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.

NEW YORK--(BUSINESS WIRE)--WHY: Rosen Law Firm, a global investor rights law firm, announces the filing of a class action lawsuit on behalf of purchasers of the securities of TG Therapeutics, Inc. (NASDAQ: TGTX) between January 15, 2020 and May 31, 2022, both dates inclusive (the “Class Period”). If you wish to serve as lead plaintiff, you must move the Court no later than September 16, 2022. SO WHAT: If you purchased TG Therapeutics securities you may be entitled to compensation without paymen

EQUITY ALERT: Rosen Law Firm Encourages TG Therapeutics, Inc. Investors with Losses in Excess of $100K to Secure Counsel Before Important Deadline in Securities Class Action – TGTX

Ublituximab used to be TGTX's second asset and a very large potential icing on the cake for the company. After umbralisib went down, ubli has become its lifeline.

TG Therapeutics And Ublituximab: From Icing To Lifeline

NEW YORK , June 27, 2022 /PRNewswire/ -- Pomerantz LLP is investigating claims on behalf of investors of  TG Therapeutics, Inc. ("TG Therapeutics" or the "Company") (NASDAQ: TGTX).  Such investors are advised to contact Robert S.

SHAREHOLDER ALERT: Pomerantz Law Firm Investigates Claims On Behalf of Investors TG Therapeutics, Inc. - TGTX

NEW YORK, June 27, 2022 (GLOBE NEWSWIRE) -- TG Therapeutics, Inc. (NASDAQ: TGTX), today announced data presentations highlighting data from pooled and post hoc analyses of the ULTIMATE I & II Phase 3 trials evaluating ublituximab in patients with relapsing forms of multiple sclerosis (RMS), presented at the 8th Congress of the European Academy of Neurology (EAN). Links to the presentations are included below.

TG Therapeutics Announces Presentation of Exploratory Analyses from the ULTIMATE I & II Phase 3 Trials of Ublituximab in Multiple Sclerosis at the 8Th Congress of the European Academy of Neurology

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.

TG Therapeutics (TGTX) Soars 18.7%: Is Further Upside Left in the Stock?

NEW YORK, June 03, 2022 (GLOBE NEWSWIRE) -- TG Therapeutics, Inc. (NASDAQ: TGTX), today announced data presentations, including one oral and two poster presentations, highlighting data from exploratory and pooled analyses from the ULTIMATE I & II Phase 3 trials evaluating ublituximab in patients with relapsing forms of multiple sclerosis (RMS), presented at the Consortium of Multiple Sclerosis Centers (CMSC) annual meeting. Links to the presentations are included below.

TG Therapeutics Announces Presentation of Exploratory Analyses from the ULTIMATE I & II Phase 3 Trials of Ublituximab in Multiple Sclerosis at the 2022 Consortium of Multiple Sclerosis Centers Annual Meeting

The FDA extends PDUFA date by three months on TG Therapeutics' (TGTX) regulatory submission for ublituximab for relapsing multiple sclerosis. Shares fell 14.5% following the announcement.

FDA Delays Decision on TGTX's BLA for Multiple Sclerosis Drug

New PDUFA goal date of December 28, 2022 New PDUFA goal date of December 28, 2022

TG Therapeutics Announces FDA Extension of BLA PDUFA Date for Ublituximab to Treat Patients with RMS

NEW YORK, May 26, 2022 (GLOBE NEWSWIRE) -- TG Therapeutics, Inc. (NASDAQ: TGTX), today announced the schedule of data presentations, including one oral and two poster presentations, highlighting data from the ULTIMATE I & II Phase 3 trials evaluating ublituximab in patients with relapsing forms of multiple sclerosis (RMS), at the upcoming Consortium of Multiple Sclerosis Centers (CMSC) annual meeting, being held June 1-4, 2022, in National Harbor, Maryland. Abstracts are now available online and can be accessed on the International Journal of MS Care (IJMSC) website at www.ijmsc.org , or by following this direct link https://doi.org/10.7224/1537-2073-24.s1.1 . Details of the presentations are outlined below. Michael S. Weiss, Chairman and Chief Executive Officer of TG Therapeutics stated, “We are excited to be presenting three data sets from the ULTIMATE I & II Phase 3 trials at the 2022 CMSC annual meeting next week, including an oral presentation highlighting reduced disease progression with ublituximab compared to teriflunomide in patients with RMS.” Mr. Weiss continued, “We look forward to next week's meeting and to sharing these additional data.”

TG Therapeutics Announces Data Presentations from the ULTIMATE I & II Phase 3 Trials of Ublituximab in Multiple Sclerosis to be Presented at the 2022 Consortium of Multiple Sclerosis Centers Annual Meeting

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Presentation available for on demand download beginning Tuesday May 24, 2022 at 7:00 AM ET Presentation available for on demand download beginning Tuesday May 24, 2022 at 7:00 AM ET

TG Therapeutics to Participate in the H.C. Wainwright Global Investment Conference

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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.

