UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
WASHINGTON, D.C. 20549
FORM
CURRENT REPORT
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Item 8.01. Other Events.
On April 15, 2022, TG Therapeutics, Inc. (the “Company”) issued a press release announcing the Company had voluntarily withdrawn the pending Biologics License Application (BLA)/supplemental New Drug Application (sNDA) for the combination of ublituximab and UKONIQ® (umbralisib)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 on recently updated overall survival (OS) data from the UNITY-CLL Phase 3 trial that showed an increasing imbalance in OS in favor of the control arm (obinutuzumab in combination with chlorambucil).
In addition, the Company announced that it voluntarily withdrew UKONIQ from sale for the approved indications of adult patients with marginal zone lymphoma (MZL) who have received at least one prior anti-CD20-based regimen and for the treatment of adult patients with follicular lymphoma (FL) who have received at least three prior systemic therapies. UKONIQ was granted accelerated approval in these indications in February 2021. The Company’s decision to withdraw UKONIQ from sale was primarily based on the withdrawal of the BLA and sNDA for U2 in CLL.
The Company will host a conference call today, Monday, April 18, 2022 at 8:30 a.m. to discuss the regulatory updates. A copy of the press release is being filed as Exhibit 99.1 and incorporated in this Item by reference.
Item 9.01 Financial Statements And Exhibits.
(d) | Exhibits. |
99.1 | |
Exhibit 104 | The cover page from this Current Report on Form 8-K formatted in Inline XBRL. |
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SIGNATURES
Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.
TG Therapeutics, Inc. | ||
(Registrant) | ||
Date: April 18, 2022 | By: | /s/ Sean A. Power |
Sean A. Power | ||
Chief Financial Officer | ||
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