TG Therapeutics withdraws BLA/sNDA for U2 in CLL/SLL; pulls UKONIQ from sale

TG THERAPEUTICS, INC.

Voluntarily withdrew BLA/sNDA for U2 (ublituximab + umbralisib) for CLL/SLL based on updated OS data imbalance favoring control arm.
Withdrew UKONIQ (umbralisib) from sale for accelerated-approved MZL and FL indications; FDA expected to withdraw approval.
UNITY-CLL Phase 3 met primary PFS endpoint but updated OS showed increasing imbalance; ODAC meeting canceled.
Company to focus on ublituximab BLA for relapsing MS (PDUFA Sept 28, 2022); conference call April 18 at 8:30 AM ET.

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