Will TG Therapeutics (TGTX) Report Negative Q1 Earnings? What You Should Know

Fireside chat scheduled for Thursday, April 28, 2022 at 12:30 PM ET Fireside chat scheduled for Thursday, April 28, 2022 at 12:30 PM ET

TG Therapeutics to Participate in the B. Riley Securities' 2022 Virtual Neuro & Ophthalmology Conference

Whenever volatility is due to the larger market condition (says, a bear market), your stock will most likely rebound to surpass their former high. After it received a partial clinical hold, TG Therapeutics now encounters more problems than what I anticipated.

TG Therapeutics: Can The Company Successfully Turn Around?

TG Therapeutics (TGTX) voluntarily withdraws regulatory application seeking approval for the combination regimen, ublituximab plus Ukoniq. It also withdraws Ukoniq from sale in approved indications.

TG Therapeutics (TGTX) Withdraws FDA Submission, Stock Down

TG Therapeutics Inc's (NASDAQ: TGTX) shares are plunging after new data showed that ublituximab /Ukoniq showed an elevated risk of death in the phase 3 Unity combo trial for chronic lymphocytic leukemia (CLL) and small lymphocytic lymphoma (SLL) HC Wainwright has slashed the.

Despite Price Cut, HC Wainwright Keeps Buy Rating On TG Therapeutics - Read Why

TGTX withdrew its BLA/NDA for CLL due to OS complications. The stock may be hit hard on Monday.

TG Therapeutics: I May Double Down Again

Shares of TG Therapeutics Inc. TGTX, -21.85% tumbled 24.2% in trading on Monday following the company's announcement on Friday that it had withdrawn an application to get Food and Drug Administration approval for ublituximab and Ukoniq as a treatment for chronic lymphocytic leukemia and small lymphocytic lymphoma. TG said in a news release that it decided to withdraw the application due to updated survival data from a Phase 3 clinical trial.

TG Therapeutics to pull FDA submission for oncology drug; shares slid 24%

TG Therapeutics Inc (NASDAQ: TGTX) shares are trading significantly lower Monday morning after the company announced it has voluntarily withdrawn the pending Biologics License Application/supplemental New Drug Application for the combination of ublituximab and UKONIQ for the.

Why TG Therapeutics Stock Is Plunging Today

TG Therapeutics Inc's (NASDAQ: TGTX) new data showed that ublituximab /Ukoniq, dubbed U2, had an elevated risk of death in the phase 3 Unity combo trial or chronic lymphocytic leukemia (CLL) and small lymphocytic lymphoma (SLL) The data analyzed at the request of the FDA showed.

TG Therapeutics Retracts FDA Request For Ublituximab / Ukoniq Combo In Blood Cancers

Company voluntarily withdraws UKONIQ ® from sale for approved indications of relapsed/refractory MZL and FL Company to host conference call, Monday, April 18, 2022 at 8:30 AM ET NEW YORK, April 15, 2022 (GLOBE NEWSWIRE) -- TG Therapeutics, Inc. (NASDAQ: TGTX), today announced that the Company has voluntarily withdrawn the pending Biologics License Application (BLA)/supplemental New Drug Application (sNDA) for the combination of ublituximab and UKONIQ® (umbralisib) (combination referred to as U2) for the treatment of adult patients with chronic lymphocytic leukemia (CLL) and small lymphocytic lymphoma (SLL). The decision to withdraw was based on recently updated overall survival (OS) data from the UNITY-CLL Phase 3 trial that showed an increasing imbalance in OS. Additional details are included below in the section entitled “ABOUT UNITY-CLL PHASE 3 TRIAL AND THE WITHDRAWAL OF THE BLA/sNDA SUBMISSION.”

TG Therapeutics Announces Voluntary Withdrawal of the BLA/sNDA for U2 to Treat Patients with CLL and SLL

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NEW YORK, April 06, 2022 (GLOBE NEWSWIRE) -- TG Therapeutics, Inc. (NASDAQ: TGTX), today announced that data from the ULTIMATE I & II Phase 3 trials evaluating ublituximab in patients with relapsing forms of multiple sclerosis (RMS), were presented yesterday during an oral session at the American Academy of Neurology (AAN) annual meeting, held in Seattle, Washington. Highlights of the presentation are outlined below.

TG Therapeutics Announces Oral Presentation of Data from the ULTIMATE I & II Phase 3 Trials of Ublituximab in Multiple Sclerosis at the American Academy of Neurology Annual Meeting

NEW YORK, April 04, 2022 (GLOBE NEWSWIRE) -- TG Therapeutics, Inc. (NASDAQ: TGTX), today announced data from the ULTIMATE I & II Phase 3 trials evaluating ublituximab in patients with relapsing forms of multiple sclerosis (RMS), presented over the weekend at the American Academy of Neurology (AAN) annual meeting, held in Seattle, Washington. Highlights of the presentations are outlined below.

TG Therapeutics Announces Data Presentations from the ULTIMATE I & II Phase 3 Trials of Ublituximab in Multiple Sclerosis Presented at the American Academy of Neurology Annual Meeting

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