TG Therapeutics (TGTX) Voluntarily Withdraws BLA/sNDA for U2 to Treat Patients with CLL and SLL

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TG Therapeutics Announces Voluntary Withdrawal of the BLA/sNDA for U2 to Treat Patients with CLL and SLL

April 15, 2022 8:30 AM EDT

Company voluntarily withdraws UKONIQ® from sale for approved indications of relapsed/refractory MZL and FL Company to host conference call, Monday, April 18, 2022 at 8:30 AM ET NEW YORK, April 15, 2022 (GLOBE NEWSWIRE) -- TG Therapeutics, Inc. (NASDAQ: TGTX), today announced that the Company has voluntarily withdrawn the pending Biologics License Application (BLA)/supplemental New Drug Application (sNDA) for the combination of ublituximab and UKONIQ® (umbralisib) (combination referred to as U2) for the treatment of adult patients with chronic lymphocytic leukemia (CLL) and small lymphocytic lymphoma (SLL). The decision to withdraw was based... More