TG Therapeutics: updated UNITY-CLL OS data improves but FDA imposes partial clinical hold on U2 studies

TG THERAPEUTICS, INC.

Updated OS hazard ratio improved vs preliminary 1.23; still not statistically significant (Sep 2021 cutoff).
FDA placed partial clinical hold on select U2 studies; no new enrollment, existing patients continue after reconsent.
Partial hold based on same data as ODAC meeting scheduled for March/April 2022; no update expected before ODAC.
Company nearing FDA submission of updated OS analysis; interim OS results may change as more events occur.

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