TG Therapeutics Completes Rolling Submission of New Drug Application to the U.S. Food and Drug Administration for Umbralisib as a Treatment for Patients with Previously Treated Marginal Zone Lymphoma or Follicular Lymphoma

NEW YORK, June 17, 2020 (GLOBE NEWSWIRE) -- TG Therapeutics, Inc. (NASDAQ: TGTX), a biopharmaceutical company developing medicines for patients with B-cell mediated diseases, today announced the completion of the rolling submission of a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) requesting accelerated approval of umbralisib, the Company’s investigational once-daily, oral, dual inhibitor of PI3K-delta and CK1-epsilon, as a treatment for patients with previously treated marginal zone lymphoma (MZL) and follicular lymphoma (FL). The FDA previously granted umbralisib breakthrough therapy designation (BTD) for MZL and orphan drug designation (ODD) for MZL and FL.

Michael S. Weiss, Executive Chairman and Chief Executive Officer of TG Therapeutics stated, "The completion of this NDA submission marks an important milestone in bringing us one step closer to providing umbralisib as a potential treatment option for patients with relapsed/refractory MZL and FL. As a company this is a very exciting moment for us, as it marks our very first NDA submission, and I commend our team for all their efforts to get to this point.” Mr. Weiss continued, “Importantly, I also want to thank the patients, their families and the research teams who participated in these trials. This has been an incredibly impactful year for TG thus far, with several important milestones yet to come, including topline data from the ULTIMATE trials of ublitximab in multiple sclerosis, presentation of full data from the UNITY-NHL FL/MZL cohorts and from the UNITY-CLL Phase 3 trial of umbralisib plus ublituximab (U2), and a BLA/NDA submission for U2 in chronic lymphocytic leukemia targeted by the end of the year.”

ABOUT THE UNITY-NHL PHASE 2b STUDY—MZL & FL COHORTS 
The UNITY- NHL trial is a multicenter, open-label Phase 2b trial.

The MZL cohort was designed to evaluate the safety and efficacy of single agent umbralisib, in patients with MZL who have received at least one prior anti-CD20 regimen. In February of 2019, the Company announced that the primary endpoint of overall response rate (ORR) as determined by Independent Review Committee (IRC) was met for all treated MZL patients (n=69). The results met the Company’s target guidance of 40-50% ORR. Interim safety and efficacy data from the MZL cohort were presented in oral presentations in 2019 at the American Association for Cancer Research (AACR) annual meeting, the American Society of Clinical Oncology (ASCO) annual meeting and the International Conference on Malignant Lymphoma (ICML).