TGTX TG Therapeutics Inc.

50.18
-0.01  -0%
Previous Close 50.19
Open 51.01
52 Week Low 6.34
52 Week High 56.74
Market Cap $6,915,315,585
Shares 137,810,195
Float 110,435,786
Enterprise Value $6,703,623,687
Volume 912,854
Av. Daily Volume 2,198,479
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Upcoming Catalysts

Drug Stage Catalyst Date
Umbralisib
Marginal zone lymphoma (MZL)
PDUFA priority review
PDUFA priority review
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Umbralisib (UNITY-NHL)
Follicular lymphoma (FL)
PDUFA
PDUFA
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TG-1101 and TGR-1202 - UNITY-CLL study
Chronic Lymphocytic Leukemia (CLL) and non-Hodgkin's Lymphoma (NHL)
BLA Filing
BLA Filing
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Drug Pipeline

Drug Stage Notes
TG-1101 - ULTIMATE I
Multiple Sclerosis
Phase 3
Phase 3
Phase 3 trial met primary endpoint - December 10. 2020.
TG-1101 - ULTIMATE II
Multiple Sclerosis
Phase 3
Phase 3
Phase 3 trial met primary endpoint - December 10. 2020.
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.
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.
Repotrectinib (TPX-0005) - TRIDENT-2
KRAS mutant NSCLC
Phase 2
Phase 2
Phase 2 trial to be initiated mid-2021.
TG-1701
Non Hodgkin Lymphoma / Chronic Lymphocytic Leukemia
Phase 1
Phase 1
Phase 1 data presented at ASH December 9, 2019. ORR 86%.
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.
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, Jan. 15, 2021 (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 B. Riley Securities Oncology Investor Conference being held virtually. The fireside chat is scheduled to take place on Wednesday, January 20, 2021 at 10:00 AM 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. A replay of the webcast will be available on TG's website following the event.

    ABOUT TG THERAPEUTICS, INC.
    TG Therapeutics is a biopharmaceutical company focused on the acquisition…

    NEW YORK, Jan. 15, 2021 (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 B. Riley Securities Oncology Investor Conference being held virtually. The fireside chat is scheduled to take place on Wednesday, January 20, 2021 at 10:00 AM 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. A replay of the webcast will be available on TG's website following the event.

    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. Umbralisib is currently under review by the U.S. Food and Drug Administration (FDA) for accelerated approval as a treatment for patients with previously treated marginal zone lymphoma (MZL) who have received at least one prior anti-CD20 based regimen or follicular lymphoma (FL) who have received at least two prior systemic therapies. 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 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:



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  2. NEW YORK, Jan. 08, 2021 (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 39th Annual J.P. Morgan Healthcare Conference, being held virtually. The presentation is scheduled to take place on Tuesday, January 12, 2021 at 2:00 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. A replay of the webcast will be available on TG's website following the event.

    ABOUT TG THERAPEUTICS, INC.
    TG Therapeutics is a biopharmaceutical company focused on the acquisition, development and commercialization…

    NEW YORK, Jan. 08, 2021 (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 39th Annual J.P. Morgan Healthcare Conference, being held virtually. The presentation is scheduled to take place on Tuesday, January 12, 2021 at 2:00 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. A replay of the webcast will be available on TG's website following the event.

    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. Umbralisib is currently under review by the U.S. Food and Drug Administration (FDA) for accelerated approval as a treatment for patients with previously treated marginal zone lymphoma (MZL) who have received at least one prior anti-CD20 based regimen or follicular lymphoma (FL) who have received at least two prior systemic therapies. 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 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 A. Bosco

                      Senior Vice President,

                      Corporate Communications

                      TG Therapeutics, Inc.

