FDA Approval for BRIUMVI issued to TG THERAPEUTICS, INC

12/28/22 12:54:09 PM ET

$TGTX

Biotechnology: Pharmaceutical Preparations

Health Care

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Biologic License Application (BLA): 761238
Company: TG THERAPEUTICS, INC

Products on BLA 761238

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
BRIUMVI	UBLITUXIMAB	25 MG/ML	INJECTABLE;INTRAVENOUS	Prescription	None	No	No

Approval Date(s) and History, Letters, Labels, Reviews for BLA 761238

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
12/28/2022	ORIG-1	Approval		N/A		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
Financials

Live finance-specific insights

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
TG Therapeutics to Host Conference Call on Second Quarter 2024 Financial Results and Business Update
NEW YORK, Aug. 05, 2024 (GLOBE NEWSWIRE) -- TG Therapeutics, Inc. (NASDAQ:TGTX), today announced that a conference call will be held, Tuesday August 6, 2024 at 8:30 AM ET to discuss results for the second quarter of 2024 and provide a business outlook for 2024. 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 Second Quarter 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
8/5/24 7:30:00 AM ET
$TGTX
Biotechnology: Pharmaceutical Preparations
Health Care

$TGTX
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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
New BRIUMVI® (ublituximab-xiiy) Data from the ENHANCE Phase 3b Study Show Rapid 30-Minute Infusions are Well Tolerated in Patients with Relapsing Forms of Multiple Sclerosis
Infusion related reactions in patients receiving 30-minute BRIUMVI infusions were all mild (Grade 1) and resolved completely Data also demonstrate patients switching from prior anti-CD20 treatment can successfully eliminate initial BRIUMVI infusion NEW YORK, Sept. 18, 2024 (GLOBE NEWSWIRE) -- TG Therapeutics, Inc. (NASDAQ:TGTX), today presented updated data from the ENHANCE Phase 3b trial evaluating BRIUMVI® (ublituximab-xiiy) in patients with relapsing forms of multiple sclerosis (RMS), at the 2024 European Committee for Treatment and Research in Multiple Sclerosis (ECTRIMS) annual meeting. Highlights from the presentation are outlined below. Michael S. Weiss, the Company's Chairman an
9/18/24 7:15:00 AM ET
$TGTX
Biotechnology: Pharmaceutical Preparations
Health Care
New Data for BRIUMVI® (ublituximab-xiiy) Demonstrate that 92% of Patients with Relapsing Multiple Sclerosis Were Free from Disability Progression After 5 Years of Treatment
During year 5 of treatment with BRIUMVI the annualized relapse rate was 0.020, equivalent to one relapse occurring every 50 years of patient treatment Overall safety profile of BRIUMVI remained consistent over 5 years of continuous treatment, with no new safety signals emerging with prolonged treatment NEW YORK, Sept. 18, 2024 (GLOBE NEWSWIRE) -- TG Therapeutics, Inc. (NASDAQ:TGTX), today announced updated data presentations including new five-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 2024 European Committee for Treatment and Research in Multiple Sclerosis (ECTRIMS) annual
9/18/24 7:00:00 AM ET
$TGTX
Biotechnology: Pharmaceutical Preparations
Health Care

FDA Approval for BRIUMVI issued to TG THERAPEUTICS, INC

Products on BLA 761238

Approval Date(s) and History, Letters, Labels, Reviews for BLA 761238

Original Approvals or Tentative Approvals

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Recent Analyst Ratings for $TGTX

$TGTX Insider Trading

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

Director Lonial Sagar sold $432,889 worth of shares (25,933 units at $16.69) and was granted 22,250 shares, decreasing direct ownership by 3% to 105,195 units (SEC Form 4)

Director Hume Daniel was granted 22,250 shares, increasing direct ownership by 10% to 240,489 units (SEC Form 4)

Director Hoberman Kenneth was granted 22,250 shares, increasing direct ownership by 9% to 264,935 units (SEC Form 4)

$TGTX Financials

Live finance-specific insights

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

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

$TGTX Large Ownership Changes

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

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

SEC Form SC 13G filed by TG Therapeutics Inc.

$TGTX Leadership Updates

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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

$TGTX Press Releases

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

New BRIUMVI® (ublituximab-xiiy) Data from the ENHANCE Phase 3b Study Show Rapid 30-Minute Infusions are Well Tolerated in Patients with Relapsing Forms of Multiple Sclerosis

New Data for BRIUMVI® (ublituximab-xiiy) Demonstrate that 92% of Patients with Relapsing Multiple Sclerosis Were Free from Disability Progression After 5 Years of Treatment

$TGTX FDA approvals

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FDA Approval for BRIUMVI issued to TG THERAPEUTICS, INC

FDA Approval for BRIUMVI issued to TG THERAPEUTICS, INC

FDA Approval for UKONIQ

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SEC Form 10-Q filed by TG Therapeutics Inc.

Amendment: SEC Form 10-K/A filed by TG Therapeutics Inc.

TG Therapeutics Inc. filed SEC Form 8-K: Entry into a Material Definitive Agreement, Termination of a Material Definitive Agreement, Results of Operations and Financial Condition, Other Events, Financial Statements and Exhibits

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

$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

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