TG Therapeutics

TG Therapeutics, Inc. engages in the acquisition, development, and commercialization of novel treatments for B-cell malignancies and autoimmune diseases. Its product pipeline includes TG-1501, TG-1701, Ublituximab, and Umbralisib. The company was founded by Michael Sean Weiss and Laurence H. Shaw on May 18, 1993 and is headquartered in New York, NY.

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TG Therapeutics secures FDA approval for BRIUMVI, poised for growth

TG Therapeutics' Q4 2022 performance reflects a solid financial position with a focus on efficient capital management and commercial execution.
Strengths lie in FDA approval for BRIUMVI, positive launch progress, and commitment to supporting the MS community, positioning the company for growth.
Challenges include sustaining momentum, achieving broad payer coverage, managing expenses, and navigating complexities related to clinical trials.
Opportunities exist in further data analysis, market expansion, community engagement, and strategic investments, driving future growth and differentiation.

TG Therapeutics excels with BRIUMVI launch, eyes European expansion

TG Therapeutics demonstrated strong financial stability and strategic expense management in Q1 2023, despite reporting a net loss, showcasing resilience and efficient operations.
BRIUMVI's early success in the US market, positive feedback from healthcare providers, and progress in payer coverage position the product as a competitive and promising offering in the MS treatment class.
While facing decisions on international expansion and expense optimization, TG Therapeutics remains committed to serving the MS community and improving patient outcomes with BRIUMVI.
The company's focus on market access, product efficacy, and financial prudence sets a solid foundation for future growth and success in the competitive pharmaceutical landscape.

TG Therapeutics reports stellar Q2 performance and eyes global expansion

TG Therapeutics showcased robust financial performance and market acceptance of Briumvi in Q2 2023.
While facing challenges like revenue lag and potential market competition, the company remains well-positioned.
Opportunities lie in expanding market reach, product offerings, and maximizing the potential of Briumvi.
Overall, TG Therapeutics' strategic partnerships and positive market feedback position it for continued success.

TG Therapeutics excels in Q3 with BRIUMVI's market success

TG Therapeutics had a strong Q3 performance, driven by BRIUMVI's success and revenue exceeding expectations. The company is well-positioned with a healthy cash reserve and plans for market expansion. Challenges include potential competition from BTK drugs and seasonal market fluctuations.

TG Therapeutics excels in Q4 with BRIUMVI, eyes strong growth

TG Therapeutics demonstrated robust financial performance and strategic growth plans during the Q4 2023 earnings call, driven by the successful launch of BRIUMVI.
While facing challenges such as optimizing the infusion process and managing expenses, the company's focus on innovation and market expansion positions it for future success.
With a strong emphasis on commercialization, patent protection, and revenue targets, TG Therapeutics shows promising potential for sustained growth and value creation.

TG Therapeutics reports robust Q1 results, eyes growth opportunities

TG Therapeutics' Q1 performance reflects strong revenue growth driven by Briumvi's success and strategic investments in awareness and commercialization.
While facing challenges in market share growth and profitability, the company's focus on innovation and partnerships positions it well for future opportunities.
Maintaining a healthy financial position and a commitment to R&D underscore TG Therapeutics' resilience and potential for continued growth in the autoimmune therapy space.

TG Therapeutics excels in Q2, raises guidance and focuses on growth

TG Therapeutics delivered a strong Q2 performance with notable achievements in sales, R&D, and financial stability. While facing challenges related to internal controls and VA contract impact, the company is well-positioned to capitalize on opportunities for growth through market expansion and strategic initiatives.

TG Therapeutics reports robust Q3 earnings and outlines growth strategies

TG Therapeutics (TGTX) delivered a strong performance in Q3 2024, driven by the success of BRIUMVI and strategic growth initiatives.
While facing challenges in market competition and product development, TGTX remains focused on innovation, expansion, and maximizing shareholder value.
The company's financial strength, successful partnerships, and clear growth strategies position TGTX for continued success and future growth in the biopharmaceutical industry.

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TG Therapeutics, Inc. engages in the acquisition, development, and commercialization of novel treatments for B-cell malignancies and autoimmune diseases. Its product pipeline includes TG-1501, TG-1701, Ublituximab, and Umbralisib. The company was founded by Michael Sean Weiss and Laurence H. Shaw on May 18, 1993 and is headquartered in Morrisville, NC.

