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
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.
1/24/2022	$75.00 → $70.00	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

Crush Q3 2025 with the Best AI Executive Assistant

Stay ahead of the competition with Tailforce.ai - your AI-powered business intelligence partner.

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Recent Analyst Ratings for
$TGTX

Date	Price Target	Rating	Analyst
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.
1/24/2022	$75.00 → $70.00	Buy	HC Wainwright & Co.

More analyst ratings

$TGTX
Press Releases

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TG Therapeutics to Participate in the Goldman Sachs 46th Annual Global Healthcare Conference
NEW YORK, June 06, 2025 (GLOBE NEWSWIRE) -- TG Therapeutics, Inc. (NASDAQ:TGTX) today announced that Michael S. Weiss, the Company's Chairman and Chief Executive Officer, will participate in the Goldman Sachs 46th Annual Global Healthcare Conference, being held in Miami, FL on June 9-11, 2025. The fireside chat is scheduled to take place on Tuesday, June 10, 2025, at 10:40am ET. A live webcast of the fireside chat will be available on the Events page, located within the Investors & Media section, of the Company's website at http://ir.tgtherapeutics.com/events. ABOUT TG THERAPEUTICSTG Therapeutics is a fully integrated, commercial stage, biopharmaceutical company focused on the acquisitio
6/6/25 7:30:00 AM ET
$TGTX
Biotechnology: Pharmaceutical Preparations
Health Care
TG Therapeutics to Participate in the Jefferies Global Healthcare Conference
NEW YORK, June 02, 2025 (GLOBE NEWSWIRE) -- TG Therapeutics, Inc. (NASDAQ:TGTX) today announced that Michael S. Weiss, the Company's Chairman and Chief Executive Officer, will participate in the Jefferies Global Healthcare Conference, being held at the Marriott Marquis, in New York City on June 3-5, 2025. The fireside chat is scheduled to take place on Wednesday, June 4, 2025, at 12:50 PM ET. A live webcast of the fireside chat will be available on the Events page, located within the Investors & Media section, of the Company's website at http://ir.tgtherapeutics.com/events. ABOUT TG THERAPEUTICSTG Therapeutics is a fully integrated, commercial stage, biopharmaceutical company focused on
6/2/25 8:00:00 AM ET
$TGTX
Biotechnology: Pharmaceutical Preparations
Health Care
TG Therapeutics Announces Data Presentations for BRIUMVI in Multiple Sclerosis at the 2025 Consortium of Multiple Sclerosis Centers Annual Meeting
NEW YORK, May 30, 2025 (GLOBE NEWSWIRE) -- TG Therapeutics, Inc. (NASDAQ:TGTX), today announced the presentations of data highlighting BRIUMVI® (ublituximab-xiiy) in patients with relapsing forms of multiple sclerosis (RMS), at the 2025 Consortium of Multiple Sclerosis Centers (CMSC) annual meeting. Links to each presentation are included below. "We were pleased to present three encore presentations yesterday during the CMSC conference. We continue to be impressed by the BRIUMVI data and look forward to continuing to present updated data throughout the year."TG PRESENTATIONS:Title: No Association between Decreases in Serum Immunoglobulin Levels and Serious Infections w
5/30/25 7:30:00 AM ET
$TGTX
Biotechnology: Pharmaceutical Preparations
Health Care

$TGTX
Financials

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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
TG Therapeutics to Host Conference Call on First Quarter 2025 Financial Results and Business Update
NEW YORK, April 30, 2025 (GLOBE NEWSWIRE) -- TG Therapeutics, Inc. (NASDAQ:TGTX), today announced that a conference call will be held, Monday, May 5, 2025, at 8:30 AM ET to discuss results for the first 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 au
4/30/25 7:30:00 AM ET
$TGTX
Biotechnology: Pharmaceutical Preparations
Health Care
TG Therapeutics Provides Business Update and Reports Fourth Quarter and Full Year 2024 Financial Results
Fourth quarter and full year 2024 BRIUMVI U.S. net revenue of $103.6 million and $310 million, respectively Target guidance of approximately $540 million in total global revenue for 2025 Conference call to be held today, March 3, 2025, at 8:30 AM ET NEW YORK, March 03, 2025 (GLOBE NEWSWIRE) -- TG Therapeutics, Inc. (NASDAQ:TGTX) (the Company or TG Therapeutics) today announced its financial results for the fourth quarter and full year ended December 31, 2024, along with recent company developments. Michael S. Weiss, the Company's Chairman and Chief Executive Officer, stated,
3/3/25 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 Executive Assistant

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 Executive Assistant

Recent Analyst Ratings for $TGTX

$TGTX SEC Filings

TG Therapeutics Inc. filed SEC Form 8-K: Submission of Matters to a Vote of Security Holders, Financial Statements and Exhibits

SEC Form SCHEDULE 13G filed by TG Therapeutics Inc.

SEC Form 10-Q filed by TG Therapeutics Inc.

$TGTX Analyst Ratings

Analyst ratings in real time. Analyst ratings have a very high impact on the underlying stock. See them live in this feed.

Goldman resumed coverage on TG Therapeutics with a new price target

TD Cowen initiated coverage on TG Therapeutics with a new price target

TG Therapeutics upgraded by Goldman with a new price target

$TGTX Insider Trading

Insider transactions reveal critical sentiment about the company from key stakeholders. See them live in this feed.

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)

Director Hoberman Kenneth was granted 14,718 shares, increasing direct ownership by 6% to 279,653 units (SEC Form 4)

$TGTX Press Releases

Fastest customizable press release news feed in the world

TG Therapeutics to Participate in the Goldman Sachs 46th Annual Global Healthcare Conference

TG Therapeutics to Participate in the Jefferies Global Healthcare Conference

TG Therapeutics Announces Data Presentations for BRIUMVI in Multiple Sclerosis at the 2025 Consortium of Multiple Sclerosis Centers Annual Meeting

$TGTX FDA approvals

Live FDA approvals issued by the Food and Drug Administration and FDA breaking news

FDA Approval for BRIUMVI issued to TG THERAPEUTICS, INC

FDA Approval for BRIUMVI issued to TG THERAPEUTICS, INC