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.

Does TG Therapeutics (TGTX) have what it takes to be a top stock pick for momentum investors? Let's find out.

Are You Looking for a Top Momentum Pick? Why TG Therapeutics (TGTX) is a Great Choice

TG Therapeutics (TGTX) has been upgraded to a Zacks Rank #2 (Buy), reflecting growing optimism about the company's earnings prospects. This might drive the stock higher in the near term.

TG Therapeutics (TGTX) Moves to Buy: Rationale Behind the Upgrade

NEW YORK, July  08, 2020  (GLOBE NEWSWIRE) -- TG Therapeutics, Inc. (NASDAQ: TGTX) today announced the publication of preclinical data describing the unique immunomodulatory effects of umbralisib, the Company’s investigational oral once-daily dual inhibitor of PI3K-delta and CK1-epsilon, in Blood Advances , a Journal of the American Society of Hematology.

TG Therapeutics Announces Publication in Blood Advances Describing Unique Immunomodulatory Effects on CLL T cells by Umbralisib

NEW YORK, June  17, 2020  (GLOBE NEWSWIRE) -- TG Therapeutics, Inc. (NASDAQ: TGTX), a biopharmaceutical company developing medicines for patients with B-cell mediated diseases, today announced the completion of the rolling submission of a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) requesting accelerated approval of 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) and follicular lymphoma (FL). The FDA previously granted umbralisib breakthrough therapy designation (BTD) for MZL and orphan drug designation (ODD) for MZL and FL.

TG Therapeutics Completes Rolling Submission of New Drug Application to the U.S. Food and Drug Administration for Umbralisib as a Treatment for Patients with Previously Treated Marginal Zone Lymphoma or Follicular Lymphoma

Presentation scheduled for Thursday, June 18, 2020, at 3:40 PM ET Presentation scheduled for Thursday, June 18, 2020, at 3:40 PM ET

TG Therapeutics to Present at the Raymond James 2020 Human Health Innovation Conference

NEW YORK, June  12, 2020  (GLOBE NEWSWIRE) -- TG Therapeutics, Inc. (NASDAQ: TGTX), today announced data presentations at the 25th European Hematology Association (EHA) annual congress including data from a Phase 1 study evaluating TG-1701, the Company’s once daily, selective, BTK inhibitor, as monotherapy and in combination with umbralisib and ublituximab (U2) in relapsed/refractory chronic lymphocytic leukemia (CLL) and lymphoma, as well as long term data from a Phase 1/1b study evaluating the combination of umbralisib and ibrutinib in relapsed/refractory CLL and mantle cell lymphoma (MCL).   

TG Therapeutics Announces Data Presentations at the 25th European Hematology Association (EHA) Annual Congress

The development-stage company appears to be on the path to commercial operations.

Here's Why TG Therapeutics Jumped 58.6% in May

Presentation scheduled for, Thursday, June 11, 2020, at 4:40 PM ET Presentation scheduled for, Thursday, June 11, 2020, at 4:40 PM ET

TG Therapeutics to Present at the Goldman Sachs 41st Annual Global Healthcare Conference

The addition of ublituximab to ibrutinib significantly improved PFS, ORR, CR rate, and increased rates of uMRD compared with ibrutinib monotherapy

TG Therapeutics Announces Final Results of the GENUINE Phase 3 Study Evaluating Ublituximab plus Ibrutinib in Previously Treated High-Risk Chronic Lymphocytic Leukemia at the 56th American Society of Clinical Oncology Annual Meeting

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NEW YORK, May  14, 2020  (GLOBE NEWSWIRE) -- TG Therapeutics, Inc. (NASDAQ: TGTX), today announced the schedule of upcoming data presentations at the 56th American Society of Clinical Oncology (ASCO) annual meeting, to be held virtually May 29 – June 1, 2020 and the 25th European Hematology Association (EHA) annual congress, to be held virtually June 11 – 14, 2020. Details of the data presentations are included below.

TG Therapeutics Announces Data Presentations at Upcoming Medical Meetings

NEW YORK, May  08, 2020  (GLOBE NEWSWIRE) -- TG Therapeutics, Inc. (NASDAQ: TGTX), today announced that Owen A. O’Connor, MD, PhD, has joined the Company as Chief Scientific Officer. Dr. O’Connor brings extensive scientific experience in developing drug candidates in oncology and hematology, and most recently served as a Professor of Medicine and Experimental Therapeutics, the Director of the Center for Lymphoid Malignancies, and Co-Program Director of the Lymphoid Development and Malignancy Program in the Herbert Irving Comprehensive Cancer Center at Columbia University Medical Center.

TG Therapeutics Strengthens Executive Team with the Addition of Owen A. O’Connor, MD, PhD, as Chief Scientific Officer

$40 million of which came from longtime shareholder, RA Capital Management $40 million of which came from longtime shareholder, RA Capital Management

TG Therapeutics Raises Approximately $60 Million in Gross Proceeds Through its At-the-Market Facility

Ublituximab was generally well tolerated across all cohorts including those patients receiving one-hour infusions for the 450mg dose currently being studied in the Phase 3 ULTIMATE MS program

TG Therapeutics Announces Publication of Ublituximab Phase 2 Clinical Trial Results in Multiple Sclerosis Journal

NEW YORK, April  29, 2020  (GLOBE NEWSWIRE) -- TG Therapeutics, Inc. (NASDAQ: TGTX), today announced the appointment of Sagar Lonial, MD, FACP, to the Company’s Board of Directors. Dr. Lonial has extensive experience in multiple myeloma and lymphoma treatment and research, and most recently has focused on developing combinations of novel agents for B-cell malignancies, particularly evaluating combinations that may result in synergistic inhibition of the PI3K/Akt pathway. He currently serves as Professor and Chair of the Department of Hematology and Medical Oncology at the Emory University School of Medicine, as well as the Chief Medical Officer at Winship Cancer Institute of Emory University.

TG Therapeutics Bolsters Board of Directors with the Appointment of Sagar Lonial, MD

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TG Therapeutics: 2020 Offers Investors A Cascade Of Clinical And Regulatory Catalysts

NEW YORK, March  05, 2020  (GLOBE NEWSWIRE) -- TG Therapeutics, Inc. (NASDAQ: TGTX) today announced that the U.S. Food and Drug Administration (FDA) granted orphan drug designation to umbralisib, the Company’s investigational dual inhibitor of PI3K-delta and CK1-epsilon, for the treatment of patients with follicular lymphoma (FL).

TG Therapeutics Receives Orphan Drug Designation for Umbralisib from the U.S. Food and Drug Administration for the Treatment of Follicular Lymphoma

TG Therapeutics, Inc. (TGTX) CEO Michael Weiss on Q4 2019 Results - Earnings Call Transcript

TG Therapeutics: More Catalysts Unlocking

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TG received guidance from the FDA allowing submission of a single NDA for Marginal Zone Lymphoma (MZL) and Follicular Lymphoma indications

TG Therapeutics Initiates Rolling Submission of New Drug Application (NDA) to U.S. Food and Drug Administration for Umbralisib as a Treatment for Patients with Previously Treated Marginal Zone Lymphoma or Follicular Lymphoma

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News for TG Therapeutics Stock (TGTX)