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
10/29/2024	$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.
12/1/2021	$55.00 → $36.00	Outperform	Evercore ISI Group

More analyst ratings

$TGTX
Press Releases

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TG Therapeutics Ranked Number One Fastest-Growing Company in North America on the 2024 Deloitte Technology Fast 500™
NEW YORK, Nov. 21, 2024 (GLOBE NEWSWIRE) -- TG Therapeutics, Inc. (NASDAQ:TGTX), today announced it ranked number one on the Deloitte Technology Fast 500™, a ranking of the 500 fastest-growing technology, media, telecommunications, life sciences, fintech, and energy tech companies in North America, now in its 30th year. The Company's growth between fiscal years 2020 to 2023 was fueled by BRIUMVI® revenues, which was approved to treat adult individuals with relapsing forms of multiple sclerosis in December of 2022. Michael S. Weiss, the Company's Chairman and Chief Executive Officer stated, "We are proud to be recognized as the fastest-growing c
11/21/24 6:00:00 AM ET
$TGTX
Biotechnology: Pharmaceutical Preparations
Health Care
FUJIFILM Diosynth Biotechnologies Signs Manufacturing Supply Agreement with TG Therapeutics
HOLLY SPRINGS, N.C., Nov. 04, 2024 (GLOBE NEWSWIRE) -- FUJIFILM Diosynth Biotechnologies (the Company), a world leading contract development and manufacturing organization (CDMO) for biologics, vaccines, advanced therapies, and oncolytic viruses, today announced that TG Therapeutics, Inc. (NASDAQ:TGTX) has committed to a multi-year manufacturing supply agreement for BRIUMVI® (ublitiximab-xiiy), its U.S. FDA-approved therapeutic for relapsing forms of multiple sclerosis (RMS). Under the terms of the manufacturing supply agreement, FUJIFILM Diosynth Biotechnologies will provide secondary US-based manufacturing supply for BRIUMVI at the Company's new biopharmaceutical manufacturing facility
11/4/24 9:00:00 AM ET
$TGTX
Biotechnology: Pharmaceutical Preparations
Health Care
TG Therapeutics Reports Third Quarter 2024 Financial Results and Raises BRIUMVI® (ublituximab-xiiy) Full Year Revenue Guidance
Third quarter 2024 U.S. BRIUMVI net revenue of $83.3 million Raises full year 2024 U.S. BRIUMVI net revenue target to $300 - $305 million Conference call to be held today, November 4, 2024, at 8:30 AM ET NEW YORK, Nov. 04, 2024 (GLOBE NEWSWIRE) -- TG Therapeutics, Inc. (NASDAQ:TGTX) (the Company or TG Therapeutics) today announced its financial results for the third quarter of 2024, along with recent company developments and provided an update on 2024 revenue guidance. Michael S. Weiss, the Company's Chairman and Chief Executive Officer stated, "The positive feedback and uptake of BRIUMVI in the marketplace continues to outpace our expectations and we are excited to
11/4/24 7:00:00 AM ET
$TGTX
Biotechnology: Pharmaceutical Preparations
Health Care

