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Details:
Ukoniq (umbralisib), is the first and only oral inhibitor of phosphoinositide 3 kinase (PI3K) delta and casein kinase 1 (CK1) epsilon, is indicated for the treatment of adult patients with relapsed or refractory marginal zone lymphoma.
Lead Product(s): Umbralisib
Therapeutic Area: Oncology Product Name: Ukoniq
Highest Development Status: ApprovedProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable June 01, 2022
Details:
The BLA/sNDA submissions of U2 to treat CLL were based on results of UNITY-CLL trial, comparing the combination of TG-1101 (ublituximab) plus UKONIQ (umbralisib), or U2, to an active control arm of obinutuzumab plus chlorambucil in patients with both treatment-naïve CLL.
Lead Product(s): Ublituximab,Umbralisib
Therapeutic Area: Oncology Product Name: TG-1101
Highest Development Status: Phase IIIProduct Type: Large molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable March 03, 2022
Details:
The results showed a possible increased risk of death in patients receiving the combination of Ukoniq and the monoclonal antibody compared to the control arm. And also experienced more serious adverse events than those in the control arm.
Lead Product(s): Umbralisib
Therapeutic Area: Oncology Product Name: Ukoniq
Highest Development Status: ApprovedProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable February 03, 2022
Details:
The UNITY-CLL Phase 3 trial continued enrollment in a 1:1 ratio into the two combination arms: the investigational arm of U2 and the control arm of obinutuzumab plus chlorambucil.
Lead Product(s): Ublituximab,Umbralisib
Therapeutic Area: Oncology Product Name: TG-1101
Highest Development Status: Phase IIIProduct Type: Large molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable November 30, 2021
Details:
The UNITY-CLL Phase 3 trial continued enrollment in a 1:1 ratio into the two combination arms: the investigational arm of U2 and the control arm of obinutuzumab plus chlorambucil.
Lead Product(s): Umbralisib,Ublituximab
Therapeutic Area: Oncology Product Name: TGR-1202
Highest Development Status: Phase II/ Phase IIIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable November 30, 2021
Details:
The Company to review the updated Phase 1 data evaluating the investigational combination of UKONIQ® (umbralisib) and ublituximab (U2) plus venetoclax presented at iwCLL, as well as provide an overview of the ULTRA-V Phase 2/3 trial.
Lead Product(s): Umbralisib,Ublituximab,Venetoclax
Therapeutic Area: Oncology Product Name: TGR-1202
Highest Development Status: Phase II/ Phase IIIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable September 13, 2021
Details:
TG Therapeutics has completed a rolling submission of a BLA to the U.S. FDA requesting approval of ublituximab, in combination with UKONIQTM (umbralisib), as a treatment for patients with CLL, based on the positive results from the UNITY-CLL Phase 3 trial.
Lead Product(s): Ublituximab,Umbralisib
Therapeutic Area: Oncology Product Name: TG-1101
Highest Development Status: Phase IIIProduct Type: Large molecule
Partner/Sponsor/Collaborator: TG Therapeutics
Deal Size: Undisclosed Upfront Cash: Undisclosed
Deal Type: Collaboration April 26, 2021
Details:
Umbralisib (UKONIQ) granted accelerated approval by US FDA for the treatment of adult patients with relapsed or refractory marginal zone lymphoma (MZL), follicular lymphoma (FL).
Lead Product(s): Umbralisib
Therapeutic Area: Oncology Product Name: Ukoniq
Highest Development Status: ApprovedProduct Type: Small molecule
Partner/Sponsor/Collaborator: Rhizen Pharmaceuticals
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable February 08, 2021
Details:
UKONIQ is the first and only, oral, once daily, inhibitor of phosphoinositide 3 kinase delta and casein kinase 1 epsilon. UKONIQ is approved for adult patients with relapsed or refractory marginal zone lymphoma after at least one prior anti-CD20 based regimen.
Lead Product(s): Umbralisib
Therapeutic Area: Oncology Product Name: Ukoniq
Highest Development Status: ApprovedProduct Type: Small molecule
Partner/Sponsor/Collaborator: Rhizen Pharmaceuticals
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable February 05, 2021
Details:
TG Therapeutics has initiated a rolling submission of a Biologics License Application to the U.S. FDA requesting approval of ublituximab, a glycoengineered anti-CD20 monoclonal antibody, in combination with umbralisib, an oral, dual inhibitor of PI3K-delta and CK1-epsilon.
Lead Product(s): Umbralisib,Ublituximab
Therapeutic Area: Oncology Product Name: TGR-1202
Highest Development Status: Phase IIIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable December 01, 2020
Details:
Abstracts highlighting data from two registration directed trials, the UNITY-CLL Phase 3 trial of ublituximab in combination with umbralisib (U2) in CLL, and the UNITY-NHL MZL and FL/SLL umbralisib monotherapy cohorts will be presented at the upcoming ASH conference.
Lead Product(s): Umbralisib,Ublituximab
Therapeutic Area: Oncology Product Name: TGR-1202
Highest Development Status: Phase IIIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable November 02, 2020
Details:
UNITY-CLL is a global Phase 3 randomized controlled trial comparing the combination of ublituximab plus umbralisib, or U2, to an active control arm of obinutuzumab plus chlorambucil in patients with both treatment-naïve and relapsed or refractory chronic lymphocytic leukemia.
Lead Product(s): Umbralisib,Ublituximab
Therapeutic Area: Oncology Product Name: TGR-1202
Highest Development Status: Phase IIIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable October 21, 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).
Lead Product(s): Umbralisib
Therapeutic Area: Oncology Product Name: TGR-1202
Highest Development Status: Phase II/ Phase IIIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable August 13, 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.
Lead Product(s): Umbralisib,Ublituximab
Therapeutic Area: Oncology Product Name: Undisclosed
Highest Development Status: Phase IIIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable July 08, 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.
Lead Product(s): TG-1701,Umbralisib,Ublituximab
Therapeutic Area: Oncology Product Name: TG-1701
Highest Development Status: Phase IProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable June 22, 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).
Lead Product(s): Umbralisib,Ublituximab
Therapeutic Area: Oncology Product Name: TGR-1202
Highest Development Status: Phase IIIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable June 17, 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.
Lead Product(s): TG-1701,Umbralisib,Ublituximab
Therapeutic Area: Oncology Product Name: Undisclosed
Highest Development Status: Phase IProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable June 12, 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.
Lead Product(s): Umbralisib,Ublituximab
Therapeutic Area: Oncology Product Name: Undisclosed
Highest Development Status: Phase IIIProduct 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:
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.
Lead Product(s): Umbralisib,Ublituximab
Therapeutic Area: Oncology Product Name: Undisclosed
Highest Development Status: Phase IIIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable May 05, 2020
Details:
Both the MZL and FL cohorts of the UNITY-NHL trial met their primary endpoints .
Lead Product(s): Umbralisib,Ublituximab,Bendamustine Hydrochloride
Therapeutic Area: Oncology Product Name: Undisclosed
Highest Development Status: Phase II/ Phase IIIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable March 05, 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.
Lead Product(s): Umbralisib,Ublituximab,Bendamustine Hydrochloride
Therapeutic Area: Oncology Product Name: Undisclosed
Highest Development Status: Phase II/ Phase IIIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable January 16, 2020
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