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Find Clinical Drug Pipeline Developments & Deals by TG Therapeutics

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            Lead Product(s): Umbralisib

            Therapeutic Area: Oncology Product Name: TGR-1202

            Highest Development Status: Phase II/ Phase III Product Type: Small molecule

            Partner/Sponsor/Collaborator: Not Applicable

            Deal Size: Not Applicable Upfront Cash: Not Applicable

            Deal Type: Not Applicable August 13, 2020

            Details:

            U.S. FDA has accepted the Company’s New Drug Application (NDA) for 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).

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            Lead Product(s): Umbralisib,Ublituximab

            Therapeutic Area: Oncology Product Name: Undisclosed

            Highest Development Status: Phase III Product Type: Small molecule

            Partner/Sponsor/Collaborator: Not Applicable

            Deal Size: Not Applicable Upfront Cash: Not Applicable

            Deal Type: Not Applicable July 08, 2020

            Details:

            The manuscript included preclinical data describing the effects of idelalisib, duvelisib and umbralisib on regulatory T cells (Tregs) on normal human T cells, T cells from CLL patients and T cells in an Eμ-TCL1 adoptive transfer mouse CLL model.

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            Lead Product(s): TG-1701,Umbralisib,Ublituximab

            Therapeutic Area: Oncology Product Name: TG-1701

            Highest Development Status: Phase I Product Type: Small molecule

            Partner/Sponsor/Collaborator: Not Applicable

            Deal Size: Not Applicable Upfront Cash: Not Applicable

            Deal Type: Not Applicable June 22, 2020

            Details:

            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 high selectivity for BTK than, and similar activity to ibrutinib in mantel cell lymphoma models.

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            Lead Product(s): Umbralisib,Ublituximab

            Therapeutic Area: Oncology Product Name: TGR-1202

            Highest Development Status: Phase III Product Type: Small molecule

            Partner/Sponsor/Collaborator: Not Applicable

            Deal Size: Not Applicable Upfront Cash: Not Applicable

            Deal Type: Not Applicable June 17, 2020

            Details:

            TG Therapeutics completed rolling submission of a NDA to the U.S. FDA requesting accelerated approval of umbralisib as a treatment for patients with previously treated marginal zone lymphoma (MZL) and follicular lymphoma (FL).

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            Lead Product(s): TG-1701,Umbralisib,Ublituximab

            Therapeutic Area: Oncology Product Name: Undisclosed

            Highest Development Status: Phase I Product Type: Small molecule

            Partner/Sponsor/Collaborator: Not Applicable

            Deal Size: Not Applicable Upfront Cash: Not Applicable

            Deal Type: Not Applicable June 12, 2020

            Details:

            Company to present data from a Phase 1 study of TG-1701 in combination with umbralisib and ublituximab in relapsed/refractory chronic lymphocytic leukemia and lymphoma, as well as long term data from a Phase 1/1b study evaluating the combination of umbralisib and ibrutinib.

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            Lead Product(s): Ublituximab,Ibrutinib

            Therapeutic Area: Oncology Product Name: Undisclosed

            Highest Development Status: Phase III Product Type: Large molecule

            Partner/Sponsor/Collaborator: Not Applicable

            Deal Size: Not Applicable Upfront Cash: Not Applicable

            Deal Type: Not Applicable May 29, 2020

            Details:

            The addition of ublituximab to ibrutinib significantly improved PFS, ORR, CR rate, and increased rates of uMRD compared with ibrutinib monotherapy.

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            Lead Product(s): Umbralisib,Ublituximab

            Therapeutic Area: Oncology Product Name: Undisclosed

            Highest Development Status: Phase III Product Type: Small molecule

            Partner/Sponsor/Collaborator: J.P. Morgan Securities

            Deal Size: $153.0 million Upfront Cash: Undisclosed

            Deal Type: Public Offering May 14, 2020

            Details:

            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.

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            Lead Product(s): Umbralisib,Ublituximab

            Therapeutic Area: Oncology Product Name: Undisclosed

            Highest Development Status: Phase III Product Type: Small molecule

            Partner/Sponsor/Collaborator: Not Applicable

            Deal Size: Not Applicable Upfront Cash: Not Applicable

            Deal Type: Not Applicable May 05, 2020

            Details:

            UNITY-CLL trial met the primary endpoint of improved progression-free survival (PFS) (p<.0001) and will be stopped early for superior efficacy observed at the interim analysis.

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            Lead Product(s): Umbralisib,Ublituximab,Bendamustine

            Therapeutic Area: Oncology Product Name: Undisclosed

            Highest Development Status: Phase II/ Phase III Product Type: Small molecule

            Partner/Sponsor/Collaborator: Not Applicable

            Deal Size: Not Applicable Upfront Cash: Not Applicable

            Deal Type: Not Applicable March 05, 2020

            Details:

            Both the MZL and FL cohorts of the UNITY-NHL trial met their primary endpoints .

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            Lead Product(s): Umbralisib,Ublituximab,Bendamustine

            Therapeutic Area: Oncology Product Name: Undisclosed

            Highest Development Status: Phase II/ Phase III Product Type: Small molecule

            Partner/Sponsor/Collaborator: Not Applicable

            Deal Size: Not Applicable Upfront Cash: Not Applicable

            Deal Type: Not Applicable January 16, 2020

            Details:

            Drug manufacturer TG Therapeutics, Inc., initiated a rolling application of an NDA for umbralisib seeking rapid FDA approval of the drug for the intended clinical use.