                      Telephone: 212.554.4351

                      Email:



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  3. NEW YORK, Dec. 14, 2020 (GLOBE NEWSWIRE) -- TG Therapeutics, Inc. (NASDAQ:TGTX), a biopharmaceutical company developing medicines for patients with B-cell mediated diseases ("the Company"), today announced the pricing of an underwritten public offering of 6,320,000 shares of common stock at a public offering price of $43.50 per share. Gross proceeds to the Company from the offering are expected to be approximately $275,000,000 before deducting underwriting discounts and commissions and estimated offering expenses payable by the Company. In addition, the Company has granted the underwriters a 30-day option to purchase up to an additional 948,000 shares of common stock in connection with the offering. All shares are being sold by the Company…

    NEW YORK, Dec. 14, 2020 (GLOBE NEWSWIRE) -- TG Therapeutics, Inc. (NASDAQ:TGTX), a biopharmaceutical company developing medicines for patients with B-cell mediated diseases ("the Company"), today announced the pricing of an underwritten public offering of 6,320,000 shares of common stock at a public offering price of $43.50 per share. Gross proceeds to the Company from the offering are expected to be approximately $275,000,000 before deducting underwriting discounts and commissions and estimated offering expenses payable by the Company. In addition, the Company has granted the underwriters a 30-day option to purchase up to an additional 948,000 shares of common stock in connection with the offering. All shares are being sold by the Company. The offering is expected to close on December 17, 2020, subject to the satisfaction of customary closing conditions. The offering was upsized from the previously announced offering size of approximately $200,000,000 of common stock.

    The Company anticipates using net proceeds from the offering to fund the continued development of ublituximab and umbralisib, the potential in-license, acquisition, development and commercialization of other pharmaceutical products, and for general corporate purposes.

    J.P. Morgan Securities LLC, Goldman Sachs & Co. LLC, Evercore Group L.L.C., and Cantor Fitzgerald & Co. are acting as joint book-running managers for the proposed offering. B. Riley Securities, Inc., H.C. Wainwright & Co., LLC, and Ladenburg Thalmann & Co. Inc. are acting as co-managers for the offering.

    The shares of common stock described above are being offered by the Company pursuant to its automatically effective shelf registration statement previously filed with the SEC on September 5, 2019. A preliminary prospectus supplement and accompanying prospectus relating to and describing the terms of the offering has been filed with the SEC and is available on the SEC's web site at www.sec.gov. Copies of the final prospectus supplement and accompanying prospectus, when available, may also be obtained from J.P. Morgan Securities LLC, Attention: Broadridge Financial Solutions, 1155 Long Island Avenue, Edgewood, NY 11717 or by telephone at (866) 803-9204, or email: ; Goldman Sachs & Co. LLC, Prospectus Department, 200 West Street, New York, NY 10282, telephone: 1-866-471-2526, facsimile: 212-902-9316 or by emailing ; Evercore Group L.L.C, Attention: Equity Capital Markets, 55 East 52nd Street, 37th Floor, New York, NY 10055, by telephone at (888) 474-0200, or email: ; and Cantor Fitzgerald & Co., Attention: Capital Markets, 499 Park Ave., 6th Floor, New York, New York 10022, by email: .  

    This press release shall not constitute an offer to sell or the solicitation of an offer to buy, nor shall there be any sale of, these securities in any state or jurisdiction in which such offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of any such state or jurisdiction.

    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. Umbralisib is currently under review by the U.S. Food and Drug Administration (FDA) for accelerated approval as a treatment for patients with previously treated marginal zone lymphoma (MZL) who have received at least one prior anti-CD20 based regimen or follicular lymphoma (FL) who have received at least two prior systemic therapies. 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 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.



    Forward-Looking Statements

    Some of the statements included in this press release may be forward-looking statements that involve a number of risks and uncertainties. For those statements, 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: statements regarding the proposed public offering and the intended use of proceeds from the proposed offering; the success and timing of our clinical trials and preclinical studies for our product candidates, including site initiation, internal review board approval, scientific review committee approval, patient accrual, safety, tolerability and efficacy data observed, and input from regulatory authorities; our plans to develop and commercialize our product candidates; market acceptance of our products; reimbursement available for our products; our available cash and investments; our ability to obtain and maintain intellectual property protection for our product candidates; our ability to manufacture; the performance of third-party manufacturers, clinical research organizations, clinical trial sponsors and clinical trial investigators; 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.

    CONTACT:

    Jenna Bosco

    Senior Vice President

    Corporate Communications

    TG Therapeutics, Inc.

