TG Ther­a­peu­tics shares rock­et up on suc­cess­ful PhI­II leukemia study, tee­ing up a shot at ac­cel­er­at­ed FDA OK

Shares of TG Ther­a­peu­tics $TGTX rock­et­ed up 64% this morn­ing af­ter the New York-based biotech re­port­ed that its lead can­cer drug scored a win in Phase III. And now the biotech plans to pur­sue an ac­cel­er­at­ed ap­proval at the FDA.

In­ves­ti­ga­tors say that TG-1101 (ubli­tux­imab), their an­ti-CD20 mon­o­clon­al an­ti­body, plus Im­bru­vi­ca beat Im­bru­vi­ca alone in treat­ing high-risk chron­ic lym­pho­cyt­ic leukemia, or CLL. The com­bi­na­tion arm scored an over­all re­sponse rate of 80% com­pared to on­ly 47% in the so­lo drug arm. A to­tal of 126 pa­tients were re­cruit­ed for the Phase III.

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