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 (TGTX) reported preliminary Phase 1 results for azer-cel, an investigational donor-derived CAR T-cell therapy for progressive multiple sclerosis. Among evaluable participants, disability scores were stable or improved in 89% at Day 90 and 88% at Day 180 (7/8). Three participants improved by at least 2.0 points on the Expanded Disability Status Scale at Day 90.
The study treated 26 participants, with no dose-limiting toxicities, Grade ≥3 cytokine release syndrome, Grade ≥2 immune-cell-associated neurological toxicity, or Grade ≥3 infections observed. At Day 90, walking, hand function and cognitive processing speed were stable or improved in most evaluable participants; none of 22 assessed by MRI had new or enlarging lesions. Results remain preliminary: the open-label study has few participants and short follow-up, with a median of 4.9 months at September 3, 2026. Dose escalation and longer-term follow-up continue.
TG Therapeutics (NASDAQ: TGTX) presented updated BRIUMVI clinical results at MSToronto2026, including seven-year outcomes and data on alternative dosing regimens. Among continuously treated patients, 88.3% remained free from disability progression confirmed over 24 weeks at seven years, versus 82.6% not reported directly for the comparison group.
The Phase 3 ENHANCE trial met its primary endpoint: a proposed single 600 mg initiation infusion produced equivalent drug exposure to the approved two-infusion regimen. Phase 1 subcutaneous dosing showed mean bioavailability greater than 60% relative to intravenous administration; modeling supports quarterly dosing under evaluation in a fully enrolled Phase 3 trial. In the observational ENABLE study, 99.2% of 1,076 participants remained relapse-free. Initial Phase 1 azer-cel results in primary progressive multiple sclerosis are scheduled for presentation on October 23, 2026.
TG Therapeutics (TGTX) announced publication of a five-year indirect comparison of BRIUMVI with ocrelizumab and ofatumumab in relapsing multiple sclerosis. Published in Multiple Sclerosis and Related Disorders, the analysis reweighted data from 545 BRIUMVI-treated participants to match comparator trial populations rather than comparing treatments head-to-head.
BRIUMVI was associated with 44% and 49% lower relative hazards of disability progression confirmed over 24 weeks versus ocrelizumab and ofatumumab, respectively. Estimated progression rates at 240 weeks were 9.3% versus 16.1% and 9.4% versus 17.9%. Adjusted annualized relapse rates declined from Year 1 to Year 5 in both comparisons. The findings are exploratory: the method cannot adjust for unmeasured differences between trials, and confirmation through direct comparative studies or robust real-world evidence is needed.
TG Therapeutics (TGTX) scheduled presentations on azer-cel and BRIUMVI at MSToronto2026, taking place October 21–23, 2026, in Toronto, Canada. A late-breaking oral presentation on October 23 will cover initial Phase 1 results for azer-cel in primary progressive multiple sclerosis. Azer-cel is a donor-derived CAR T-cell therapy designed to target CD19.
BRIUMVI presentations include Phase 3 ENHANCE data on an investigational single-dose initiation schedule, full Phase 1 subcutaneous results, seven-year safety and efficacy outcomes, and real-world evidence. Regular abstracts are available now; late-breaking abstracts will be available October 21, 2026.
TG Therapeutics (TGTX) will participate in the H.C. Wainwright 28th Annual Global Investment Conference on September 14–16, 2026. Chairman and CEO Michael S. Weiss is scheduled for a fireside chat on Monday, September 14, 2026, at 12:00pm ET. A live webcast of the session will be accessible on the Events page within the Investors & Media section of the company’s website.
TG Therapeutics (TGTX) will participate in the Cantor Global Healthcare Conference being held September 9–11, 2026. Chairman and CEO Michael S. Weiss is scheduled for a fireside chat on Wednesday, September 9, 2026, at 11:30am ET.
A live webcast will be accessible via the Events page in the Investors & Media section of the company’s website.
Precision BioSciences (Nasdaq: DTIL) reported Q2 2026 results and a business update, highlighting first clinical biopsy evidence from the Phase 1 ELIMINATE-B trial that PBGENE-HBV directly reduces hepatitis B cccDNA. A patient showed a 1-log reduction with <1% cccDNA remaining after two 0.4 mg/kg doses, and repeat dosing in another patient increased anti-cccDNA effect. pgRNA became durably undetectable in 100% of evaluable patients, with substantial S-antigen declines across all dose levels and no dose-limiting toxicities in 16 patients.
PBGENE-DMD advanced with two active Phase 1/2 FUNCTION-DMD trial sites now recruiting, and initial safety data targeted for year-end 2026. Cash, cash equivalents and restricted cash were $112.4 million at June 30, 2026, which Precision expects to fund operations and PBGENE-HBV and PBGENE-DMD data milestones through 2028. Q2 2026 R&D expenses were $12.4 million, G&A $6.8 million, and net loss was $32.7 million, including $13.5 million of other expense driven primarily by non-cash warrant liability revaluation.
TG Therapeutics (NASDAQ:TGTX) reported second quarter 2026 total global revenue of $240.3 million, including U.S. BRIUMVI net product revenue of $227.7 million, up about 64% year over year. Net product revenue reached $235.8 million, while license, milestone, royalty and other revenue was $4.5 million.
R&D expense rose to $95.3 million and SG&A to $82.1 million, driven by subcutaneous BRIUMVI manufacturing, secondary manufacturer start-up and commercialization costs. Net income was $7.8 million, and cash, cash equivalents and investment securities totaled $612.3 million at June 30, 2026.
The company raised full-year 2026 total global revenue guidance to ~$950 million and BRIUMVI U.S. net product revenue guidance to $890–$905 million, and guided operating expenses (R&D plus SG&A) to $350–$400 million, plus about $100 million in subcutaneous BRIUMVI manufacturing and secondary manufacturer costs. TG Therapeutics highlighted positive Phase 3 ENHANCE data supporting a single 600 mg initiation infusion for BRIUMVI in RMS, encouraging Phase 1 subcutaneous BRIUMVI data, and progress in myasthenia gravis, schizophrenia, and its azer-cel cell therapy program.
TG Therapeutics (NASDAQ:TGTX) will host a conference call on Monday, August 3, 2026 at 8:30 AM ET to discuss its second quarter 2026 financial results and provide a business outlook for the remainder of 2026, led by Chairman and CEO Michael S. Weiss.
Investors can join by calling 1-877-407-8029 (U.S.) or 1-201-689-8029 (international), using the conference title “TG Therapeutics Earnings Call,” or via live webcast on the Events page in the Investors & Media section of the company’s website. An audio replay will be available online for 30 days, and financial results will be released in a press statement prior to the call.
TG Therapeutics (NASDAQ:TGTX) has started a Phase 2, open-label, single-arm, multicenter trial of BRIUMVI (ublituximab-xiiy) in about 60 adults with treatment-resistant schizophrenia.
Participants receive intravenous BRIUMVI plus standard antipsychotics. The primary endpoint is ≥20% PANSS total score reduction at Week 12.