Benzinga | May 25, 2021 11:08AM EDT

TG Therapeutics' Ublituximab-Umbralisib Combo Application Under FDA Review for Hematological Malignancies

* The FDA has accepted for review TG Therapeutics Inc's (NASDAQ: TGTX) marketing application seeking approval for ublituximab in combination with Ukoniq (umbralisib) for chronic lymphocytic leukemia (CLL) and small lymphocytic lymphoma (SLL).

* The agency's action date is March 25, 2022.

* The FDA also notified the company that it is not currently planning to hold an advisory committee meeting to discuss this application.

* Ublituximab is the company's investigational glycoengineered anti-CD20 monoclonal antibody.

* Umbralisib is a once-daily, oral inhibitor of PI3K-delta and CK1-epsilon.

* Price Action: TGTX shares are down 1.22% at $33.31 on the last check Tuesday.

* Related content: Benzinga's Full FDA Calendar