    Telephone: 212.554.4351

    Email:

     



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  4. NEW YORK, Dec. 14, 2020 (GLOBE NEWSWIRE) -- TG Therapeutics, Inc. (NASDAQ:TGTX), a biopharmaceutical company dedicated to developing medicines for patients with B-cell mediated diseases ("TG Therapeutics"), today announced that it has commenced an underwritten public offering of $200,000,000 of its common stock. The offering is subject to market and other conditions, and there can be no assurance as to whether or when the offering may be completed, or as to the actual size or terms of the offering. TG Therapeutics intends to grant the underwriters a 30-day option to purchase up to an additional $30,000,000 of its common stock.

    TG Therapeutics intends to use the net proceeds of the public offering to fund the continued development of ublituximab…

    NEW YORK, Dec. 14, 2020 (GLOBE NEWSWIRE) -- TG Therapeutics, Inc. (NASDAQ:TGTX), a biopharmaceutical company dedicated to developing medicines for patients with B-cell mediated diseases ("TG Therapeutics"), today announced that it has commenced an underwritten public offering of $200,000,000 of its common stock. The offering is subject to market and other conditions, and there can be no assurance as to whether or when the offering may be completed, or as to the actual size or terms of the offering. TG Therapeutics intends to grant the underwriters a 30-day option to purchase up to an additional $30,000,000 of its common stock.

    TG Therapeutics intends to use the net proceeds of the public offering to fund the continued development of ublituximab and umbralisib, the potential in-license, acquisition, development and commercialization of other pharmaceutical products, and for general corporate purposes.

    J.P. Morgan Securities LLC, Goldman Sachs & Co. LLC, Evercore Group L.L.C., and Cantor Fitzgerald & Co. are acting as joint book-running managers for the proposed offering.

    The public offering of common stock is being made pursuant to an automatically effective shelf registration statement previously filed with the SEC on September 5, 2019. The offering will be made only by means of a written prospectus and prospectus supplement that form a part of the registration statement. A preliminary prospectus supplement and the accompanying prospectus related to the offering will be filed with the SEC and available on the website of the SEC at www.sec.gov. Copies of the preliminary prospectus supplement and accompanying prospectus, when available, may also be obtained from J.P. Morgan Securities LLC, Attention: Broadridge Financial Solutions, 1155 Long Island Avenue, Edgewood, NY 11717 or by telephone at (866) 803-9204, or email: ; Goldman Sachs & Co. LLC, Prospectus Department, 200 West Street, New York, NY 10282, telephone: 1-866-471-2526, facsimile: 212-902-9316 or by emailing ; Evercore Group L.L.C, Attention: Equity Capital Markets, 55 East 52nd Street, 37th Floor, New York, NY 10055, by telephone at (888) 474-0200, or email: ; and Cantor Fitzgerald & Co., Attention: Capital Markets, 499 Park Ave., 6th Floor, New York, New York 10022, by email: .

    This press release shall not constitute an offer to sell or the solicitation of an offer to buy, nor shall there be any sale of, these securities in any state or jurisdiction in which such offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of any such state or jurisdiction.

    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. Umbralisib is currently under review by the U.S. Food and Drug Administration (FDA) for accelerated approval as a treatment for patients with previously treated marginal zone lymphoma (MZL) who have received at least one prior anti-CD20 based regimen or follicular lymphoma (FL) who have received at least two prior systemic therapies. 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 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.



    Forward-Looking Statements

    Some of the statements included in this press release may be forward-looking statements that involve a number of risks and uncertainties. For those statements, 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: statements regarding the proposed public offering and the intended use of proceeds from the proposed offering; the success and timing of our clinical trials and preclinical studies for our product candidates, including site initiation, internal review board approval, scientific review committee approval, patient accrual, safety, tolerability and efficacy data observed, and input from regulatory authorities; our plans to develop and commercialize our product candidates; market acceptance of our products; reimbursement available for our products; our available cash and investments; our ability to obtain and maintain intellectual property protection for our product candidates; our ability to manufacture; the performance of third-party manufacturers, clinical research organizations, clinical trial sponsors and clinical trial investigators; 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.

    CONTACT:
     
    Jenna Bosco

    Senior Vice President

    Corporate Communications

    TG Therapeutics, Inc.

