<SEC-DOCUMENT>0001654954-17-006791.txt : 20170801
<SEC-HEADER>0001654954-17-006791.hdr.sgml : 20170801
<ACCEPTANCE-DATETIME>20170801073543
ACCESSION NUMBER:		0001654954-17-006791
CONFORMED SUBMISSION TYPE:	8-K
PUBLIC DOCUMENT COUNT:		2
CONFORMED PERIOD OF REPORT:	20170801
ITEM INFORMATION:		Other Events
ITEM INFORMATION:		Financial Statements and Exhibits
FILED AS OF DATE:		20170801
DATE AS OF CHANGE:		20170801

FILER:

	COMPANY DATA:	
		COMPANY CONFORMED NAME:			TG THERAPEUTICS, INC.
		CENTRAL INDEX KEY:			0001001316
		STANDARD INDUSTRIAL CLASSIFICATION:	PHARMACEUTICAL PREPARATIONS [2834]
		IRS NUMBER:				363898269
		STATE OF INCORPORATION:			DE
		FISCAL YEAR END:			1231

	FILING VALUES:
		FORM TYPE:		8-K
		SEC ACT:		1934 Act
		SEC FILE NUMBER:	001-32639
		FILM NUMBER:		17994965

	BUSINESS ADDRESS:	
		STREET 1:		2 GANSEVOORT STREET, 9TH FLOOR
		CITY:			NEW YORK
		STATE:			NY
		ZIP:			10014
		BUSINESS PHONE:		(212) 554-4484

	MAIL ADDRESS:	
		STREET 1:		2 GANSEVOORT STREET, 9TH FLOOR
		CITY:			NEW YORK
		STATE:			NY
		ZIP:			10014

	FORMER COMPANY:	
		FORMER CONFORMED NAME:	MANHATTAN PHARMACEUTICALS INC
		DATE OF NAME CHANGE:	20030310

	FORMER COMPANY:	
		FORMER CONFORMED NAME:	ATLANTIC TECHNOLOGY VENTURES INC
		DATE OF NAME CHANGE:	20000330

	FORMER COMPANY:	
		FORMER CONFORMED NAME:	ATLANTIC PHARMACEUTICALS INC
		DATE OF NAME CHANGE:	19960703
</SEC-HEADER>
<DOCUMENT>
<TYPE>8-K
<SEQUENCE>1
<FILENAME>v080117_8k.htm
<DESCRIPTION>8-K
<TEXT>
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<div style="text-align: center; margin-left: 0px; margin-right: 19px; text-indent: 0px"><font style="font-size: 13px; font-family: Times New Roman"><font style="font-weight: bold">UNITED STATES</font></font></div>
<div style="text-align: center; margin-left: 0px; margin-right: 19px; text-indent: 0px"><font style="font-size: 13px; font-family: Times New Roman"><font style="font-weight: bold">SECURITIES AND EXCHANGE
COMMISSION</font></font></div>
<div style="text-align: center; margin-left: 0px; margin-right: 19px; text-indent: 0px"><font style="font-size: 13px; font-family: Times New Roman"><font style="font-weight: bold">WASHINGTON, D.C.</font> <font style="font-weight: bold"><font style="font-size: 13px">20549</font></font></font></div>
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<div style="text-align: center; margin-left: 0px; margin-right: 19px; text-indent: 0px"><font style="font-size: 13px; font-family: Times New Roman"><font style="font-weight: bold">FORM 8-K</font></font></div>
<div style="text-align: center; margin-left: 0px; margin-right: 19px; text-indent: 0px"><font style="font-size: 13px; font-family: Times New Roman"><font style="font-weight: bold">_____________</font></font></div>
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<div style="text-align: center; margin-left: 0px; margin-right: 19px; text-indent: 0px"><font style="font-size: 13px; font-family: Times New Roman"><font style="font-weight: bold">CURRENT REPORT</font></font></div>
<div style="text-align: center; margin-left: 0px; margin-right: 19px; text-indent: 0px"><font style="font-size: 13px; font-family: Times New Roman"><font style="font-weight: bold">Pursuant to Section 13 or 15(d) of
the</font></font></div>
<div style="text-align: center; margin-left: 0px; margin-right: 19px; text-indent: 0px"><font style="font-size: 13px; font-family: Times New Roman"><font style="font-weight: bold">Securities Exchange Act of
1934</font></font></div>
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<div style="text-align: left; margin-left: 0px; margin-right: 19px; text-indent: 0px"></div>
<div style="text-align: center; margin-left: 0px; margin-right: 19px; text-indent: 0px"><font style="font-size: 13px; font-family: Times New Roman">Date of report
(Date of earliest event reported): <font style="font-weight: bold">August 1, 2017</font></font></div>
<div style="text-align: center; margin-left: 0px; margin-right: 19px; text-indent: 0px"></div>
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<div style="text-align: left; margin-left: 0px; margin-right: 19px; text-indent: 0px"><font style="font-size: 13px; font-family: Times New Roman">&#xA0;</font></div>
<div style="text-align: center; margin-left: 0px; margin-right: 19px; text-indent: 0px"><font style="font-size: 13px; font-family: Times New Roman"><font style="font-weight: bold">TG Therapeutics, Inc.</font></font></div>
