TG Shifts Focus To MS After Pausing Oncology Programs, Ukoniq Withdrawal
Company Looks Ahead To Ublituximab PDUFA Date
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.
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TG, which has seen growing sales for Briumvi in multiple sclerosis, is expanding into CAR-T for immunology as Precision pivots to in vivo gene therapies.
The pricing watchdog said it found “insufficient evidence” to differentiate the benefit of TG’s ublituximab from other antibodies already on the market for multiple sclerosis.
Disappointment for Alembic-backed Rhizen after partner TG Therapeutics takes Ukoniq off the US market amid wider regulatory scrutiny around the PI3K inhibitor class of drugs. The Indian firm, however, remains upbeat about the US business, which saw significant growth in the fiscal fourth quarter and has 15-plus launches lined up.