Fireside chat scheduled for Wednesday, January 20, 2021 at 10:00 AM ET Fireside chat scheduled for Wednesday, January 20, 2021 at 10:00 AM ET

TG Therapeutics to Participate in the B. Riley Securities Oncology Investor Conference

Presentation scheduled for Tuesday, January 12, 2021 at 2:00 PM ET Presentation scheduled for Tuesday, January 12, 2021 at 2:00 PM ET

TG Therapeutics to Present at the 39th Annual J.P. Morgan Healthcare Conference

After a protracted wait, TG Therapeutics Inc. (NASDAQ:TGTX) shareholders finally got rewarded for their patience last month when the stock began a rapid climb to its current price of $52. That's a gain of nearly 350% in the past year, a bonanza for investors who have owned the stock since late 2011, but only a slight consolation for those who bought in at more than $182 in May 2010.

TG Therapeutics Shares Climb on Study Results

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Investors need to pay close attention to TG Therapeutics (TGTX) stock based on the movements in the options market lately.

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Umbralisib and ublituximab have excellent chances of gaining FDA approval for various blood cancers next year. TGTX also recently reported robust data for ublituximab as a treatment for relapsing multiple sclerosis.

TG Therapeutics: What's Next After The MS Conquest?

NEW YORK, Dec. 14, 2020 (GLOBE NEWSWIRE) -- TG Therapeutics, Inc. (NASDAQ: TGTX), a biopharmaceutical company developing medicines for patients with B-cell mediated diseases (“the Company”), today announced the pricing of an underwritten public offering of 6,320,000 shares of common stock at a public offering price of $43.50 per share. Gross proceeds to the Company from the offering are expected to be approximately $275,000,000 before deducting underwriting discounts and commissions and estimated offering expenses payable by the Company. In addition, the Company has granted the underwriters a 30-day option to purchase up to an additional 948,000 shares of common stock in connection with the offering. All shares are being sold by the Company. The offering is expected to close on December 17, 2020, subject to the satisfaction of customary closing conditions. The offering was upsized from the previously announced offering size of approximately $200,000,000 of common stock.

TG Therapeutics Announces Pricing of Upsized Public Offering of Common Stock

NEW YORK, Dec. 14, 2020 (GLOBE NEWSWIRE) -- TG Therapeutics, Inc. (NASDAQ: TGTX), a biopharmaceutical company dedicated to developing medicines for patients with B-cell mediated diseases (“TG Therapeutics”), today announced that it has commenced an underwritten public offering of $200,000,000 of its common stock. The offering is subject to market and other conditions, and there can be no assurance as to whether or when the offering may be completed, or as to the actual size or terms of the offering. TG Therapeutics intends to grant the underwriters a 30-day option to purchase up to an additional $30,000,000 of its common stock.

TG Therapeutics Announces Proposed Public Offering of Common Stock

TG Therapeutics stock jumped after the biotech firm announced positive top-line results from two phase 3 studies for its Ublituximab treatment of multiple sclerosis patients. The post TG Therapeutics Stock Jumps On Positive Results For Multiple Sclerosis Treatment appeared first on Investor's Business Daily.

TG Therapeutics Stock Jumps On Positive Results For Multiple Sclerosis Treatment

Both studies met their primary endpoint of significantly reducing annualized relapse rate ( ARR ) (p

TG Therapeutics Announces Positive Topline Results from the ULTIMATE I & II Phase 3 Studies Evaluating Ublituximab Monotherapy for the Treatment of Patients with Multiple Sclerosis

Corning

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Lam Research

Lee Ainslie (Trades, Portfolio), the founder and CEO of Maverick Capital, recently disclosed the firm's portfolio changes for the third quarter of 2020, which ended on Sept. 30.

Top 3rd-Quarter Buys of Lee Ainslie's Maverick Capital

UNITY-CLL: U2 significantly improved progression-free survival over obin utuz u mab plus chlorambucil (HR= 0 .54, p

TG Therapeutics Announces Pivotal Data from the UNITY-CLL and UNITY-NHL Clinical Trials Presented at the 62nd American Society of Hematology Annual Meeting

U2 + Venetoclax: 100% ORR at cycle 12 (n=27), including 41% CR rate, and 96% of patients achieving undetectable MRD in the peripheral blood and 77% achieving undetectable MRD in bone marrow

TG Therapeutics Announces Triple Combination Data Presentations at the at the 62nd American Society of Hematology Annual Meeting

Since last year, TGTX has executed its programs brilliantly. Cash position also is decent, although I expect some justified dilution before revenue generation.

TG Therapeutics: Excellent, Multi-Modal Opportunity

NEW YORK, Dec. 02, 2020 (GLOBE NEWSWIRE) -- TG Therapeutics, Inc. (NASDAQ: TGTX) today announced the publication of data from a Phase 2 study evaluating umbralisib, the Company's investigational once daily, oral, dual inhibitor of PI3K-delta and CK1-epsilon, in patients with chronic lymphocytic leukemia (CLL) who are intolerant to prior BTK or PI3K-delta inhibitor therapy, in Blood, the Journal of the American Society of Hematology.

