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#000000;margin:0pt;"><span style="font-size:1pt;visibility:hidden;">&#8203;</span></p><a id="_eb2ddbce_4c88_4698_9ea9_b298b5867e58"></a><p style="font-family:'Times New Roman','Times','serif';font-size:10pt;text-align:center;text-indent:0pt;margin:0pt;"><span style="font-size:6pt;font-weight:bold;margin-bottom:12pt;visibility:hidden;">&#8203;</span></p><p style="font-family:'Times New Roman','Times','serif';font-size:10pt;text-align:center;text-indent:0pt;margin:0pt;"><b style="font-weight:bold;">UNITED STATES</b></p><p style="font-family:'Times New Roman','Times','serif';font-size:10pt;text-align:center;text-indent:0pt;margin:0pt;"><b style="font-weight:bold;">SECURITIES AND EXCHANGE COMMISSION</b></p><p style="font-family:'Times New Roman','Times','serif';font-size:10pt;text-align:center;text-indent:0pt;margin:0pt 0pt 8pt 0pt;"><b style="font-weight:bold;">WASHINGTON, D.C. 20549</b></p><div style="font-family:'Times New 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Pre-commencement communications pursuant to Rule&#160;13e-4(c)&#160;under the Exchange Act.</span></p><p style="font-family:'Times New Roman','Times','serif';font-size:10pt;text-indent:0pt;margin:0pt 0pt 10pt 0pt;"><span style="font-size:9pt;">Indicate by check mark whether the registrant is an emerging growth company as defined in Rule&#160;405 of the Securities Act of 1933 (17 CFR &#167;230.405) or Rule&#160;12b-2 of the Securities Exchange Act of 1934 (17 CFR &#167;240.12b-2). 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<div style="background-color:#000000;clear:both;height:2pt;page-break-after:always;width:79.3%;border:0;margin:30pt 10.35% 30pt 10.35%;"></div><div style="max-width:100%;padding-left:10.35%;padding-right:10.35%;position:relative;"><div style="clear:both;max-width:100%;position:relative;"><a id="_a2c76d1f_e33e_4eda_b654_4cbc60b8f130"></a><p style="font-family:'Times New Roman','Times','serif';font-size:9pt;font-weight:bold;margin:0pt 0pt 12pt 0pt;">Item&#160;<b style="font-weight:bold;white-space:pre-wrap;">8.01.  Other Events.</b></p><p style="font-family:'Times New Roman','Times','serif';font-size:9pt;text-indent:36pt;margin:0pt 0pt 12pt 0pt;">On April 15, 2022, TG Therapeutics, Inc. (the &#8220;Company&#8221;) issued a press release announcing the Company had voluntarily withdrawn the pending Biologics License Application (BLA)/supplemental New Drug Application (sNDA) for the combination of ublituximab and UKONIQ&#174; (umbralisib)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).</p><p style="font-family:'Times New Roman','Times','serif';font-size:9pt;text-indent:36pt;margin:0pt 0pt 12pt 0pt;">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&#8217;s decision to withdraw UKONIQ from sale was primarily based on the withdrawal of the BLA and sNDA for U2 in CLL.</p><p style="font-family:'Times New Roman','Times','serif';font-size:9pt;text-indent:36pt;margin:0pt 0pt 12pt 0pt;"><span style="white-space:pre-wrap;">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.</span></p><a id="_152d5988_4373_4464_831a_aabe06c13fa0"></a><p style="font-family:'Times New Roman','Times','serif';font-size:9pt;font-weight:bold;margin:0pt 0pt 12pt 0pt;">Item&#160;<b style="font-weight:bold;white-space:pre-wrap;">9.01  Financial Statements And Exhibits.</b></p><table style="border-collapse:collapse;border:0;"><tr><td style="vertical-align:text-top;white-space:nowrap;width:18pt;padding:0pt;"><p style="font-family:'Times New Roman','Times','serif';font-size:10pt;margin-bottom:0pt;margin-top:0pt;"><span style="font-size:9pt;">(d)</span></p></td><td style="padding:0pt;"><p style="font-family:'Times New Roman','Times','serif';font-size:10pt;margin-bottom:0pt;margin-top:0pt;"><span style="font-size:9pt;">Exhibits.