<div style="text-align: center; margin-left: 0px; margin-right: 19px; text-indent: 0px"><font style="font-size: 13px; font-family: Times New Roman">(Exact Name of
Registrant as Specified in Charter)</font></div>
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<div style="text-align: left; margin-left: 0px; margin-right: 19px; text-indent: 0px"><font style="font-size: 13px; font-family: Times New Roman">&#xA0;</font></div>
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<div style="text-align: center; margin-left: 12px; margin-right: 19px; text-indent: 0px"><font style="font-size: 13px; font-family: Times New Roman"><font style="font-weight: bold">Delaware</font></font></div>
<div style="text-align: center; margin-left: 12px; margin-right: 19px; text-indent: 0px"><font style="font-size: 13px; font-family: Times New Roman">(State or Other
Jurisdiction</font></div>
<div style="text-align: center; margin-left: 12px; margin-right: 19px; text-indent: 0px"><font style="font-size: 13px; font-family: Times New Roman">of
Incorporation)</font></div>
</td>
<td style="width: 29%">
<div style="text-align: center; margin-left: 12px; margin-right: 19px; text-indent: 0px"><font style="font-size: 13px; font-family: Times New Roman"><font style="font-weight: bold">001-32639</font></font></div>
<div style="text-align: center; margin-left: 12px; margin-right: 19px; text-indent: 0px"><font style="font-size: 13px; font-family: Times New Roman">(Commission File
Number)</font></div>
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<div style="text-align: center; margin-left: 12px; margin-right: 19px; text-indent: 0px"><font style="font-size: 13px; font-family: Times New Roman"><font style="font-weight: bold">36-3898269</font></font></div>
<div style="text-align: center; margin-left: 12px; margin-right: 19px; text-indent: 0px"><font style="font-size: 13px; font-family: Times New Roman">(IRS Employer
Identification No.)</font></div>
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<div style="text-align: left; margin-left: 0px; margin-right: 19px; text-indent: 0px"><font style="font-size: 13px; font-family: Times New Roman">&#xA0;</font></div>
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<div style="text-align: left; margin-left: 0px; margin-right: 19px; text-indent: 0px"></div>
<div style="text-align: center; margin-left: 0px; margin-right: 19px; text-indent: 0px"><font style="font-size: 13px; font-family: Times New Roman"><font style="font-weight: bold">2 Gansevoort Street, 9<font style="vertical-align: super; font-size: 70%">th</font>
Floor</font></font></div>
<div style="text-align: center; margin-left: 0px; margin-right: 19px; text-indent: 0px"><font style="font-size: 13px; font-family: Times New Roman"><font style="font-weight: bold">New York, New York 10014</font></font></div>
<div style="text-align: center; margin-left: 0px; margin-right: 19px; text-indent: 0px"><font style="font-size: 13px; font-family: Times New Roman">(Address of
Principal Executive Offices)</font></div>
<div style="text-align: left; margin-left: 0px; margin-right: 19px; text-indent: 0px"><font style="font-size: 13px; font-family: Times New Roman">&#xA0;</font></div>
<div style="text-align: center; margin-left: 0px; margin-right: 19px; text-indent: 0px"><font style="font-size: 13px; font-family: Times New Roman"><font style="font-weight: bold">(212) 554-4484</font></font></div>
<div style="text-align: center; margin-left: 0px; margin-right: 19px; text-indent: 0px"><font style="font-size: 13px; font-family: Times New Roman">(Registrant's
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<div style="text-align: left; margin-left: 0px; margin-right: 19px; text-indent: 0px"><font style="font-size: 13px; font-family: Times New Roman">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:</font></div>
<div style="text-align: left; margin-left: 0px; margin-right: 19px; text-indent: 0px"><font style="font-size: 13px; font-family: Times New Roman">&#xA0;</font></div>
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</td>
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<div style="text-align: left; margin-left: 0px; margin-right: 0px; text-indent: 0px"><font>Written communications pursuant to Rule 425
