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

by Vandana Singh, Benzinga Editor

May 25, 2021 11:08 AM | 1 min read |

The FDA has accepted for review TG Therapeutics Inc's 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.
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