</span></p></td></tr></table><p style="font-family:'Times New Roman','Times','serif';font-size:10pt;margin:0pt;"><span style="font-size:9pt;visibility:hidden;">&#8203;</span></p><table style="border-collapse:collapse;font-size:16pt;height:max-content;padding-left:0pt;padding-right:0pt;width:99.02%;"><tr style="height:1pt;"><td style="vertical-align:bottom;width:14.03%;margin:0pt;padding:0pt;"><div style="height:1pt;overflow:hidden;overflow-wrap:break-word;position:relative;"><div style="bottom:0pt;position:absolute;width:100%;"></div></div></td><td style="vertical-align:bottom;width:85.96%;margin:0pt;padding:0pt;"><div style="height:1pt;overflow:hidden;overflow-wrap:break-word;position:relative;"><div style="bottom:0pt;position:absolute;width:100%;"></div></div></td></tr><tr><td style="vertical-align:bottom;width:14.03%;margin:0pt;padding:0pt;"><p style="font-family:'Times New Roman','Times','serif';font-size:9pt;margin:0pt;">99.1</p></td><td style="vertical-align:bottom;width:85.96%;margin:0pt;padding:0pt;"><p style="font-family:'Times New Roman','Times','serif';font-size:10pt;margin:0pt;"><a style="-sec-extract:exhibit;font-family:&quot;'Times New Roman','Times','serif'&quot;;font-size:9pt;" href="tgtx-20220415xex99d1.htm"><span style="font-family:'Times New Roman','Times','serif';font-style:normal;font-weight:normal;">Press Release, dated April 15, 2022.</span></a></p></td></tr><tr><td style="vertical-align:bottom;width:14.03%;margin:0pt;padding:0pt;"><p style="font-family:'Times New Roman','Times','serif';font-size:10pt;margin:0pt;"><span style="font-size:9pt;visibility:hidden;">&#8203;</span></p></td><td style="vertical-align:bottom;width:85.96%;margin:0pt;padding:0pt;"><p style="font-family:'Times New Roman','Times','serif';font-size:10pt;margin:0pt;"><span style="font-size:9pt;visibility:hidden;">&#8203;</span></p></td></tr><tr><td style="vertical-align:bottom;width:14.03%;margin:0pt;padding:0pt;"><p style="font-family:'Times New Roman','Times','serif';font-size:9pt;margin:0pt;">Exhibit 104</p></td><td style="vertical-align:bottom;width:85.96%;margin:0pt;padding:0pt;"><p style="font-family:'Times New Roman','Times','serif';font-size:9pt;margin:0pt;">The cover page from this Current Report on Form 8-K formatted in Inline XBRL. </p></td></tr></table><p style="font-family:'Times New Roman','Times','serif';font-size:10pt;text-indent:0pt;margin:0pt;"><span style="font-size:1pt;margin-bottom:12pt;visibility:hidden;">&#8203;</span></p><p style="font-family:'Times New Roman','Times','serif';font-size:10pt;text-indent:0pt;margin:0pt;"><span style="margin-bottom:12pt;visibility:hidden;">&#8203;</span></p><p style="font-family:'Times New Roman','Times','serif';font-size:10pt;margin:0pt;"><span style="visibility:hidden;">&#8203;</span></p><p style="font-family:'Times New Roman','Times','serif';font-size:10pt;margin:0pt;"><span style="visibility:hidden;">&#8203;</span></p></div><div style="clear:both;margin-bottom:30pt;width:100%;"><p style="font-family:'Times New Roman','Times','serif';font-size:10pt;text-align:center;margin:24pt 0pt 0pt 0pt;">- 2 -</p></div></div>