under the Securities Act.</font></div>
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</td>
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</td>
<td>
<div style="text-align: left; margin-left: 0px; margin-right: 0px; text-indent: 0px"><font>Soliciting material pursuant to Rule 14a-12
under the Exchange Act.</font></div>
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</td>
<td>
<div style="text-align: left; margin-left: 0px; margin-right: 0px; text-indent: 0px"><font>Pre-commencement communications pursuant to Rule
14d-2b under the Exchange Act.</font></div>
</td>
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</div>
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<div style="text-align: left; margin-left: 0px; margin-right: 0px; text-indent: 0px"><font>Pre-commencement communications pursuant to Rule
13e-4(c) under the Exchange Act.</font></div>
</td>
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</div>
<div style="text-align: left; margin-left: 0px; margin-right: 19px; text-indent: 0px"><font style="font-size: 13px; font-family: Times New Roman"><font style="font-weight: bold">&#xA0;</font></font></div>
<div style="text-align: left; margin-left: 0px; margin-right: 19px; text-indent: 0px"><font style="font-size: 13px; font-family: Times New Roman">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
&#xA7;230.405) or Rule 12b-2 of the Securities Exchange Act of 1934
(17 CFR &#xA7;240.12b-2). Emerging growth company
&#x2610;</font></div>
<div style="text-align: left; margin-left: 0px; margin-right: 19px; text-indent: 0px"><font style="font-size: 13px; font-family: Times New Roman">&#xA0;</font></div>
<div style="text-align: left; margin-left: 0px; margin-right: 19px; text-indent: 0px"><font style="font-size: 13px; font-family: Times New Roman">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.</font> <font style="font-size: 13px; font-family: Times New Roman">&#x2610;</font></div>
<div style="text-align: left; margin-left: 0px; margin-right: 19px; text-indent: 0px"><font style="font-size: 13px; font-family: Times New Roman">&#xA0;</font></div>
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<div style="text-align: right; margin-left: 0px; margin-right: 0px; text-indent: 0px; width: 100%"><font style="font-size: 13px; font-family: Times New Roman">&#xA0;</font></div>
</div>
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<div style="text-align: left; margin-left: 0px; margin-right: 0px; text-indent: 0px"><font>&#xA0;</font></div>
<div style="text-align: left; margin-left: 0px; margin-right: 0px; text-indent: 0px"><font style="font-size: 13px; font-family: Times New Roman"><font style="font-weight: bold">Item 8.01. Other Events.</font></font></div>
<div style="text-align: left; margin-left: 0px; margin-right: 0px; text-indent: 0px"><font style="font-size: 13px; font-family: Times New Roman"><font style="font-weight: bold">&#xA0;</font></font></div>
<div style="text-align: left; margin-left: 0px; margin-right: 19px; text-indent: 48px"><font style="font-size: 13px; font-family: Times New Roman">&#xA0;&#xA0;
<font style="font-family: Times New Roman; font-size: 13px">On
August 1, 2017, TG Therapeutics, Inc. (the &#x201C;Company&#x201D;)
issued a press release announcing it has reached an agreement with
the U.S. Food and Drug Administration (FDA) regarding a Special
Protocol Assessment (SPA) on the design of two Phase 3 clinical
trials for TG-1101 (ublituximab), the Company&#x2019;s
glycoengineered anti-CD20 monoclonal antibody, for the treatment of
relapsing forms of Multiple Sclerosis (RMS). A copy of the press
release is being filed as Exhibit 99.1 and is incorporated herein
by reference</font>.<br></font></div>
<div style="text-align: justify; margin-left: 0px; margin-right: 0px; text-indent: 48px"><font style="font-size: 13px; font-family: Times New Roman">&#xA0;</font></div>
<div style="text-align: left; margin-left: 0px; margin-right: 0px; text-indent: 0px"><font style="font-size: 13px; font-family: Times New Roman"><font style="font-weight: bold">Item 9.01 Financial Statements And
Exhibits.</font></font></div>
<div style="text-align: left; margin-left: 0px; margin-right: 0px; text-indent: 0px"><font style="font-size: 13px; font-family: Times New Roman">&#xA0;</font></div>
