TG Therapeutics, Inc. (TGTX) Accused of Misleading Investors Regarding Trial Results

The actions concerns TG's UNITY-CLL Trial. The trial is a randomized controlled Phase 3 trial under Special Protocol Assessment that is evaluating TG-1101 in combination with TGR-1202, the company's development stage PI3K delta inhibitor, for patients with front line and previously treated Chronic Lymphocytic Leukemia. Enrollment in the trial began in May 2017, and by September 2017, TG announced its target enrollment had been met. TG also announced that it expected to report top-line overall response rate ("ORR") data from the study in 2018. According to the complaint, TG thereafter touted positive earnings and business outlook for the company, as well as a positive outcome of its UNITY-CLL Trial, "which is expected to support full approval … and a very broad label for the treatment of CLL." Despite these prior assurances, on September 25, 2018, TG announced that it would not be releasing the data from the UNITY-CLL study and that the drugs had failed to meet the ORR stated goal. On this news, the price of TG stock declined from $9.25 per share to $5.15 per share on September 26, 2018, a fall of nearly 45%.

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