TG Ther­a­peu­tics gets 3-month punt from FDA for stand­alone BLA in af­ter­math of Ukoniq + ad­comm with­draw­al

Just over a month af­ter B-cell ma­lig­nan­cy and au­toim­mune-fo­cused biotech TG Ther­a­peu­tics with­drew its ap­pli­ca­tion for blood can­cer com­bo U2 one week be­fore an ad­comm, the FDA wants more time to re­view da­ta on one of its com­po­nents, pend­ing ap­proval as a stand­alone treat­ment.

The biotech an­nounced ear­ly Tues­day that the FDA ex­tend­ed the PDU­FA date to Dec. 28 for ubli­tux­imab, one of the com­po­nents in TG’s pre­vi­ous blood can­cer com­bo known as U2. The biotech had sub­mit­ted a BLA for the drug can­di­date as a treat­ment for RMS, or re­laps­ing forms of mul­ti­ple scle­ro­sis.

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