<div style="background-color:#000000;clear:both;height:2pt;page-break-after:always;width:79.3%;border:0;margin:30pt 10.35% 30pt 10.35%;"></div><div style="max-width:100%;padding-left:10.35%;padding-right:10.35%;position:relative;"><div style="clear:both;max-width:100%;position:relative;"><a id="_b229c785_8e5a_41cf_8575_5e663d43d82d"></a><p style="font-family:'Times New Roman','Times','serif';font-size:10pt;font-weight:bold;text-align:center;margin:0pt 0pt 12pt 0pt;">SIGNATURES</p><p style="font-family:'Times New Roman','Times','serif';font-size:10pt;text-indent:36pt;margin:0pt 0pt 12pt 0pt;">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.</p><table style="border-collapse:collapse;font-size:16pt;height:max-content;padding-left:0pt;padding-right:0pt;width:100%;"><tr style="height:1pt;"><td style="vertical-align:bottom;width:49.74%;margin:0pt;padding:0pt;"><div style="height:1pt;overflow:hidden;overflow-wrap:break-word;position:relative;"><div style="bottom:0pt;position:absolute;width:100%;"><p style="font-family:'Times New Roman','Times','serif';font-size:10pt;margin:0pt;"><span style="font-size:1pt;visibility:hidden;">&#8203;</span></p></div></div></td><td style="vertical-align:bottom;width:4.03%;margin:0pt;padding:0pt;"><div style="height:1pt;overflow:hidden;overflow-wrap:break-word;position:relative;"><div style="bottom:0pt;position:absolute;width:100%;"><p style="font-family:'Times New Roman','Times','serif';font-size:10pt;margin:0pt;"><span style="font-size:1pt;visibility:hidden;">&#8203;</span></p></div></div></td><td style="vertical-align:bottom;width:46.21%;margin:0pt;padding:0pt;"><div style="height:1pt;overflow:hidden;overflow-wrap:break-word;position:relative;"><div style="bottom:0pt;position:absolute;width:100%;"><p style="font-family:'Times New Roman','Times','serif';font-size:10pt;margin:0pt;"><span style="font-size:1pt;visibility:hidden;">&#8203;</span></p></div></div></td></tr><tr><td style="vertical-align:bottom;width:49.74%;margin:0pt;padding:0pt;"><p style="font-family:'Times New Roman','Times','serif';font-size:10pt;margin:0pt;"><span style="visibility:hidden;">&#8203;</span></p></td><td colspan="2" style="vertical-align:bottom;width:50.25%;margin:0pt;padding:0pt;"><p style="font-family:'Times New Roman','Times','serif';font-size:10pt;margin:0pt;"><b style="font-weight:bold;">TG Therapeutics, Inc.</b></p></td></tr><tr><td style="vertical-align:bottom;width:49.74%;margin:0pt;padding:0pt;"><p style="font-family:'Times New Roman','Times','serif';font-size:10pt;margin:0pt;"><span style="visibility:hidden;">&#8203;</span></p></td><td colspan="2" style="vertical-align:bottom;width:50.25%;margin:0pt;padding:0pt;"><p style="font-family:'Times New Roman','Times','serif';font-size:10pt;margin:0pt;">(Registrant)</p></td></tr><tr><td style="vertical-align:bottom;width:49.74%;margin:0pt;padding:0pt;"><p style="font-family:'Times New Roman','Times','serif';font-size:10pt;margin:0pt;"><span style="visibility:hidden;">&#8203;</span></p></td><td style="vertical-align:bottom;width:4.03%;margin:0pt;padding:0pt;"><p style="font-family:'Times New Roman','Times','serif';font-size:10pt;margin:0pt;"><span style="visibility:hidden;">&#8203;</span></p></td><td style="vertical-align:bottom;width:46.21%;margin:0pt;padding:0pt;"><p style="font-family:'Times New Roman','Times','serif';font-size:10pt;margin:0pt;"><span style="visibility:hidden;">&#8203;</span></p></td></tr><tr><td style="vertical-align:bottom;width:49.74%;margin:0pt;padding:0pt;"><p style="font-family:'Times New Roman','Times','serif';font-size:10pt;margin:0pt;"><span style="white-space:pre-wrap;">Date:  April 18, 2022</span></p></td><td style="vertical-align:bottom;width:4.03%;margin:0pt;padding:0pt;"><p style="font-family:'Times New Roman','Times','serif';font-size:10pt;margin:0pt;">By:</p></td><td style="vertical-align:bottom;width:46.21%;border-bottom:1px solid #000000;margin:0pt;padding:0pt;"><p