TG Therapeutics Reports Third Quarter 2024 Financial Results and Raises BRIUMVI® (ublituximab-xiiy) Full Year Revenue Guidance
Third quarter 2024 U.S. BRIUMVI net revenue of $83.3 million Raises full year 2024 U.S. BRIUMVI net revenue target to $300 - $305 million Conference call to be held today, November 4, 2024, at 8:30 AM ET NEW YORK, Nov. 04, 2024 (GLOBE NEWSWIRE) -- TG Therapeutics, Inc. (NASDAQ:TGTX) (the Company or TG Therapeutics) today announced its financial results for the third quarter of 2024, along with recent company developments and provided an update on 2024 revenue guidance. Michael S. Weiss, the Company's Chairman and Chief Executive Officer stated, "The positive feedback and uptake of BRIUMVI in the marketplace continues to outpace our expectations and we are excited to
11/4/24 7:00:00 AM ET
$TGTX
Biotechnology: Pharmaceutical Preparations
Health Care
TG Therapeutics to Host Conference Call on Third Quarter 2024 Financial Results and Business Update
NEW YORK, Nov. 01, 2024 (GLOBE NEWSWIRE) -- TG Therapeutics, Inc. (NASDAQ:TGTX), today announced that a conference call will be held, Monday November 4, 2024, at 8:30 AM ET to discuss results for the third quarter of 2024 and provide a business outlook for the remainder of the year. 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
11/1/24 8:06:02 AM ET
$TGTX
Biotechnology: Pharmaceutical Preparations
Health Care
TG Therapeutics Reports Second Quarter 2024 Financial Results and Raises BRIUMVI® (ublituximab-xiiy) Full Year Revenue Guidance
Second quarter 2024 U.S. BRIUMVI net revenue of $72.6 million Raising full year 2024 U.S. BRIUMVI net revenue target to approximately $290 - $300 million Cash flow positive for second quarter 2024 Establishes $250 million credit facility to repay existing debt and to buy back up to $100 million of common stock under a share repurchase program Initiated phase 1 study in RMS patients for subcutaneous ublituximab and received FDA IND clearance to study azer-cel (allogeneic CD19 CAR-T) in patients with progressive MS Conference call to be held today, August 6, 2024, at 8:30 AM ET NEW YORK, Aug. 06, 2024 (GLOBE NEWSWIRE) -- TG Therapeutics, Inc. (NASDAQ:TGTX) (the Company or TG Therape
8/6/24 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

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Recent Analyst Ratings for $TGTX

$TGTX SEC Filings

SEC Form 10-Q filed by TG Therapeutics Inc.

TG Therapeutics Inc. filed SEC Form 8-K: Results of Operations and Financial Condition, Financial Statements and Exhibits

SEC Form 10-Q filed by TG Therapeutics Inc.

$TGTX Market Insights

Live Market Insights

$1000 Invested In TG Therapeutics 5 Years Ago Would Be Worth This Much Today

(TGTX) - Analyzing TG Therapeutics's Short Interest

TG Therapeutics Discloses Presentations For Post-marketing Studies Being Undertaken For BRIUMVI (ublituximab-xiiy) In Patients With Relapsing Forms Of Multiple Sclerosis At 2024 Consortium Of Multiple Sclerosis Centers Annual Meeting

$TGTX Insider Trading

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

Director Lonial Sagar sold $152,200 worth of shares (5,000 units at $30.44), decreasing direct ownership by 5% to 100,195 units (SEC Form 4)

Director Charney Laurence N sold $754,875 worth of shares (25,000 units at $30.20) and gifted 5,000 shares, decreasing direct ownership by 13% to 207,479 units (SEC Form 4)

Director Echelard Yann sold $489,600 worth of shares (20,000 units at $24.48), decreasing direct ownership by 8% to 224,098 units (SEC Form 4)

$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

FDA Approval for UKONIQ

$TGTX Press Releases

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TG Therapeutics Ranked Number One Fastest-Growing Company in North America on the 2024 Deloitte Technology Fast 500™

FUJIFILM Diosynth Biotechnologies Signs Manufacturing Supply Agreement with TG Therapeutics

TG Therapeutics Reports Third Quarter 2024 Financial Results and Raises BRIUMVI® (ublituximab-xiiy) Full Year Revenue Guidance

$TGTX Financials

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$TGTX Leadership Updates

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$TGTX Large Ownership Changes

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TG Therapeutics Reports Third Quarter 2024 Financial Results and Raises BRIUMVI® (ublituximab-xiiy) Full Year Revenue Guidance

TG Therapeutics to Host Conference Call on Third Quarter 2024 Financial Results and Business Update

TG Therapeutics Reports Second Quarter 2024 Financial Results and Raises BRIUMVI® (ublituximab-xiiy) Full Year Revenue Guidance

Palantir Technologies, Dell Technologies, and Erie Indemnity Set to Join S&P 500; Others to Join S&P MidCap 400 and S&P SmallCap 600

Amendment: SEC Form SC 13G/A filed by TG Therapeutics Inc.

SEC Form SC 13G/A filed by TG Therapeutics Inc. (Amendment)

SEC Form SC 13G/A filed by TG Therapeutics Inc. (Amendment)

$TGTX Analyst Ratings

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

TG Therapeutics upgraded by Goldman with a new price target

Jefferies resumed coverage on TG Therapeutics with a new price target

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