Two years af­ter U2 dis­ap­point­ment, TG Ther­a­peu­tics wins back in­vestors with PFS win — set­ting the stage for NDA

Sep­tem­ber 2018 was sup­posed to hold a cru­cial mo­ment for TG Ther­a­peu­tics. It was the month that re­searchers were due to an­a­lyze the over­all re­sponse rate to its com­bo of ubli­tux­imab plus um­bral­is­ib in the Phase III UNI­TY-CLL.

In­stead, the da­ta safe­ty mon­i­tor­ing board de­cid­ed the da­ta were not yet ma­ture enough, and the New York biotech aban­doned its orig­i­nal goal to score ac­cel­er­at­ed ap­proval with ORR, wait for the pri­ma­ry end­point of pro­gres­sion-free sur­vival and file for a full OK. Per­haps pre­dict­ing the sub­se­quent stock plunge, CEO Michael Weiss plead­ed with “long-term share­hold­ers” to stick around for that new plan.

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