Welcome to our dedicated page for Tg Therapeutics news (Ticker: TGTX), a resource for investors and traders seeking the latest updates and insights on Tg Therapeutics stock.
TG Therapeutics, Inc. (NASDAQ: TGTX) is a commercial-stage biopharmaceutical company focused on B-cell diseases, with news flow centered on its CD20-targeted monoclonal antibody BRIUMVI (ublituximab-xiiy) for relapsing forms of multiple sclerosis (RMS). This news page aggregates company announcements, clinical data updates, financial results, and corporate presentations related to TGTX stock.
Recent press releases highlight preliminary and reported revenue from BRIUMVI, including disclosures that product revenue consists primarily of net product sales of BRIUMVI in the United States and sales to ex-U.S. partners. Investors can follow updates on revenue guidance, operating expense targets, and commentary on how BRIUMVI commercialization influences overall company performance.
TG Therapeutics also issues frequent news about its development programs. These items include progress in the ENHANCE Phase 3b trial evaluating a simplified intravenous dosing schedule for BRIUMVI, the Phase 3 pivotal program for subcutaneous ublituximab, and the Phase 1 trial of azer-cel, an allogeneic CD19 CAR T therapy in autoimmune disease. Additional releases cover long-term ULTIMATE I & II trial data, real-world ENABLE observational study outcomes, and schedules of data presentations at neurology and multiple sclerosis congresses.
Corporate news includes participation in major healthcare and biotechnology investor conferences, rankings such as the Deloitte Technology Fast 500, and announcements of share repurchase authorizations. By following this TGTX news feed, readers can monitor how clinical results, regulatory milestones, commercialization updates, and financial disclosures intersect for TG Therapeutics and its lead therapy BRIUMVI.
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On April 27, 2023, TG Therapeutics (NASDAQ: TGTX) announced that the U.S. Centers for Medicare & Medicaid Services issued a permanent J-Code for BRIUMVI (ublituximab-xiiy), effective July 1, 2023. The permanent J-Code (J2329) simplifies the claims and reimbursement process for BRIUMVI, enhancing patient access to treatment for relapsing forms of multiple sclerosis (RMS). Michael S. Weiss, CEO, highlighted this milestone as significant for BRIUMVI's early launch phase. While J-Codes are crucial for reimbursement, BRIUMVI's safety profile includes warnings about potential infusion reactions and infections, with serious incidents reported in clinical trials. The company anticipates further updates during its first quarter earnings call.
TG Therapeutics (NASDAQ: TGTX) announced presentations of data from its ULTIMATE I & II Phase 3 trials evaluating BRIUMVI (ublituximab-xiiy) for relapsing forms of multiple sclerosis (RMS) at the American Academy of Neurology annual meeting. CEO Michael S. Weiss expressed satisfaction with the presentation of additional analyses and in-vitro characterizations of BRIUMVI. Key presentations by leading authors included efficacy data in treatment-naive participants and results in those with highly active disease. The trials, which enrolled 1,094 patients across 10 countries, showcased BRIUMVI's design to deplete B-cells efficiently. The company aims to share further exploratory analyses throughout the year, underlining BRIUMVI's potential in treating RMS.
TG Therapeutics (NASDAQ: TGTX) announced that the European Medicines Agency's CHMP recommended approval of BRIUMVI™ (ublituximab-xiiy) for adults with relapsing forms of multiple sclerosis (RMS) with active disease. This follows the FDA's approval in the U.S. in December 2022, making BRIUMVI the first anti-CD20 monoclonal antibody approved for this indication. The recommendation is based on successful outcomes from the ULTIMATE I & II Phase 3 trials, which showed BRIUMVI significantly reduced the annualized relapse rate compared to teriflunomide. A decision by the European Commission is anticipated in about two months.
TG Therapeutics (TGTX) plans to present data from the ULTIMATE I & II Phase 3 trials of BRIUMVI (ublituximab-xiiy) for treating relapsing forms of multiple sclerosis (RMS) at the American Academy of Neurology meeting from April 22-27, 2023. Key presentations include:
- Enhanced ADCC of Ublituximab on April 25.
- Efficacy in Treatment-Naive Participants on April 24.
- Subpopulation Analyses for Highly Active Disease on April 24.
The trials enrolled 1,094 patients across 10 countries and evaluated the drug's effectiveness against teriflunomide.
TG Therapeutics, Inc. (TGTX) announced its financial results for Q4 and full year 2022, highlighting a pivotal year with the FDA approval and launch of BRIUMVI for multiple sclerosis. Product revenue for 2022 was approximately $2.6 million, primarily from UKONIQ, which was withdrawn in May 2022. Research and development expenses decreased to $125.4 million from $222.6 million in 2021, while selling, general, and administrative expenses also fell to $70.0 million. The net loss narrowed to $198.3 million from $348.1 million in 2021. Cash reserves stood at $174.1 million, projected to fund operations into mid-2024.