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.

Prescription Drug User Fee Act (PDUFA) goal date of March 25, 2022 Prescription Drug User Fee Act (PDUFA) goal date of March 25, 2022

TG Therapeutics Announces FDA Acceptance of Biologics License Application for Ublituximab in Combination with UKONIQ® (umbralisib) as a Treatment for Patients with Chronic Lymphocytic Leukemia and Small Lymphocytic Lymphoma

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TG Therapeutics' (TGTX) CEO Mike Weiss on Q1 2021 Results - Earnings Call Transcript

TG Therapeutics (TGTX) delivered earnings and revenue surprises of -32.69% and -20.14%, respectively, for the quarter ended March 2021. Do the numbers hold clues to what lies ahead for the stock?

TG Therapeutics (TGTX) Reports Q1 Loss, Lags Revenue Estimates

Shares of TG Therapeutics (NASDAQ:TGTX) remained unaffected after the company reported Q1 results. Quarterly Results Earnings per share were down 43.75% year over year to ($0.69), which missed the estimate of ($0.49).

Recap: TG Therapeutics Q1 Earnings

Conference call to be held today, Monday, May 10, 2021 at 8:30 AM ET Conference call to be held today, Monday, May 10, 2021 at 8:30 AM ET

TG Therapeutics Provides Business Update and Reports First Quarter 2021 Financial Results

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The sector's Q1 results are likely to reflect solid earnings and revenue growth on strong base business recovery.

Medical Product Stock Q1 Earnings on May 10: MRVI, TGTX & More

TG Therapeutics (TGTX) doesn't possess the right combination of the two key ingredients for a likely earnings beat in its upcoming report. Get prepared with the key expectations.

Earnings Preview: TG Therapeutics (TGTX) Q1 Earnings Expected to Decline

Fireside chat scheduled for Wednesday, April 28, 2021 at 9:00 AM ET Fireside chat scheduled for Wednesday, April 28, 2021 at 9:00 AM ET

TG Therapeutics to Participate in the B. Riley Securities Neuroscience Conference

ULTRA-V Phase 2 trial has reached completion of patient enrollment ULTRA-V Phase 2 trial has reached completion of patient enrollment

TG Therapeutics Announces Launch of the ULTRA-V Phase 3 Trial Evaluating the Triple Combination of UKONIQ™ (umbralisib), Ublituximab, and Venetoclax

The lead drug umbralisib recently gained FDA approval to treat resistant follicular lymphoma and marginal zone lymphoma. The combination (umbralisib and ublituximab) is poised to secure FDA approval for chronic lymphocytic leukemia.

TG Therapeutics: Hidden Value In Multiple Sclerosis

Ublituximab demonstrated superiority versus teriflunomide in reducing annualized relapse rates and MRI brain lesions

TG Therapeutics Announces Positive Results from the ULTIMATE I & II Phase 3 Trials of Ublituximab in Multiple Sclerosis to be Presented at American Academy of Neurology 73rd Annual Meeting

Webcast to be held tomorrow, April 16, 2021 at 8:30 AM ET Webcast to be held tomorrow, April 16, 2021 at 8:30 AM ET

TG Therapeutics to Host Investor & Analyst Event to Preview Results from the ULTIMATE I & II Phase 3 Trials of Ublituximab in Multiple Sclerosis

NEW YORK, March 29, 2021 (GLOBE NEWSWIRE) -- TG Therapeutics, Inc. (NASDAQ: TGTX), today announced the completion of the rolling submission of a Biologics License Application (BLA) to the U.S. Food and Drug Administration (FDA) requesting approval of ublituximab, the Company's investigational glycoengineered anti-CD20 monoclonal antibody, in combination with UKONIQTM (umbralisib) , the Company's once-daily, oral, inhibitor of PI3K-delta and CK1-epsilon, as a treatment for patients with chronic lymphocytic leukemia (CLL). The U.S. FDA previously granted Fast Track designation to the combination of ublituximab and umbralisib (U2) for the treatment of adult patients with CLL and orphan drug designation for ublituximab in combination with umbralisib for the treatment of CLL. The BLA submission was based on the results of the UNITY-CLL trial, a global Phase 3 trial evaluating the combination of umbralisib plus ublituximab (U2) compared to obinutuzumab plus chlorambucil in patients with previously untreated and relapsed/refractory chronic lymphocytic leukemia (CLL).