<div style="text-align: left; margin-left: 0px; margin-right: 0px; text-indent: 0px"><font style="font-size: 13px; font-family: Times New Roman">(d)
Exhibits.</font></div>
<div style="text-align: left; margin-left: 0px; margin-right: 0px; text-indent: 0px"><font style="font-size: 13px; font-family: Times New Roman">&#xA0;</font></div>
<div style="text-align: left; margin-left: 48px; margin-right: 0px; text-indent: -48px"><font style="font-size: 13px; font-family: Times New Roman">99.1&#xA0; Press
Release, dated August 1, 2017.</font></div>
<br>
<div style="text-align: left; margin-left: 48px; margin-right: 0px; text-indent: -48px"><font style="font-size: 13px; font-family: Times New Roman">&#xA0;</font></div>
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<div style="text-align: right; margin-left: 0px; margin-right: 0px; text-indent: 0px; width: 100%"><font style="font-size: 13px; font-family: Times New Roman">&#xA0;</font></div>
</div>
</div>
<div style="text-align: left; margin-left: 48px; margin-right: 0px; text-indent: -48px"><font style="font-size: 13px; font-family: Times New Roman">&#xA0;</font></div>
<div style="text-align: center; margin-left: 48px; margin-right: 0px; text-indent: -48px"><font style="font-size: 13px; font-family: Times New Roman"><font style="font-weight: bold">SIGNATURES</font></font></div>
<div style="text-align: justify; margin-left: 0px; margin-right: 19px; text-indent: 0px"></div>
<div style="text-align: justify; margin-left: 0px; margin-right: 19px; text-indent: 0px"><font style="font-size: 13px; font-family: Times New Roman">&#xA0;</font></div>
<div style="text-align: justify; margin-left: 0px; margin-right: 0px; text-indent: 48px"><font style="font-size: 13px; font-family: Times New Roman">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.</font></div>
<div style="text-align: justify; margin-left: 0px; margin-right: 19px; text-indent: 0px"><font style="font-size: 13px; font-family: Times New Roman">&#xA0;</font></div>
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<div style="text-align: left; margin-left: 0px; margin-right: 0px; text-indent: 0px"><font>&#xA0;</font></div>
</td>
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<div style="text-align: left; margin-left: 0px; margin-right: 0px; text-indent: 0px"><font style="font-size: 13px; font-family: Times New Roman"><font style="font-weight: bold">TG Therapeutics, Inc.</font></font></div>
</td>
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<div style="text-align: justify; margin-left: 0px; margin-right: 0px; text-indent: 0px"><font>&#xA0;</font></div>
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<div style="text-align: justify; margin-left: 0px; margin-right: 0px; text-indent: 0px"><font style="font-size: 13px; font-family: Times New Roman">(Registrant)</font></div>
</td>
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<td style="text-indent: 0; padding-bottom: 0px">
<div style="text-align: justify; margin-left: 0px; margin-right: 0px; text-indent: 0px"><font>&#xA0;</font></div>
</td>
<td style="text-indent: 0; padding-bottom: 0px">
<div style="text-align: justify; margin-left: 0px; margin-right: 0px; text-indent: 0px"><font>&#xA0;</font></div>
</td>
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<td style="text-indent: 0; padding-bottom: 0px">
<div style="text-align: justify; margin-left: 0px; margin-right: 0px; text-indent: 0px"><font>&#xA0;</font></div>
</td>
<td style="text-indent: 0; padding-bottom: 0px">
<div style="text-align: justify; margin-left: 0px; margin-right: 0px; text-indent: 0px"><font>&#xA0;</font></div>
</td>
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<td style="text-indent: 0; padding-bottom: 0px">
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<div style="text-align: justify; margin-left: 0px; margin-right: 0px; text-indent: 0px"><font style="font-size: 13px; font-family: Times New Roman">Date: August 1,
2017</font></div>
</td>
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<td style="text-indent: 0; padding-bottom: 0px">
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</td>
<td style="text-indent: 0; padding-bottom: 0px">
<div style="text-align: left; margin-left: 0px; margin-right: 0px; text-indent: 0px"><font style="font-size: 13px; font-family: Times New Roman">By:&#xA0;<font style="text-decoration: underline">/s/
Sean A.
