TG Therapeutics Inc (NASDAQ: TGTX) Withdraws Its sIND and BLA Applications

TG Therapeutics Inc (NASDAQ: TGTX) has withdrawn an sNDA (supplemental new drug application)/ BLA (Biologics License Application) for its UKONIQ-ublituximab combination. The combination, named umbralisib, could potentially treat small lymphocytic lymphoma and chronic lymphocytic leukaemia in adults.

 The company has withdrawn UKONIQ from the market

The company decided to withdraw its application after it got results from its Phase III study that indicated an imbalance in overall survival in the trial patients. Moreover, the company said it had chosen to withdraw UKONIQ from the markets.

TG Therapeutics previously received accelerated approval for the drug in February 2021. TG’s choice to withdraw the drug is linked to its decision to halt the application of a BLA and sIND.

According to TG Therapeutics CEO and Chairman Michael S. Weiss,  the company came to its decision after disappointing results from the Phase III trial. The trial indicated an increasing imbalance in overall survival.

When the company confirmed its results, it decided to withdraw its application. Moreover, the company decided to remove UKONIQ, which treats marginal zone lymphoma in adult patients, from the market. Nevertheless, the company has stated that it is grateful for the part its team and patient volunteers played in trying to develop therapies that treat malignancies of the B-cells.

TG Therapeutics will focus on multiple sclerosis 

Weiss adds that the company had wanted to help patients with chronic lymphocytic leukaemia and small lymphocytic lymphoma. However, this isn’t the end of the road for TG therapeutics, which is still focused on developing treatments for other indications.

For instance, the company has stated that it will continue its work on multiple sclerosis and develop treatment options for autoimmune diseases. Furthermore, the company still has a pending BLA application for ublituximab to treat multiple sclerosis patients who have a relapsing disease.

The company discovered the overall survival after the FDA asked it to provide additional data on the drug. This data differed from the previous one the company had presented to the regulator. Furthermore, the FDA could discuss the drug in a meeting on certain drugs that treat haematological malignancies.

TG Therapeutics is a company that focuses on developing drugs for B-cell malignancies. One of its top projects is to provide treatment to multiple sclerosis patients.