TG Therapeutics Completes Rolling Submission of Biologics License Application to the U.S. Food and Drug Administration for Ublituximab in Combination with UKONIQ™(umbralisib) as a Treatment for Patients with Chronic Lymphocytic Leukemia

TG Therapeutics (TGTX) was a big mover last session on higher-than-average trading volume. The latest trend in earnings estimate revisions might help the stock continue moving higher in the near term.

Strength Seen in TG Therapeutics (TGTX): Can Its 6.7% Jump Turn into More Strength?

NEW YORK, March 09, 2021 (GLOBE NEWSWIRE) -- TG Therapeutics, Inc. (NASDAQ: TGTX) today announced the publication of results from the UNITY-NHL Phase 2b trial evaluating UKONIQ™ (umbralisib), the Company's inhibitor of PI3k-delta and CK1-epsilon, in patients with relapsed or refractory indolent non-Hodgkin Lymphoma (NHL) in the Journal of Clinical Oncology (JCO).

TG Therapeutics Announces Publication of Results from the UNITY-NHL Phase 2b Trial Evaluating Umbralisib Monotherapy in Patients with Relapsed or Refractory Indolent non-Hodgkin Lymphoma in the Journal of Clinical Oncology

We did well with TGTX earlier, and the stock is again in the buy zone. There are a number of major catalysts and approvals in the next 12 months.

TG Therapeutics: Great Set Of Catalysts, Approvals This Year And Next

NEW YORK, March 04, 2021 (GLOBE NEWSWIRE) -- TG Therapeutics, Inc. (NASDAQ: TGTX), today announced that results of the ULTIMATE I & II Phase 3 trials evaluating ublituximab, the Company's novel, glycoengineered anti-CD20 monoclonal antibody, in relapsing forms of multiple sclerosis (RMS) have been selected for presentation at the upcoming American Academy of Neurology (AAN) annual meeting, being held virtually April 17 – 22, 2021. The abstract is available online and can be accessed via the below link or on the AAN meeting website at www.aan.com.

TG Therapeutics to Present Results from the ULTIMATE I & II Phase 3 Trials Evaluating Ublituximab in Multiple Sclerosis at the Upcoming American Academy of Neurology 73rd Annual Meeting

TG Therapeutics' (TGTX) CEO Michael Weiss on Q4 2020 Results - Earnings Call Transcript

Conference call to be held Tuesday, March 2, 2021 at 8:30 AM ET Conference call to be held Tuesday, March 2, 2021 at 8:30 AM ET

TG Therapeutics to Host Conference Call on Fourth Quarter and Year-End 2020 Financial Results and Business Update

NEW YORK, Feb. 23, 2021 (GLOBE NEWSWIRE) -- TG Therapeutics, Inc. (NASDAQ: TGTX) today announced the publication of final results from the Phase 3 GENUINE trial evaluating ublituximab, the Company's investigational glycoengineered anti-CD20 monoclonal antibody, in combination with ibrutinib, in patients with relapsed or refractory high-risk chronic lymphocytic leukemia (CLL), in The Lancet Haematology.

TG Therapeutics Announces Publication of Final Results from the Phase 3 GENUINE Trial Evaluating Ublituximab Plus Ibrutinib in Patients with Relapsed/Refractory High-Risk Chronic Lymphocytic Leukemia in The Lancet Haematology

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UKONIQ is approved for adult patients with relapsed or refractory marginal zone lymphoma after at least one prior anti-CD20 based regimen

TG Therapeutics Announces FDA Accelerated Approval of UKONIQ™ (umbralisib)

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

News for TG Therapeutics Stock (TGTX)