Power&#xA0;&#xA0;&#xA0;&#xA0;&#xA0;&#xA0;&#xA0;&#xA0;&#xA0;&#xA0;&#xA0;&#xA0;&#xA0;</font></font></div>
</td>
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<td style="text-indent: 0; padding-bottom: 0px">
<div style="text-align: left; margin-left: 0px; margin-right: 0px; text-indent: 0px"><font>&#xA0;</font></div>
</td>
<td style="text-indent: 0; padding-bottom: 0px">
<div style="text-align: left; margin-left: 0px; margin-right: 0px; text-indent: 0px"><font style="font-size: 13px; font-family: Times New Roman">Sean A.
Power</font></div>
</td>
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<td style="text-indent: 0; padding-bottom: 0px">
<div style="text-align: left; margin-left: 0px; margin-right: 0px; text-indent: 0px"><font>&#xA0;</font></div>
</td>
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<div style="text-align: left; margin-left: 0px; margin-right: 0px; text-indent: 0px"><font style="font-size: 13px; font-family: Times New Roman">Chief Financial
Officer</font></div>
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<div style="text-align: left; margin-left: 0px; margin-right: 0px; text-indent: 0px"><font>&#xA0;</font></div>
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<div style="text-align: center; margin-left: 336px; margin-right: 19px; text-indent: -336px"><font style="font-weight: bold; font-size: 13px; font-family: Times New Roman">INDEX
TO EXHIBITS</font></div>
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<div style="text-align: left; margin-left: 0px; margin-right: 0px; text-indent: 0px"><font>&#xA0;</font></div>
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<div style="text-align: left; margin-left: 0px; margin-right: 0px; text-indent: 0px"><font>&#xA0;</font></div>
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<div style="text-align: justify; margin-left: 0px; margin-right: 0px; text-indent: 0px"><font style="font-size: 13px; font-family: Times New Roman"><font style="font-weight: bold">Exhibit</font></font></div>
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<td style="text-indent: 0; padding-bottom: 0px; text-decoration: underline">
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<td style="text-indent: 0; padding-bottom: 0px">
<div style="text-align: left; margin-left: 0px; margin-right: 0px; text-indent: 0px"><font>&#xA0;</font></div>
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<div style="text-align: left; margin-left: 0px; margin-right: 0px; text-indent: 0px"><font>&#xA0;</font></div>
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<div style="text-align: left; margin-left: 0px; margin-right: 0px; text-indent: 0px"><font style="font-size: 13px; font-family: Times New Roman">99.1</font></div>
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<div style="text-align: left; margin-left: 0px; margin-right: 0px; text-indent: 0px"><font>&#xA0;</font></div>
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<div style="text-align: left; margin-left: 0px; margin-right: 0px; text-indent: 0px"><font style="font-size: 13px; font-family: Times New Roman">Press Release,
dated August 1, 2017.</font></div>
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<TYPE>EX-99.1
<SEQUENCE>2
<FILENAME>v080117_ex991.htm
<DESCRIPTION>EXHIBIT 99.1
<TEXT>
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<title>Blueprint</title>
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<font style="font-weight: bold; font-family: Times New Roman; font-size: 16px">
TG Therapeutics Announces Special Protocol Assessment (SPA)
Agreement with the FDA for a Phase 3 Program of TG-1101
(ublituximab) for Patients with Multiple Sclerosis
(MS)</font></div>
<div><font style="font-family: Times New Roman; font-size: 10">&#xA0;</font></div>
<div style="text-align: left; margin-left: 0px; margin-right: 0px; text-indent: 0px">
<font style="font-weight: bold; font-style: italic; font-family: Times New Roman; font-size: 13px">
Global Phase 3 Program Expected to Commence Before End of Q3
2017</font></div>
<div><font style="font-family: Times New Roman; font-size: 10">&#xA0;</font></div>
