Future Of TG’s Ukoniq In Question As Drug Attracts Closer FDA Scrutiny
The agency has suspended enrollment in Ukoniq trials while also hinting at greater scrutiny of “the continued marketing” of the drug.
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TG Therapeutics is withdrawing the PI3K-delta inhibitor from the market and halting enrolling in other umbralisib oncology studies to focus attention on ublituximab in relapsing multiple sclerosis.
MEI/Kyowa Kirin will no longer seek accelerated approval based on a single-arm study as the FDA is calling for Phase III data due to growing conservatism regarding the PI3K class.
Even as magrolimab stumbled, the company remains optimistic about the rest of its pipeline, from potential pipeline-in-a-pill Trodelvy to an oral COVID-19 drug.