FDA Approval for UKONIQ

2/5/21 1:35:26 PM ET

$TGTX

Biotechnology: Pharmaceutical Preparations

Health Care

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New Drug Application (NDA): 213176
Company: TG THERAPEUTICS INC

Products on NDA 213176

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
UKONIQ	UMBRALISIB	200MG	TABLET;ORAL	Prescription	None	TBD	No

Approval Date(s) and History, Letters, Labels, Reviews for NDA 213176

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
02/05/2021	ORIG-2	Approval	Type 1 - New Molecular Entity	PRIORITY		Label is not available on this site.
02/05/2021	ORIG-1	Approval	Type 1 - New Molecular Entity	PRIORITY		Label is not available on this site.

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Recent Analyst Ratings for
$TGTX

Date	Price Target	Rating	Analyst
10/6/2025	$60.00	Buy	H.C. Wainwright
7/10/2025	$37.00	Neutral	Goldman
10/29/2024	$50.00	Buy	TD Cowen
8/2/2023	$16.00 → $12.00	Sell → Neutral	Goldman
6/26/2023	$55.00 → $40.00	Buy	Jefferies
5/20/2022	$5.00	Underperform	BofA Securities
2/23/2022	$49.00 → $35.00	Buy	B. Riley Securities
1/28/2022	$70.00 → $68.00	Buy	HC Wainwright & Co.

More analyst ratings

FDA Approval for UKONIQ

2/5/21 1:35:26 PM ET

$TGTX

Biotechnology: Pharmaceutical Preparations

Health Care

Get the next $TGTX alert in real time by email

New Drug Application (NDA): 213176
Company: TG THERAPEUTICS INC

Products on NDA 213176

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
UKONIQ	UMBRALISIB	200MG	TABLET;ORAL	Prescription	None	TBD	No

Approval Date(s) and History, Letters, Labels, Reviews for NDA 213176

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
02/05/2021	ORIG-2	Approval	Type 1 - New Molecular Entity	PRIORITY		Label is not available on this site.
02/05/2021	ORIG-1	Approval	Type 1 - New Molecular Entity	PRIORITY		Label is not available on this site.

Get the next $TGTX alert in real time by email

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Recent Analyst Ratings for
$TGTX

Date	Price Target	Rating	Analyst
10/6/2025	$60.00	Buy	H.C. Wainwright
7/10/2025	$37.00	Neutral	Goldman
10/29/2024	$50.00	Buy	TD Cowen
8/2/2023	$16.00 → $12.00	Sell → Neutral	Goldman
6/26/2023	$55.00 → $40.00	Buy	Jefferies
5/20/2022	$5.00	Underperform	BofA Securities
2/23/2022	$49.00 → $35.00	Buy	B. Riley Securities
1/28/2022	$70.00 → $68.00	Buy	HC Wainwright & Co.

More analyst ratings

$TGTX
Press Releases

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New Data for BRIUMVI® Demonstrate 89.9% of Patients with Relapsing Multiple Sclerosis Were Free from Disability Progression After 6 Years of Continuous BRIUMVI Treatment

During year 6 of continuous treatment with BRIUMVI the annualized relapse rate was 0.012, equivalent to one relapse occurring every 83 years of patient treatment Overall safety profile of BRIUMVI remained consistent over 6 years of continuous treatment, with no new safety signals emerging with prolonged treatment NEW YORK, Sept. 24, 2025 (GLOBE NEWSWIRE) -- TG Therapeutics, Inc. (NASDAQ:TGTX), today announced updated data presentations including new six-year data from the ULTIMATE I & II Phase 3 trials evaluating BRIUMVI® (ublituximab-xiiy) in patients with relapsing forms of multiple sclerosis (RMS), at the 2025 European Committee for Treatment and Research in Multiple Sclerosis (ECTRIM

9/24/25 9:10:00 AM ET

$TGTX

Biotechnology: Pharmaceutical Preparations

Health Care

TG Therapeutics Announces Schedule of Data Presentations for BRIUMVI® in Multiple Sclerosis at the 2025 European Committee for Treatment and Research in Multiple Sclerosis Annual Meeting

NEW YORK, Sept. 10, 2025 (GLOBE NEWSWIRE) -- TG Therapeutics, Inc. (NASDAQ:TGTX), today announced the upcoming schedule of presentations highlighting BRIUMVI® (ublituximab-xiiy) data in patients with relapsing forms of multiple sclerosis (RMS), at the 2025 European Committee for Treatment and Research in Multiple Sclerosis (ECTRIMS) annual meeting, being held September 24 - 26, 2025 in Barcelona, Spain. Abstracts are now available online and can be accessed on the ECTRIMS meeting website or at the following link: ECTRIMS 2025 PROGRAMME. Details of the upcoming presentations are outlined below. TG PRESENTATIONS:Oral Presentation: Long-term Efficacy and Safety of Ublituximab in Relapsing Mu

