Biotech gets burned at a fire­side chat as CEO re­veals FDA clamped a hold on its can­cer drug, now un­der re­view

A not-so-fun­ny thing hap­pened to TG Ther­a­peu­tics on its way to the ac­com­mo­da­tion re­view for its lead drug. The CEO re­vealed at an in­vest­ment con­fer­ence to­day that the FDA has slapped a hold over a seg­ment of the R&D work it’s do­ing on the drug — a piece of the clin­i­cal plan that spurred some sec­ond looks af­ter the haz­ard ra­tio made the drug look more dan­ger­ous than the com­para­tor.

It was all spelled out in a fresh SEC fil­ing to­day, not­ing that dur­ing a fire­side chat at the B. Ri­ley Se­cu­ri­ties’ 2022 Vir­tu­al On­col­o­gy In­vestor Con­fer­ence, CEO Michael Weiss star­tled in­vestors with the news that the FDA dropped a “par­tial clin­i­cal hold on se­lect stud­ies of U2 and its com­po­nents for chron­ic lym­pho­cyt­ic leukemia and non-Hodgkin’s lym­phoma.” The hold in­volves the U2 ther­a­py, a com­bi­na­tion of an an­ti-CD20 mon­o­clon­al an­ti­body and UKONIQ (um­bral­is­ib), their PI3K-delta and CK1-ep­silon in­hibitor com­pared to the con­trol arm of obin­u­tuzum­ab plus chlo­ram­bu­cil.

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