TG Therapeutics Inc's (NASDAQ:TGTX) CEO Michael Weiss said that the FDA has placed a partial clinical hold on some combination candidate studies for leukemia and lymphoma.
- Speaking at the B. Riley Securities' 2022 Virtual Oncology Investor Conference, Weiss disclosed that FDA placed partial holds on studies of the U2 combination UKONIQ (umbralisib) and ublituximab for chronic lymphocytic leukemia (CLL) and non-Hodgkin's lymphoma (NHL).
- Weiss noted that the updated overall survival (OS) preliminary results from the UNITY-CLL study showed improvement. The OS hazard ratio was 1.23, and, including COVID-19 related deaths, the ratio reached 1.04.
- An OS hazard ratio above 1.00 implies the potential risk that the investigational therapy is causing harm.
- Weiss said that no new patients can be enrolled in some CLL and NHL trials, but those seeing a benefit can continue with consent.
- He added that the hold is not based on new information but prior concerns that will be addressed at an Oncologic Drugs Advisory Committee meeting in March or April.
- Price Action: TGTX shares are down 32.9% at $9.33 during the market session on the last check Thursday.