9/10/25 7:30:52 AM ET

$TGTX

Biotechnology: Pharmaceutical Preparations

Health Care

TG Announces Phase 3 Trial for Subcutaneous BRIUMVI Commenced Enrollment

NEW YORK, Sept. 08, 2025 (GLOBE NEWSWIRE) -- TG Therapeutics, Inc. (NASDAQ:TGTX), announced today that enrollment has commenced in a Phase 3 trial evaluating subcutaneous BRIUMVI (ublituximab-xiiy), the company's anti-CD20 monoclonal antibody, in people with relapsing forms of multiple sclerosis (RMS). BRIUMVI is currently approved in the United States, as well as several ex-US territories, as a one-hour intravenous (IV) infusion administered twice a year, following the starting dose, in adults with RMS. Michael S. Weiss, the Company's Chairman and Chief Executive Officer, stated, "We are very pleased to announce the commencement of patient enrollment in our Phase 3 trial of subcutaneous

9/8/25 7:30:00 AM ET

$TGTX

Biotechnology: Pharmaceutical Preparations

Health Care

$TGTX
Financials

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TG Therapeutics Reports Second Quarter 2025 Financial Results and Raises BRIUMVI Revenue Guidance

Second quarter 2025 total revenue of $141.1 million, including BRIUMVI U.S. net revenue of $138.8 million Raises full year 2025 BRIUMVI U.S. net revenue target to approximately $570 - $575 million Conference call to be held today, Monday, August 4, 2025, at 8:30 AM ET NEW YORK, Aug. 04, 2025 (GLOBE NEWSWIRE) -- TG Therapeutics, Inc. (NASDAQ:TGTX) (the Company or TG Therapeutics) today announced its financial results for the second quarter of 2025, along with recent company developments, and provided an update on 2025 revenue guidance. Michael S. Weiss, the Company's Chairman and Chief Executive Officer, stated, "We're incredibly proud of the continued momentum behind BRIUMVI, which

8/4/25 7:00:00 AM ET

$TGTX

Biotechnology: Pharmaceutical Preparations

Health Care

TG Therapeutics to Host Conference Call on Second Quarter 2025 Financial Results and Business Update

NEW YORK, July 30, 2025 (GLOBE NEWSWIRE) -- TG Therapeutics, Inc. (NASDAQ:TGTX), today announced that a conference call will be held, Monday, August 4, 2025, at 8:30 AM ET to discuss results for the second quarter of 2025 and provide a business outlook for the remainder of 2025. Michael S. Weiss, Chairman and Chief Executive Officer, will host the call. In order to participate in the conference call, please call 1-877-407-8029 (U.S.), 1-201-689-8029 (outside the U.S.), Conference Title: TG Therapeutics Earnings Call. A live webcast of this presentation will be available on the Events page, located within the Investors & Media section, of the Company's website at www.tgtherapeutics.com. An

7/30/25 7:30:00 AM ET

$TGTX

Biotechnology: Pharmaceutical Preparations

Health Care

TG Therapeutics Reports First Quarter 2025 Financial Results and Raises BRIUMVI Full Year Revenue Guidance

First quarter 2025 BRIUMVI U.S. net revenue of $119.7 million Raises full year 2025 global net revenue target to approximately $575 million and raises full year BRIUMVI U.S. net revenue target to approximately $560 million Conference call to be held today, Monday, May 5, 2025, at 8:30 AM ET NEW YORK, May 05, 2025 (GLOBE NEWSWIRE) -- TG Therapeutics, Inc. (NASDAQ:TGTX) (the Company or TG Therapeutics) today announced its financial results for the first quarter of 2025, along with recent company developments and provided an update on 2025 revenue guidance. Michael S. Weiss, the Company's Chairman and Chief Executive Officer, stated, "2025 is off to a strong start, and I'm incredibly

5/5/25 7:00:00 AM ET

$TGTX

Biotechnology: Pharmaceutical Preparations

Health Care

FDA Approval for UKONIQ

Products on NDA 213176

Approval Date(s) and History, Letters, Labels, Reviews for NDA 213176

Original Approvals or Tentative Approvals

Crush Q3 2025 with the Best AI Superconnector

Recent Analyst Ratings for $TGTX

FDA Approval for UKONIQ

Products on NDA 213176

Approval Date(s) and History, Letters, Labels, Reviews for NDA 213176

Original Approvals or Tentative Approvals

Crush Q3 2025 with the Best AI Superconnector

Recent Analyst Ratings for $TGTX

$TGTX Insider Trading

Director Lonial Sagar sold $672,268 worth of shares (20,852 units at $32.24), decreasing direct ownership by 18% to 94,061 units (SEC Form 4)

Director Echelard Yann was granted 14,718 shares and sold $369,400 worth of shares (10,000 units at $36.94), increasing direct ownership by 2% to 228,816 units (SEC Form 4)

Director Charney Laurence N was granted 21,408 shares, increasing direct ownership by 11% to 222,887 units (SEC Form 4)

$TGTX FDA approvals

FDA Approval for BRIUMVI issued to TG THERAPEUTICS, INC

FDA Approval for BRIUMVI issued to TG THERAPEUTICS, INC