FIERCELY FOCUSED
ON SCIENCE

OUR PIPELINE

MS

ONCOLOGY
REGIMEN DIsease Preclinical Phase 1 Phase 2 Phase 3 Registration Status Learn More

Single
Agent

Ublituximab monotherapy: anti-CD20 mAb Relapsing MS
ULTIMATE I and II
PDUFA 12/28/2022 learnmore

Early Pipeline

Cosibelimab (TG-1501): anti-PD-L1 mAb B-cell malignancies
learnmore
TG-1701: BTK inhibitor B-cell malignancies
learnmore
TG-1801: anti-CD47/CD19 bispecific mAb B-cell malignancies
learnmore
TG-1601: BET inhibitor B-cell malignancies
learnmore
ENROLLMENT COMPLETED
ENROLLMENT ONGOING

Currently all CLL and NHL trials enrolling umbralisib +/- ublituximab are on partial clinical hold.

UKONIQ APPROVAL 2/2021 NOTE: TG Therapeutics has voluntarily withdrawn UKONIQ from sale for the approved indications of adult patients with marginal zone lymphoma (MZL) who have received at least one prior anti-CD20-based regimen and for the treatment of adult patients with follicular lymphoma (FL) who have received at least three prior systemic therapies.

U2 PDUFA 6/25/2022 NOTE: TG has voluntarily withdrawn the pending Biologics License Application (BLA)/supplemental New Drug Application (sNDA) for the combination of ublituximab and UKONIQ® (umbralisib) (combination referred to as U2) for the treatment of adult patients with chronic lymphocytic leukemia (CLL) and small lymphocytic lymphoma (SLL).

The safety and efficacy of our investigational compounds and investigational uses of approved products have not been established. These products and uses have not been approved by the US Food and Drug Administration or other health authorities.

Single Agent

REGIMEN Preclinical Phase 1 Phase 2 Phase 3

MS

Ublituximab monotherapy: anti-CD20 mAb

DiseaseRelapsing MS

Learn More learnmore

ULTIMATE I and II

PDUFA 12/28/2022

EARLY PIPELINE

REGIMEN Preclinical Phase 1 Phase 2 Phase 3
ONCOLOGY
Cosibelimab (TG-1501): anti-PD-L1 mAb

DiseaseB-cell malignancies

Learn More learnmore

TG-1701: BTK inhibitor

DiseaseB-cell malignancies

Learn More learnmore

TG-1801: anti-CD47/CD19 bispecific mAb

DiseaseB-cell malignancies

Learn More learnmore

TG-1601: BET inhibitor

DiseaseB-cell malignancies

Learn More learnmore

ENROLLMENT COMPLETED
ENROLLMENT ONGOING

Currently all CLL and NHL trials enrolling umbralisib +/- ublituximab are on partial clinical hold.

UKONIQ APPROVAL 2/2021 NOTE: TG Therapeutics has voluntarily withdrawn UKONIQ from sale for the approved indications of adult patients with marginal zone lymphoma (MZL) who have received at least one prior anti-CD20-based regimen and for the treatment of adult patients with follicular lymphoma (FL) who have received at least three prior systemic therapies.

U2 PDUFA 6/25/2022 NOTE: TG has voluntarily withdrawn the pending Biologics License Application (BLA)/supplemental New Drug Application (sNDA) for the combination of ublituximab and UKONIQ® (umbralisib) (combination referred to as U2) for the treatment of adult patients with chronic lymphocytic leukemia (CLL) and small lymphocytic lymphoma (SLL).

The safety and efficacy of our investigational compounds and investigational uses of approved products have not been established. These products and uses have not been approved by the US Food and Drug Administration or other health authorities.