TG Therapeutics completes rolling submission of NGA for umbralisib

On Wednesday, TG Therapeutics (Nasdaq: TGTX) announced the completion of the rolling submission of a New Drug Application (NDA) to the US Food and Drug Administration requesting accelerated approval for umbralisib as a treatment for patients with previously-treated marginal zone lymphoma (MZL) and follicular lymphoma (FL), the former a Breakthrough Therapy and Orphan Drug indication and the latter an Orphan Drug-tagged use.

The drug is TG Therapeutic’s investigational once-daily, oral, dual inhibitor of PI3K-delta and CK1-epsilon, as a treatment for patients with previously treated MZL and FL. This is the company’s first NDA submission. 4

Michael Weiss, executive chairman and chief executive 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.”