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Hold On TG’s Program Stems From Existing – Not New – Concerns

‘Sub-par’ Disclosure Draws Analyst Finger Wagging

 
• By Alaric DeArment

TG expects overall survival hazard ratios to move closer to those of existing CLL drugs. Some analysts called a drop in the company’s shares overblown.

Digital illustration of Cancer cell in colour background
TG disclosed a partial clinical hold on its program to develop Ukoniq/ublituximab in NHL and CLL • Source: Shutterstock

The partial clinical hold on TG Therapeutics, Inc.’s program for PI3K-delta inhibitor Ukoniq (umbralisib) combined with CD20-directed ublituximab – together nicknamed U2 – does not appear to be about any new concerns about Ukoniq. However, it does highlight concerns about the PI3K class overall and the method by which the company disclosed the hold drew criticism.

TG’s CEO Michael Weiss revealed in a fireside chat at B. Riley Securities’ 2022 Virtual Oncology Investor Conference on 27 January that the US Food and Drug Administration had placed...

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