TG Therapeutics slides on ublituximab study changes
TG Therapeutics Inc. (NASDAQ:TGTX) slid $1.41 (17%) to $6.84 on Thursday after amending the ongoing Phase III GENUINE study of ublituximab ( TG-1101) to treat chronic lymphocytic leukemia (CLL). The company removed the trial's second portion, which was to evaluate progression-free survival (PFS), and trimmed the study's target enrollment.
GENUINE's sole primary endpoint will now compare overall response rate (ORR) for ublituximab plus Imbruvica ibrutinib vs. Imbruvica alone. The company had planned to analyze ORR among roughly the first 200 of a planned 330 total patients in GENUINE, but now intends to cap enrollment at 120 patients and eliminate the planned second portion. The company will no longer conduct the study under an SPA from FDA. ...