TG Ther­a­peu­tics touts safer PI3Kδ in­hibitor as ex­ecs tout PhII da­ta, hunt quick OK for a tough niche

Eye­ing an ex­pe­dit­ed FDA ap­proval, TG Ther­a­peu­tics un­veiled da­ta from a Phase II PI3Kδ tri­al. They say it shows ef­fec­tive­ness against fol­lic­u­lar lym­phoma with­out the se­vere ad­verse ef­fects that have plagued PI3Kδ treat­ments to date.

TG re­port­ed that it met the goal of hav­ing 40-50% of the 118 fol­lic­u­lar lym­phoma pa­tients treat­ed with um­bral­is­ib re­spond to the drug. The sin­gle-agent study was specif­i­cal­ly de­signed to mod­el the stud­ies that brought ac­cel­er­at­ed FDA ap­proval for oth­er PI3Kδ drugs, TG CEO Michael Weiss said in a con­fer­ence call yes­ter­day.

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