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Inc (NASDAQ:TGTX) shares are trading significantly lower Monday morning after the company announced it has voluntarily withdrawn the pending Biologics License Application/supplemental New Drug Application for the combination of ublituximab and UKONIQ for the treatment of adult patients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.
In addition, TG Therapeutics announced it has voluntarily withdrawn UKONIQ from sale for the approved indications of adult patients. The withdrawal decision was primarily based on the withdrawal of the aforementioned BLA and sNDA.
TG Therapeutics is a biopharmaceutical company focused on the acquisition, development and commercialization of novel treatments for B-cell diseases.
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TGTX 52-Week Range: $7.73 - $49.38
According to data from Benzinga Pro, the stock was down 36.7% at $5.60 at time of publication.
Photo: jarmoluk from Pixabay.