    Telephone: 212.554.4351

    Email:


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  5. Both studies met their primary endpoint of significantly reducing annualized relapse rate (ARR) study) with ublituximabeach of the studies

    Relative reductions of approximately 60% and 50% in ARR over teriflunomide were observed in ULTIMATE I & II, respectively

    Detailed data presentation targeted in 1H 2021 with a BLA submission targeted mid-year 2021

    Conference call to be held today, Thursday, December 10, 2020 at 8:30 AM ET

    NEW YORK, Dec. 10, 2020 (GLOBE NEWSWIRE) -- TG Therapeutics, Inc. (NASDAQ:TGTX), today announced positive topline results from two global, active-controlled, Phase 3 studies, called ULTIMATE I & II, evaluating ublituximab, the Company's investigational novel…

    Both studies met their primary endpoint of significantly reducing annualized relapse rate (ARR) (p<0.005 in each study) with ublituximab demonstrating an ARR of <0.10 in each of the studies

    Relative reductions of approximately 60% and 50% in ARR over teriflunomide were observed in ULTIMATE I & II, respectively

    Detailed data presentation targeted in 1H 2021 with a BLA submission targeted mid-year 2021

    Conference call to be held today, Thursday, December 10, 2020 at 8:30 AM ET

    NEW YORK, Dec. 10, 2020 (GLOBE NEWSWIRE) -- TG Therapeutics, Inc. (NASDAQ:TGTX), today announced positive topline results from two global, active-controlled, Phase 3 studies, called ULTIMATE I & II, evaluating ublituximab, the Company's investigational novel, glycoengineered anti-CD20 monoclonal antibody, compared to teriflunomide in patients with relapsing forms of multiple sclerosis (RMS). Both studies met their primary endpoint with ublituximab treatment demonstrating a statistically significant reduction in annualized relapse rate (ARR) over a 96-week period (p<0.005 in each trial). Ublituximab treatment resulted in an ARR of <0.10 in each of ULTIMATE I & II, with a relative reduction in ARR of approximately 60% and 50%, respectively, over teriflunomide.

    The ULTIMATE I & II studies investigated the safety and efficacy of a one-hour 450mg infusion of ublituximab every six months, following the Day 1 infusion (150mg over four hours). The studies were conducted under Special Protocol Assessment (SPA) agreement with the U.S. Food and Drug Administration (FDA). Further analyses of the ULTIMATE I & II studies including safety and secondary endpoints will be conducted and detailed data will be presented at an upcoming medical congress, targeted in first half of 2021. Additionally, data from these studies are intended to support a Biologics License Application (BLA) submission for ublituximab in RMS targeted in mid-year 2021.



    Lawrence Steinman, MD, Zimmermann Professor of Neurology & Neurological Sciences, and Pediatrics at Stanford University and Global Study Chair for the ULTIMATE I & II studies commented, "B-cell targeted therapy with anti-CD20 monoclonal antibodies has dramatically shifted the treatment paradigm for patients with MS and has shown to be very effective in reducing relapses in patients. I am pleased to see such positive results from this important trial exploring a one-hour infusion of ublituximab every six months and believe, if approved, the unique attributes of ublituximab, particularly that it has been glycoengineered for enhanced antibody dependent cellular cytotoxicity, may offer benefits to patients in the RMS treatment paradigm." Dr. Steinman continued, "MS is a chronic demyelinating disease where having a variety of treatment options within the same class has shown to be important for patients. I look forward to the full data from the ULTIMATE studies to further understand the potential of ublituximab in MS."



    Michael S. Weiss, Executive Chairman and Chief Executive Officer of TG Therapeutics stated, "We are so pleased to share these positive topline results for our ULTIMATE MS studies. If approved, ublituximab has the potential to offer patients a one-hour infusion, which we believe will be an attractive option for many patients with MS. With more than 1,000,000 Americans estimated to be living with MS today, there continues to be a need for efficacious and convenient treatment options." Mr. Weiss continued, "We want to thank the patients, caregivers, doctors and research teams who participated in these studies, as well as the TG team for their efforts in helping to achieve this important milestone. We look forward to a detailed presentation of the data at a major medical meeting in the first half of 2021 once the full data are analyzed, as well as completing a BLA submission targeted for mid-next year."