<div style="text-align: left; margin-left: 0px; margin-right: 0px; text-indent: 0px">
<font style="font-weight: bold; font-style: italic; font-family: Times New Roman; font-size: 13px">
International Phase 3 Trials Entitled &#x201C;ULTIMATE I&#x201D; and
&#x201C;ULTIMATE II&#x201D; to be Led by Lawrence Steinman, MD, of
Stanford University</font></div>
<div><font style="font-family: Times New Roman; font-size: 10">&#xA0;</font></div>
<div style="text-align: left; margin-left: 0px; margin-right: 0px; text-indent: 0px">
<font style="font-family: Times New Roman; font-size: 13px">NEW
YORK, August 1, 2017&#x2013; TG Therapeutics, Inc. (Nasdaq: TGTX)
announced today that it has reached an agreement with the U.S. Food
and Drug Administration (FDA) regarding a Special Protocol
Assessment (SPA) on the design of two Phase 3 clinical trials for
TG-1101 (ublituximab), the Company&#x2019;s glycoengineered
anti-CD20 monoclonal antibody, for the treatment of relapsing forms
of Multiple Sclerosis (RMS). The SPA provides agreement that the
two Phase 3 trial designs adequately address objectives that, if
met, would support the regulatory submission for approval of
TG-1101.</font></div>
<div><font style="font-family: Times New Roman; font-size: 10">&#xA0;</font></div>
<div style="text-align: left; margin-left: 0px; margin-right: 0px; text-indent: 0px">
<font style="font-family: Times New Roman; font-size: 13px">The RMS
Phase 3 program consists of two trials, called the ULTIMATE I and
ULTIMATE II trials. Each trial is a global, randomized,
multi-center, double-blinded, double-dummy, active-controlled study
comparing TG-1101 (ublituximab) to teriflunomide in subjects with
RMS. The primary endpoint for each study is Annualized Relapse Rate
(ARR) following 96 weeks of treatment. Each trial will enroll
approximately 440 subjects, randomized in a 1:1 ratio, with
approximately 880 patients to be enrolled across both
trials.</font></div>
<div><font style="font-family: Times New Roman; font-size: 10">&#xA0;</font></div>
<div style="text-align: left; margin-left: 0px; margin-right: 0px; text-indent: 0px">
<font style="font-family: Times New Roman; font-size: 13px">Lawrence
Steinman, MD, George A. Zimmermann Professor and Professor of
Pediatrics, Neurology and Neurological Sciences at Stanford
University, and global study chair for both ULTIMATE I and ULTIMATE
II trials commented, &#x201C;B-cell targeted therapy with anti-CD20
monoclonal antibodies has been shown to be very active in the
treatment of multiple sclerosis, and with the recent approval of
ocrelizumab, we have entered a new era of B-cell targeted therapy
for MS. The Phase 2 data recently presented for ublituximab
demonstrates an encouraging safety and efficacy profile in the
treatment of MS with this novel glycoengineered anti-CD20
monoclonal antibody. We are excited to lead this global Phase 3
program, and believe the unique attributes of ublituximab, in
particular the rapid infusion times and potential pricing
advantages, may provide added convenience and enhance patient care
and access over currently available therapies.&#x201D;</font></div>
<div><font style="font-family: Times New Roman; font-size: 10">&#xA0;</font></div>
<div style="text-align: left; margin-left: 0px; margin-right: 0px; text-indent: 0px">
<font style="font-family: Times New Roman; font-size: 13px">Michael
S. Weiss, Executive Chairman and Chief Executive Officer of TG
Therapeutics, stated "Reaching agreement with the FDA on the design
of our Phase 3 program for TG-1101 in RMS has been a priority for
us and we would like to thank the FDA for its invaluable guidance
throughout this process. We have long believed the potential of
TG-1101 is beyond oncology and believe this significant Phase 3
program will establish TG-1101 as an important new drug in the
treatment of MS. The early data from our Phase 2 clinical trial,
the highly successful pivotal results for the anti-CD20 monoclonal
antibody ocrelizumab in MS, and the substantial safety data
generated in our oncology program, gives us a high level of
confidence in the potential for a successful outcome.&#x201D; Mr.
