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UKONIQ APPROVAL 2/2021 NOTE: TG Therapeutics has voluntarily withdrawn UKONIQ from sale for the approved indications of adult patients with marginal zone lymphoma (MZL) who have received at least one prior anti-CD20-based regimen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U2 PDUFA 6/25/2022 NOTE: TG has voluntarily withdrawn the pending Biologics License Application (BLA)/supplemental New Drug Application (sNDA) for the combination of ublituximab and UKONIQ® (umbralisib)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.