    ABOUT THE ULTIMATE I & II TRIALS

    ULTIMATE I and ULTIMATE II are two independent Phase 3, randomized, double-blinded, active-controlled, global, multi-center studies evaluating the efficacy and safety/tolerability of ublituximab (450mg dose administered by one-hour intravenous infusion every 6 months, following a Day 1 infusion of 150mg over four hours and a Day 15 infusion of 450mg over one hour) versus teriflunomide (14mg oral tablets taken once daily) in subjects with relapsing forms of Multiple Sclerosis (RMS). The primary endpoint for each study was Annualized Relapse Rate (ARR) following 96 weeks of treatment. Secondary endpoints include total number of T1 gadolinium-enhancing lesions, total number of new and/or enlarging T2 hyperintense lesions, and time to confirmed disability progression (CDP). The ULTIMATE I & II trials enrolled a total of 1,094 patients with RMS across 10 countries. These trials were led by Lawrence Steinman, MD, Zimmermann Professor of Neurology & Neurological Sciences, and Pediatrics at Stanford University and were conducted under a Special Protocol Assessment (SPA) agreement with the U.S. Food and Drug Administration (FDA). Additional information on these clinical trials can be found at www.clinicaltrials.gov (NCT03277261; NCT03277248).

    CONFERENCE CALL INFORMATION

    The Company will host a conference call today, Thursday December 10, 2020 at 8:30 AM ET to discuss the ULTIMATE I & II Topline Results. In order to participate in the conference call, please call 1-877-407-8029 (U.S.), 1-201-689-8029 (outside the U.S.), Conference Title: TG Therapeutics. 

    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 www.tgtherapeutics.com. An audio recording of the conference call will also be available for replay at www.tgtherapeutics.com, for a period of 30 days after the call.



    ABOUT MULTIPLE SCLEROSIS

    Relapsing multiple sclerosis (RMS) is a chronic demyelinating disease of the central nervous system (CNS) and includes people with relapsing-remitting multiple sclerosis (RRMS) and people with secondary progressive multiple sclerosis (SPMS) who continue to experience relapses. RRMS is the most common form of multiple sclerosis (MS) and is characterized by episodes of new or worsening signs or symptoms (relapses) followed by periods of recovery. It is estimated that nearly 1 million people are living with MS in the United States and approximately 85% are initially diagnosed with RRMS.1,2 The majority of people who are diagnosed with RRMS will eventually transition to SPMS, in which they experience steadily worsening disability over time. Worldwide, more than 2.3 million people have a diagnosis of MS.1



    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. Umbralisib is currently under review by the U.S. Food and Drug Administration (FDA) for accelerated approval as a treatment for patients with previously treated marginal zone lymphoma (MZL) who have received at least one prior anti-CD20 based regimen or follicular lymphoma (FL) who have received at least two prior systemic therapies. 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 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 that involve a number of risks and uncertainties. For those 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 include, but may not be limited to, statements anticipating the benefits of ublituximab and projecting publication and regulatory submission timelines. Factors that could cause our actual results to differ materially include the following:  our ability to successfully deliver the complete data set from the ULTIMATE I & II trials and complete a BLA submission on schedule as planned; the risk that safety issues or trends will be observed in the ULTIMATE I & II trials when the full safety dataset is available and analyzed; the risk that secondary endpoints from the ULTIMATE I & II will not be positive; the risk that the clinical results from the ULTIMATE I & II trials will not support regulatory approval of ublituximab to treat RMS or, if approved, that ublituximab will not be commercially successful; other uncertainties inherent in research and development; 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. Further discussion about these and other risks and uncertainties can be found in our Annual Report on Form 10-K for the fiscal year ended December 31, 2019 and in our other filings with the U.S. 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:

    1. MS Prevalence. National Multiple Sclerosis Society website. https://www.nationalmssociety.org/About-the-Society/MS-Prevalence. Accessed October 26, 2020. 2. Multiple Sclerosis International Federation, 2013 via Datamonitor p. 236.



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