Weiss continued, &#x201C;Our team in concert with our CRO has been
hard at work on the logistics and the launch of these Phase 3
trials on a global basis, and we look forward to enrolling our
first patient before the end of the summer.&#x201D;</font></div>
<div style="text-align: left; margin-left: 0px; margin-right: 0px; text-indent: 0px"><font style="font-size: 13px; font-family: Times New Roman">&#xA0;</font></div>
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</div>
</div>
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</font></div>
<div style="text-align: left; margin-left: 0px; margin-right: 0px; text-indent: 0px"><font style="font-family: Times New Roman; font-size: 13px;">&#xA0;</font></div>
<div style="text-align: left; margin-left: 0px; margin-right: 0px; text-indent: 0px"><font style="color: #000000; font-weight: bold; font-size: 13px; font-family: Times New Roman">
ABOUT&#xA0;TG THERAPEUTICS, INC.</font></div>
<div style="text-align: left; margin-left: 0px; margin-right: 0px; text-indent: 0px"><font style="font-size: 13px; font-family: Times New Roman">&#xA0;</font></div>
<div style="text-align: left; margin-left: 0px; margin-right: 0px; text-indent: 0px">
<font style="font-family: Times New Roman; font-size: 13px">TG
Therapeutics is a biopharmaceutical company focused on the
acquisition, development and commercialization of novel treatments
for B-cell malignancies and autoimmune diseases. Currently, the
company is developing two therapies targeting hematological
malignancies and autoimmune diseases. TG-1101 (ublituximab) is a
novel, glycoengineered monoclonal antibody that targets a specific
and unique epitope on the CD20 antigen found on mature
B-lymphocytes. TG Therapeutics is also developing TGR-1202, an
orally available PI3K delta inhibitor. The delta isoform of PI3K is
strongly expressed in cells of hematopoietic origin and is believed
to be important in the proliferation and survival of
B&#x2010;lymphocytes. Both TG-1101 and TGR-1202 are in clinical
development for patients with hematologic malignancies, with
TG-1101 also in clinical development for autoimmune disorders. The
Company also has preclinical programs to develop IRAK4 inhibitors,
BET inhibitors, and anti-PD-L1 and anti-GITR antibodies. TG
Therapeutics is headquartered in New York City.</font></div>
<div style="text-align: left; margin-left: 0px; margin-right: 0px; text-indent: 0px"><font style="font-size: 13px; font-family: Times New Roman">&#xA0;</font></div>
<div style="text-align: left; margin-left: 0px; margin-right: 0px; text-indent: 0px">
<font style="font-weight: bold; font-family: Times New Roman; font-size: 13px">
About Special Protocol Assessments</font></div>
<div style="text-align: left; margin-left: 0px; margin-right: 0px; text-indent: 0px">
<font style="font-family: Times New Roman; font-size: 13px;">&#xA0;</font></div>
<div style="text-align: left; margin-left: 0px; margin-right: 0px; text-indent: 0px">
<font style="font-family: Times New Roman; font-size: 13px">The
Special Protocol Assessment (SPA) process is a procedure by which
the FDA provides official evaluation and written guidance on the
design and size of proposed protocols that are intended to form the
basis for a new drug application.</font></div>
<div><font style="font-family: Times New Roman; font-size: 10">&#xA0;</font></div>
<div style="text-align: left; margin-left: 0px; margin-right: 0px; text-indent: 0px">
<font style="font-family: Times New Roman; font-size: 13px">Final
marketing approval depends on the results of efficacy, the adverse
event profile and an evaluation of the benefit/risk of treatment
demonstrated in the Phase 3 clinical program. The SPA agreement may
only be changed through a written agreement between the sponsor and
the FDA, or if the FDA becomes aware of a substantial scientific
issue essential to product efficacy or safety. For more information
on Special Protocol Assessment, please visit: <font style="text-decoration: underline; color: #0000FF">http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/ucm080571.pdf</font>.</font></div>
