
TG Therapeutics Inc (NASDAQ:TGTX) shares are trading significantly lower Monday morning after the company announced it has voluntarily withdrawn the pending Biologics License Application/supplemental New Drug Application for the combination of ublituximab and UKONIQ for the treatment of adult patients with chronic lymphocytic leukemia and small lymphocytic lymphoma.
The decision to withdraw the pending applications was based on recently updated overall survival data from the UNITY-CLL Phase 3 trial that showed an increasing imbalance in overall survival.