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 develops and commercializes therapies for B-cell diseases, with news centered on BRIUMVI (ublituximab-xiiy), its anti-CD20 monoclonal antibody for adult patients with relapsing forms of multiple sclerosis. Company updates commonly cover U.S. net product revenue, global revenue targets, commercial demand, and international commercialization economics tied to BRIUMVI.
Recurring developments also include clinical and real-world data for BRIUMVI in relapsing multiple sclerosis, presentations and publications from multiple sclerosis studies, and development work on a subcutaneous formulation. Corporate news includes financing arrangements, share repurchase authorization updates, operating-expense guidance, and business outlook commentary alongside quarterly and annual results.
TG Therapeutics (NASDAQ: TGTX) presented updated data from the ENHANCE Phase 3b trial of BRIUMVI® (ublituximab-xiiy) for relapsing forms of multiple sclerosis (RMS) at the 2024 ECTRIMS meeting. Key findings include:
1. Patients switching from prior anti-CD20 treatment can successfully eliminate the initial BRIUMVI infusion.
2. Rapid 30-minute BRIUMVI infusions are well-tolerated, with only mild (Grade 1) infusion-related reactions.
3. 97% of 1-hour infusions for B-cell depleted patients were completed without interruption.
4. 12 patients received 30-minute infusions at week 24, all completed without interruption.
The company aims to improve patient tolerability and convenience, potentially leading to label-enabling studies for optimized dosing regimens.
TG Therapeutics (NASDAQ: TGTX) presented updated 5-year data from the ULTIMATE I & II Phase 3 trials of BRIUMVI® (ublituximab-xiiy) in relapsing multiple sclerosis (RMS) at the 2024 ECTRIMS meeting. Key findings include:
- 92% of patients were free from disability progression after 5 years of BRIUMVI treatment
- Annualized relapse rate in year 5 was 0.020 (1 relapse per 50 patient-years)
- Safety profile remained consistent over 5 years with no new signals
- Patients who switched from teriflunomide to BRIUMVI saw a 58.4% reduction in relapse rate
- 17% of patients on continuous BRIUMVI achieved confirmed disability improvement
The data support BRIUMVI as a valuable long-term treatment option for RMS patients, demonstrating sustained clinical efficacy and a tolerable safety profile.
TG Therapeutics (NASDAQ: TGTX) has announced upcoming data presentations for BRIUMVI (ublituximab-xiiy) at the 2024 European Committee for Treatment and Research in Multiple Sclerosis (ECTRIMS) annual meeting. The presentations will highlight data from the ULTIMATE I & II Phase 3 trials and the ENHANCE Phase 3b trial, evaluating BRIUMVI in patients with relapsing forms of multiple sclerosis (RMS).
The meeting will be held from September 18-20, 2024, in Copenhagen, Denmark. Three poster presentations are scheduled, covering topics such as five-year results of ublituximab in RMS, efficacy and tolerability after transitioning from different therapies, and comparison of Multiple Sclerosis Disease Activity (MSDA) Test results between ublituximab and teriflunomide treatments.
HealthCare Royalty (HCRx) and Blue Owl Capital have provided a $250 million term loan facility to TG Therapeutics (NASDAQ: TGTX), a biopharmaceutical company focused on B-cell diseases. The loan, maturing on August 2, 2029, supports TG's commercialization of BRIUMVI®, an anti-CD20 monoclonal antibody for treating relapsing forms of multiple sclerosis. BRIUMVI® generated $89 million in U.S. net revenue in 2023. An additional $100 million facility is available at mutual option. This financing demonstrates confidence in TG Therapeutics' commercial progress and provides capital for its business objectives.
TG Therapeutics (NASDAQ: TGTX) reported strong Q2 2024 financial results, with U.S. BRIUMVI net revenue of $72.6 million, representing over 350% growth year-over-year. The company raised its full-year 2024 U.S. BRIUMVI net revenue guidance to $290-$300 million. TG Therapeutics achieved positive cash flow in Q2 2024 and established a $250 million credit facility to repay existing debt and initiate a share repurchase program. The company also made progress in its R&D pipeline, initiating a phase 1 study for subcutaneous ublituximab in RMS patients and receiving FDA IND clearance for azer-cel in progressive MS. With approximately 5,850 new patient prescriptions for BRIUMVI since launch, TG Therapeutics continues to show strong commercial momentum.
TG Therapeutics (NASDAQ: TGTX) has announced a conference call scheduled for Tuesday, August 6, 2024, at 8:30 AM ET to discuss the company's second quarter 2024 financial results and provide a business outlook for 2024. The call will be hosted by Michael S. Weiss, Chairman and CEO. Participants can join by calling 1-877-407-8029 (U.S.) or 1-201-689-8029 (outside U.S.). A live webcast will be available on the company's website, and an audio recording will be accessible for 30 days after the call. TG Therapeutics will release its financial results in a press release prior to the call.
TG Therapeutics (NASDAQ: TGTX) announced that CEO Michael S. Weiss will participate in the Goldman Sachs 45th Annual Global Healthcare Conference, held at the Loews Miami Beach Hotel, from June 10-13, 2024.
Weiss is scheduled for a fireside chat on June 11, 2024, at 1:20 PM ET. A live webcast will be available on the company's Investors & Media section.
TG Therapeutics (NASDAQ: TGTX) will participate in the Jefferies Global Healthcare Conference on June 5-6, 2024, at the Marriott Marquis, New York City. Michael S. Weiss, Chairman and CEO, will conduct a fireside chat on June 5, 2024, at 1:30 PM ET. The event will be webcast live and accessible on TG Therapeutics' website.
The conference appearance aims to provide updates on the company's progress and strategies, potentially impacting investor perception and stock performance.
TG Therapeutics presented study designs for post-marketing studies of BRIUMVI® (ublituximab) at the 2024 Consortium of Multiple Sclerosis Centers annual meeting. The studies focus on evaluating BRIUMVI's presence in breast milk and its impact on pregnancy and infant outcomes. These presentations are now publicly available on the company's website.
TG Therapeutics (NASDAQ: TGTX) has announced the schedule for upcoming presentations regarding BRIUMVI® (ublituximab) at the 2024 Consortium of Multiple Sclerosis Centers (CMSC) Annual Meeting, set to take place from May 29 to June 1 in Nashville, Tennessee.
The presentations will highlight post-marketing studies on BRIUMVI for patients with relapsing forms of multiple sclerosis (RMS). Key sessions include:
- 'A Post-Marketing Study Evaluating the Presence and Concentration of BRIUMVI in Breast Milk' scheduled for May 30, led by Dr. Riley Bove from UCSF.
- 'BRIUMVI Pregnancy Registry: A Prospective Study of Pregnancy and Infant Outcomes in Patients Treated with BRIUMVI' also on May 30, led by Dr. Riley Bove from UCSF.
Abstracts are available online on the CMSC meeting website.