TG Therapeutics, Inc. announced that the United States Food and Drug Administration has cleared its Investigational New Drug Application for TGR-1202, the company's novel, highly specific PI3K-Delta inhibitor being developed jointly with Rhizen Pharmaceuticals Sa. TGR-1202 is a highly specific, orally available, PI3K delta inhibitor, targeting the delta isoform with nanomolar potency and several fold selectivity over the alpha, beta, and gamma isoforms of PI3K. Inhibition of PI3K delta signaling with TGR-1202 has demonstrated robust activity in numerous pre-clinical models and primary cells from patients with hematologic malignancies.

TG Therapeutics, Inc. and Rhizen Pharmaceuticals, SA are jointly developing TGR-1202 on a worldwide basis, excluding India.