style="font-family:'Times New Roman','Times','serif';font-size:10pt;margin:0pt;">/s/ Sean A. Power</p></td></tr><tr><td style="vertical-align:bottom;width:49.74%;margin:0pt;padding:0pt;"><p style="font-family:'Times New Roman','Times','serif';font-size:10pt;margin:0pt;"><span style="visibility:hidden;">&#8203;</span></p></td><td style="vertical-align:bottom;width:4.03%;margin:0pt;padding:0pt;"><p style="font-family:'Times New Roman','Times','serif';font-size:10pt;margin:0pt;"><span style="visibility:hidden;">&#8203;</span></p></td><td style="vertical-align:bottom;width:46.21%;border-top:1px solid #000000;margin:0pt;padding:0pt;"><p style="font-family:'Times New Roman','Times','serif';font-size:10pt;margin:0pt;"><span style="white-space:pre-wrap;"> Sean A. Power</span></p></td></tr><tr><td style="vertical-align:bottom;width:49.74%;margin:0pt;padding:0pt;"><p style="font-family:'Times New Roman','Times','serif';font-size:10pt;margin:0pt;"><span style="visibility:hidden;">&#8203;</span></p></td><td style="vertical-align:bottom;width:4.03%;margin:0pt;padding:0pt;"><p style="font-family:'Times New Roman','Times','serif';font-size:10pt;margin:0pt;"><span style="visibility:hidden;">&#8203;</span></p></td><td style="vertical-align:bottom;width:46.21%;margin:0pt;padding:0pt;"><p style="font-family:'Times New Roman','Times','serif';font-size:10pt;margin:0pt;"><span style="white-space:pre-wrap;"> Chief Financial Officer</span></p></td></tr></table><p style="font-family:'Times New Roman','Times','serif';font-size:10pt;margin:0pt;"><span style="font-size:1pt;visibility:hidden;">&#8203;</span></p><p style="font-family:'Times New Roman','Times','serif';font-size:10pt;margin:0pt;"><span style="visibility:hidden;">&#8203;</span></p><p style="font-family:'Times New Roman','Times','serif';font-size:10pt;margin:0pt;"><span style="visibility:hidden;">&#8203;</span></p></div><div style="clear:both;margin-bottom:30pt;width:100%;"><p style="font-family:'Times New Roman','Times','serif';font-size:10pt;text-align:center;margin:24pt 0pt 0pt 0pt;">- 3 -</p></div></div>
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​
​
UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
WASHINGTON, D.C. 20549
FORM
8-K
CURRENT REPORT
Pursuant to Section 13 or 15(d) of the
Securities Exchange Act of 1934
Date of report (Date of earliest event reported):
April 15, 2022
TG Therapeutics, Inc.
(Exact Name of Registrant as Specified in Charter)
​
​
​
Delaware
001-32639
36-3898269
(State or Other Jurisdiction
(Commission File Number)
(IRS Employer Identification No.)
of Incorporation)
​
​
​
2 Gansevoort Street
,
9
th
Floor
New York
,
New York
10014
(Address of Principal Executive Offices)
(
212
)
554-4484
(Registrant's telephone number, including area code)
Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions:
☐
Written communications pursuant to Rule 425 under the Securities Act.
☐
Soliciting material pursuant to Rule 14a-12 under the Exchange Act.
☐
Pre-commencement communications pursuant to Rule 14d-2b under the Exchange Act.
☐
Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act.
Indicate by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (17 CFR §230.405) or Rule 12b-2 of the Securities Exchange Act of 1934 (17 CFR §240.12b-2). Emerging growth company
☐
If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act.
☐
​
​
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
Press Release, dated April 15, 2022.
​
​
Exhibit 104
The cover page from this Current Report on Form 8-K formatted in Inline XBRL.
​
​
​
​
- 2 -
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
​
​
​
- 3 -