anti-CD47/CD19 bispecific antibody, TG-1801. TG Therapeutics is headquartered in New York City.

    CONTACT:
     
    Jenna Bosco

    Senior Vice President,

    Corporate Communications

    TG Therapeutics, Inc.

    Telephone: 212.554.4351

    Email:
     

    Primary Logo

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  4. NEW YORK, June 12, 2020 (GLOBE NEWSWIRE) -- TG Therapeutics, Inc. (NASDAQ:TGTX), today announced data presentations at the 25th European Hematology Association (EHA) annual congress including data from a Phase 1 study evaluating TG-1701, the Company's once daily, selective, BTK inhibitor, as monotherapy and in combination with umbralisib and ublituximab (U2) in relapsed/refractory chronic lymphocytic leukemia (CLL) and lymphoma, as well as long term data from a Phase 1/1b study evaluating the combination of umbralisib and ibrutinib in relapsed/refractory CLL and mantle cell lymphoma (MCL).   

    Michael S. Weiss, the Company's Executive Chairman and Chief Executive Officer stated, "We have long been excited about the potential for dual BCR blockade…

    NEW YORK, June 12, 2020 (GLOBE NEWSWIRE) -- TG Therapeutics, Inc. (NASDAQ:TGTX), today announced data presentations at the 25th European Hematology Association (EHA) annual congress including data from a Phase 1 study evaluating TG-1701, the Company's once daily, selective, BTK inhibitor, as monotherapy and in combination with umbralisib and ublituximab (U2) in relapsed/refractory chronic lymphocytic leukemia (CLL) and lymphoma, as well as long term data from a Phase 1/1b study evaluating the combination of umbralisib and ibrutinib in relapsed/refractory CLL and mantle cell lymphoma (MCL).   

    Michael S. Weiss, the Company's Executive Chairman and Chief Executive Officer stated, "We have long been excited about the potential for dual BCR blockade by targeting both PI3K-delta and BTK in the treatment of hematologic malignancies, and these data presentations offer insight into the therapeutic potential for this dual targeted approach. We are extremely pleased to see that TG-1701 continues to exhibit an encouraging safety and efficacy profile, both as a monotherapy and in our proprietary triplet combination with U2, with additional patients now treated and with longer follow-up. We now have patients on TG-1701 for upwards of 1.5 years, with no patients having discontinued therapy due to toxicity and responses deepening over time. We were also excited to see long-term data for the all-oral combination of umbralisib and ibrutinib, which similarly demonstrated continued improvement in overall response rates, and importantly identified no long-term safety signals at over 3.5 years of follow-up, underscoring the potential combinability of umbralisib with BTK therapy."  Mr. Weiss continued, "In striving towards our goal of developing novel combination treatments for patients with unmet medical needs, we are highly encouraged by the data presented today and look forward to continuing dose escalation for our proprietary triple combination of ublituximab, umbralisib and TG-1701."  

    Details of the data presentations are included below.

    Presentation TitleSafety and activity of the once daily selective bruton tyrosine kinase (BTK) inhibitor TG-1701 in patients with chronic lymphocytic leukemia (CLL) and lymphoma



    This presentation includes interim data from a Phase 1 parallel dose-escalation study of TG-1701 monotherapy and TG-1701 in combination with U2 in 82 patients with relapsed/refractory B-cell malignancies. Sixty-nine patients were treated with single agent TG-1701, of which 25 patients were treated in the monotherapy dose escalation portion of the study and received TG-1701 at doses that ranged from 100mg to 400mg once daily, and 44 patients were treated with 200mg of TG-1701 in the monotherapy dose expansion cohort. An additional 13 patients were treated in the TG-1701 plus U2 dose escalation portion of the study.   

    Safety and efficacy highlights include:

    • TG-1701 monotherapy exhibited an encouraging preliminary safety profile across all dose levels evaluated with only 3% (2/69) of patients having a dose reduction due to treatment-related adverse events (AEs), with no treatment discontinuations due to AEs in the monotherapy cohorts
    • In the monotherapy dose escalation cohort (n=25), TG-1701 produced partial responses at all dose levels evaluated (100mg to 400mg once daily) in CLL, MCL, Waldenström's macroglobulinemia (WM), and small lymphocytic lymphoma (SLL)
    • In the monotherapy dose expansion cohort in which TG-1701 was administered at 200mg, 25 patients were evaluable for efficacy with a 92% overall response rate (ORR) observed in CLL patients (n=12), a 33% ORR in MCL patients (n=6), and a 86% ORR in WM patients (n=7)                                                
    • The combination of TG-1701 plus U2 has been well tolerated and demonstrated encouraging clinical activity with a 77% ORR across all disease types (n=13), including complete responses in three patients; dose escalation continues

    Presentation TitleLong term results of a Phase I/Ib study of ibrutinib in combination with umbralisib in patients with relapsed/refractory CLL or MCL



    This presentation includes updated long term data from a Phase 1/1b study of patients with relapsed or refractory CLL or MCL treated with umbralisib in combination with ibrutinib. Data from this trial were previously published in Lancet Haematology in December 2018 (Davids et.al.). As of the updated data cutoff, 42 patients were evaluable for safety and efficacy (21 CLL patients and 21 MCL patients).

    Safety and efficacy highlights include:

    • With long term follow up (median follow-up of 43.5 months (range 8.4-61), there were no cumulative or recurrent late onset toxicities observed
    • In relapsed/refractory CLL, the overall response rate was 95% including a 29% complete response (CR) rate, and the 4-year Progression-free Survival (PFS) and Overall Survival (OS) were 78% and 90%, respectively
    • In relapsed/refractory MCL, the ORR was 71% with a 24% CR rate, and median PFS and OS were 10.8 and 30.7 months, respectively

    The data presented is available on the Publications page, located within the Pipeline section, of the Company's website at www.tgtherapeutics.com/publications.cfm.

