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 biopharmaceutical innovator advancing therapies for B-cell malignancies and autoimmune disorders. This dedicated news hub provides investors and industry professionals with essential updates on clinical developments, regulatory milestones, and corporate strategies.
Access real-time announcements including trial results, FDA submissions, and partnership agreements. Our curated collection ensures you never miss critical updates about ublituximab (BRIUMVI), PI3K delta inhibitors, or emerging pipeline candidates.
Key content categories include quarterly earnings reports, scientific conference presentations, manufacturing updates. All materials are sourced directly from company filings and verified industry publications.
Bookmark this page for streamlined tracking of TGTX's progress in developing glycoengineered antibody therapies and maintaining compliance with financial disclosure requirements. Check regularly for authoritative updates on this NASDAQ-listed biotech pioneer.
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.
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