TG Therapeutics Announces Publication of Phase 2 Data Evaluating Umbralisib in Patients with Chronic Lymphocytic Leukemia Who Are Intolerant to Prior BTK or PI3K Inhibitor Therapy in Blood

Fireside chat scheduled for Tuesday, December 1, 2020 at 10:05 AM ET Fireside chat scheduled for Tuesday, December 1, 2020 at 10:05 AM ET

TG Therapeutics to Participate in the 3rd Annual Evercore ISI HealthCONx Conference

Fireside chat scheduled for Tuesday, November 17, 2020 at 2:20 PM ET/ 7:20 PM GMT Fireside chat scheduled for Tuesday, November 17, 2020 at 2:20 PM ET/ 7:20 PM GMT

TG Therapeutics to Participate in the Jefferies Virtual London Healthcare Conference

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Was The Smart Money Right About Loading Up On TG Therapeutics Inc (TGTX)?

NEW YORK, Nov. 09, 2020 (GLOBE NEWSWIRE) -- TG Therapeutics, Inc. (NASDAQ: TGTX) today announced its financial results for the third quarter ended September 30, 2020 and recent company developments.

TG Therapeutics Provides Business Update and Reports Third Quarter 2020 Financial Results

UNITY-CLL: U2 significantly improved progression-free survival over obinutuzimab plus chlorambucil (HR= 0 .54, p

TG Therapeutics Highlights Data Selected for Presentation at the 62nd American Society of Hematology (ASH) Annual Meeting

NEW YORK, Oct. 21, 2020 (GLOBE NEWSWIRE) -- TG Therapeutics, Inc. (NASDAQ: TGTX), today announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track Designation to the combination of ublituximab, the Company's investigational glycoengineered anti-CD20 monoclonal antibody, and umbralisib, the Company's investigational once-daily, oral, dual inhibitor of PI3K-delta and CK1-epsilon, for the treatment of adult patients with chronic lymphocytic leukemia (CLL). Michael S. Weiss, Executive Chairman and Chief Executive Officer of TG Therapeutics stated, "We are extremely pleased to have received Fast Track designation for the ublituximab plus umbralisib regimen, or the U2 combination, to treat adult patients with CLL. The application for Fast Track was based on data from the UNITY-CLL Phase 3 study that we announced earlier this year had met its primary endpoint of progression free survival. This designation holds several important advantages to potentially expedite the development and regulatory review of U2 and underscores the significant unmet medical need that still exists for patients with CLL.” Mr. Weiss continued, “We look forward to presenting data from the UNITY-CLL Phase 3 trial later this year, which we plan to use as the basis of a U2 regulatory submission for CLL.” ABOUT FAST TRACK Fast Track is a program designed to expedite the development and review of drugs that treat serious conditions and that demonstrate the potential to address an unmet medical need. Filling an unmet medical need is defined as providing a therapy where none exists or providing a therapy that may be potentially better than available therapy.  A drug that receives Fast Track designation is eligible for more frequent interactions with the FDA, priority review if relevant criteria are met, and rolling submission of the Biologic License Application or New Drug Application.

TG Therapeutics Announces Fast Track Designation Granted by the FDA to Ublituximab in Combination with Umbralisib for the Treatment of Adult Patients with Chronic Lymphocytic Leukemia

TG Therapeutics (NASDAQ: TGTX) shares are trading higher on Thursday after the company announced that the FDA accepted its new drug application for its Umbralisib as a treatment for patients with the previously-treated marginal zone Lymphoma and Follicular Lymphoma.

Why TG Therapeutics Is Trading Higher Today

NEW YORK, Aug.  13, 2020  (GLOBE NEWSWIRE) -- TG Therapeutics, Inc. (NASDAQ: TGTX), today announced that the U.S. Food and Drug Administration (FDA) has accepted the Company’s New Drug Application (NDA) for umbralisib, the Company’s investigational once-daily, oral, dual inhibitor of PI3K-delta and CK1-epsilon, as a treatment for patients with previously treated marginal zone lymphoma (MZL) who have received at least one prior anti-CD20 based regimen and follicular lymphoma (FL) who have received at least two prior systemic therapies. The MZL indication, under Breakthrough Therapy Designation (BTD), has been accepted for Priority Review and has a Prescription Drug User Fee Act (PDUFA) goal date of February 15, 2021. The FL indication has been accepted for standard review with a PDUFA goal date of June 15, 2021. The FDA also notified the Company that it is not currently planning to hold an advisory committee meeting to discuss this application.

TG Therapeutics Announces FDA Acceptance of New Drug Application for Umbralisib as a Treatment for Patients with Previously Treated Marginal Zone Lymphoma and Follicular Lymphoma

TG Therapeutics (TGTX) CEO, Michael Weiss on Q2 2020 Results - Earnings Call Transcript

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