    ABOUT TG THERAPEUTICS, INC.

    TG Therapeutics is a biopharmaceutical company focused on the acquisition, development and commercialization of novel treatments for B-cell malignancies and autoimmune diseases. Currently, the company is developing multiple therapies targeting hematological malignancies and autoimmune diseases. Ublituximab (TG-1101) is a novel, glycoengineered monoclonal antibody that targets a specific and unique epitope on the CD20 antigen found on mature B-lymphocytes. TG Therapeutics is also developing umbralisib (TGR-1202), an oral, once-daily dual inhibitor of PI3K-delta and CK1-epsilon, which may lead to a differentiated safety profile. Both ublituximab and umbralisib, or the combination of which is referred to as "U2", are in Phase 3 clinical development for patients with hematologic malignancies, with ublituximab also in Phase 3 clinical development for Multiple Sclerosis. Additionally, the Company has recently brought into Phase 1 clinical development its anti-PD-L1 monoclonal antibody, cosibelimab (TG-1501), its covalently-bound Bruton's Tyrosine Kinase (BTK) inhibitor, TG-1701, as well as its anti-CD47/CD19 bispecific antibody, TG-1801. TG Therapeutics is headquartered in New York City.



    Cautionary Statement

    This press release contains forward-looking statements within the meaning of the United States Private Securities Litigation Reform Act of 1995, including statements relating to the clinical development of our product candidates, our combinatorial approach, and the potential attributes and benefits of our products, either as monotherapy or in combination. For these statements, which are subject to a number of risks and uncertainties, we claim the protection of the safe harbor for forward-looking statements contained in the Private Securities Litigation Reform Act of 1995. Among the factors that could cause our actual results to differ materially are the following: our ability to successfully and cost-effectively complete our ongoing and planned clinical trials; the risk that early clinical trial results (both safety and efficacy), which may have supported the acceptance of our data for presentation or influenced our decision to proceed with additional clinical trials, will not be reproduced in future studies; our ability to achieve the milestones we project, including the risk that the evolving and unpredictable COVID-19 pandemic delays achievement of those milestones; and other risk factors identified from time to time in our reports filed with the Securities and Exchange Commission.  Any forward-looking statements set forth in this press release speak only as of the date of this press release. We do not undertake to update any of these forward-looking statements to reflect events or circumstances that occur after the date hereof. This press release and prior releases are available at www.tgtherapeutics.com. The information found on our website is not incorporated by reference into this press release and is included for reference purposes only.

    CONTACT:



    Jenna A. Bosco

    Senior Vice President,

    Corporate Communications

    TG Therapeutics, Inc.

    Telephone: 212.554.4351

    Email:

    Primary Logo

    View Full Article Hide Full Article
  5. NEW YORK, June 09, 2020 (GLOBE NEWSWIRE) -- TG Therapeutics, Inc. (NASDAQ:TGTX), today announced that Michael S. Weiss, the Company's Executive Chairman and Chief Executive Officer, will participate in a fireside chat during the Gladman Sachs 41st Annual Healthcare Conference, being held virtually. The fireside chat is scheduled to take place on Thursday, June 11, 2020 at 4:40 PM ET.

    A live webcast of this presentation will be available on the Events page, located within the Investors & Media section, of the Company's website at http://ir.tgtherapeutics.com/events.


    ABOUT TG THERAPEUTICS, INC.
    TG Therapeutics is a biopharmaceutical company focused on the acquisition, development and commercialization of novel treatments for B-cell malignancies…

    NEW YORK, June 09, 2020 (GLOBE NEWSWIRE) -- TG Therapeutics, Inc. (NASDAQ:TGTX), today announced that Michael S. Weiss, the Company's Executive Chairman and Chief Executive Officer, will participate in a fireside chat during the Gladman Sachs 41st Annual Healthcare Conference, being held virtually. The fireside chat is scheduled to take place on Thursday, June 11, 2020 at 4:40 PM ET.

    A live webcast of this presentation will be available on the Events page, located within the Investors & Media section, of the Company's website at http://ir.tgtherapeutics.com/events.



    ABOUT TG THERAPEUTICS, INC.

    TG Therapeutics is a biopharmaceutical company focused on the acquisition, development and commercialization of novel treatments for B-cell malignancies and autoimmune diseases. Currently, the company is developing multiple therapies targeting hematological malignancies and autoimmune diseases. Ublituximab (TG-1101) is a novel, glycoengineered monoclonal antibody that targets a specific and unique epitope on the CD20 antigen found on mature B-lymphocytes. TG Therapeutics is also developing umbralisib (TGR-1202), an oral, once-daily dual inhibitor of PI3K-delta and CK1-epsilon, which may lead to a differentiated safety profile. Both ublituximab and umbralisib, or the combination of which is referred to as "U2", are in Phase 3 clinical development for patients with hematologic malignancies, with ublituximab also in Phase 3 clinical development for Multiple Sclerosis. Additionally, the Company has recently brought into Phase 1 clinical development its anti-PD-L1 monoclonal antibody, cosibelimab (TG-1501), its covalently-bound Bruton's Tyrosine Kinase (BTK) inhibitor, TG-1701, as well as its anti-CD47/CD19 bispecific antibody, TG-1801. TG Therapeutics is headquartered in New York City.



    CONTACT:

    Jenna Bosco

    Senior Vice President,

    Corporate Communications

    TG Therapeutics, Inc.

    Telephone: 212.554.4351

    Email:

    Primary Logo

    View Full Article Hide Full Article
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