<div><font style="font-family: Times New Roman; font-size: 10">&#xA0;</font></div>
<div style="text-align: left; margin-left: 0px; margin-right: 0px; text-indent: 0px">
<font style="font-weight: bold; font-family: Times New Roman; font-size: 13px">
Cautionary Statement</font></div>
<div><font style="font-family: Times New Roman; font-size: 10">&#xA0;</font></div>
<div style="text-align: left; margin-left: 0px; margin-right: 0px; text-indent: 0px">
<font style="font-family: Times New Roman; font-size: 13px">Statements
included in this press release, particularly those with respect to
anticipating the benefit of the early data seen in the Phase 2 MS
trial, as well as anticipating the timing of the release of
additional data from our Phase 2 MS trial and the timing of the
first patient enrolled into our MS Phase 3 program may be
forward-looking statements that involve a number of risks and
uncertainties. For those statements, we claim the protection of the
safe harbor for forward-looking statements contained in the Private
Securities Litigation Reform Act of 1995. Among the factors that
could cause our actual results to differ materially are the
following: our ability to successfully and cost-effectively
complete the MS Phase 2 trial; the risk that early clinical results
that supported our decision to move forward will not be reproduced
in additional patients in expansion cohorts or in the MS Phase 3
program; the risk that the clinical results from the MS Phase 3
program, will be not positive and/or will not support regulatory
approval of TG-1101 for MS; the risk that TG-1101 will not have a
differentiated profile from the other drugs in the class; the risk
that some of the perceived attributes of TG-1101, in particular the
infusion times and potential pricing advantages may not be
incorporated into future plans and other risk factors identified
from time to time in our reports filed with the Securities and
Exchange Commission. Any forward-looking statements set forth in
this press release speak only as of the date of this press release.
We do not undertake to update any of these forward-looking
statements to reflect events or circumstances that occur after the
date hereof. This press release and prior releases are available at
www.tgtherapeutics.com. The information found on our website is not
incorporated by reference into this press release and is included
for reference purposes only.</font></div>
<div><font style="font-family: Times New Roman; font-size: 10">&#xA0;</font></div>
<div style="text-align: left; margin-left: 0px; margin-right: 0px; text-indent: 0px"><font style="font-size: 13px; font-family: Times New Roman">TGTX -
G</font></div>
<div style="text-align: left; margin-left: 0px; margin-right: 0px; text-indent: 0px"><font style="font-size: 13px; font-family: Times New Roman">&#xA0;</font></div>
<div style="text-align: left; margin-left: 0px; margin-right: 0px; text-indent: 48px"><font style="font-family: Times New Roman; font-size: 13px;">Jenna
Bosco<br></font></div>
<div style="text-align: left; margin-left: 0px; margin-right: 0px; text-indent: 48px"><font style="font-size: 13px; font-family: Times New Roman">Vice President -
Investor Relations</font></div>
<div style="text-align: left; margin-left: 0px; margin-right: 0px; text-indent: 48px"><font style="font-size: 13px; font-family: Times New Roman">TG Therapeutics,
Inc.</font></div>
<div style="text-align: left; margin-left: 0px; margin-right: 0px; text-indent: 48px"><font style="font-size: 13px; font-family: Times New Roman">Telephone:
212.554.4351</font></div>
<div style="text-align: left; margin-left: 0px; margin-right: 0px; text-indent: 48px"><font style="font-size: 13px; font-family: Times New Roman">Email: <font style="color: blue"><font style="text-decoration: underline">ir@tgtxinc.com</font></font></font></div>
<div style="text-align: justify; margin-left: 0px; margin-right: 0px; text-indent: 0px"><font style="font-size: 13px; font-family: Times New Roman">&#xA0;</font></div>
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&#xA0;<br>
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