TG won't seek accelerated approval of CLL combo
TG Therapeutics Inc. (NASDAQ:TGTX) shed $4.10 (44%) to $5.15 on Sept. 25 after the company said it will not seek accelerated approval of ublituximab (TG-1101) plus umbralisib (TGR-1202) to treat chronic lymphocytic leukemia. The company said an independent DSMB could not conduct a planned interim analysis of the secondary overall response rate (ORR) endpoint in the Phase III UNITY-CLL trial because data were not sufficiently mature.
Instead, TG plans to seek the combination's full approval based on progression-free survival (PFS), UNITY-CLL's primary endpoint. The company hopes to have PFS data from the trial next year. Chairman, President and CEO Michael Weiss said on a conference call that TG could submit a BLA to FDA for the combo by YE19. The company's cash runway extends through next year...
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