Highlights

  • Phase 1 azer-cel data in 26 progressive MS patients showed no dose-limiting toxicities and no Grade 3 or higher CRS.
  • Disability scores were stable or improved at Day 90 in 16 of 18 evaluable participants receiving the allogeneic CAR T therapy.
  • Seven-year ULTIMATE follow-up showed 88.3% of continuously treated BRIUMVI patients free of 24-week confirmed disability progression.
  • Second-quarter BRIUMVI U.S. net product Revenue rose about 64% to US$227.7 million, prompting higher 2026 guidance.

An experimental cell therapy moved into the spotlight for TG Therapeutics, Inc. (NASDAQ:TGTX) at the joint ACTRIMS-ECTRIMS meeting in Toronto. On 23 October 2026, the company presented initial Phase 1 results for azercabtagene zapreleucel (azer-cel), an off-the-shelf CD19-directed CAR T therapy, in people with progressive multiple sclerosis (MS) whose disease had worsened despite high-efficacy treatment.

The late-breaking oral presentation came two days after the company highlighted long-term and dosing data for BRIUMVI, its marketed anti-CD20 antibody for relapsing MS.

Early Azer-cel Findings in Hard-to-Treat Patients

The open-label TG-Azercel-101 study enrolled 26 participants with progressive MS, all of whom had shown progression independent of relapse activity within the prior year and had previously received anti-CD20 therapy. Patients received one of six dose levels after lymphodepletion, with a median follow-up of 4.9 months at the 3 September 2026 data cutoff.

No dose-limiting toxicities, Grade 3 or higher cytokine release syndrome or Grade 2 or higher neurotoxicity were reported. Expanded Disability Status Scale scores were stable or improved at Day 90 in 16 of 18 evaluable participants, and none of the 22 MRI-evaluable participants showed new inflammatory lesions. Chairman and Chief Executive Michael S. Weiss called the results encouraging but preliminary, and the company noted the study is small, uncontrolled and has short follow-up. Dose escalation continues.

Long-Term BRIUMVI Data and Simplified Dosing

Seven-year follow-up from the two ULTIMATE studies showed an annualized relapse rate of 0.018 at Year 7 for continuously treated BRIUMVI patients, with 88.3% free of 24-week confirmed disability progression versus 82.6% for patients switched from teriflunomide.

The ENHANCE study met its primary endpoint, showing that a single 600 mg Day 1 infusion delivered bioequivalent exposure to the approved two-infusion starting regimen, removing the need for a Day 15 infusion. A Phase 1 study of subcutaneous BRIUMVI showed mean bioavailability above 60% relative to intravenous dosing.

Revenue Momentum and Upcoming Readouts

In its second-quarter 2026 results on 3 August 2026, TG reported BRIUMVI U.S. net product revenue of US$227.7 million and total revenue of US$240.3 million. Net Income was US$7.8 million, or US$0.05 per share, as Research and Development spending rose to US$95.3 million, including about US$54.6 million for subcutaneous and secondary manufacturing. Cash, cash equivalents and Investment securities reached US$612.3 million on 30 June 2026.

The company raised its 2026 guidance to total global revenue of about US$950 million and BRIUMVI U.S. net product revenue of about US$890 million to US$905 million, and expects to exit 2026 at an annualized U.S. BRIUMVI revenue run rate of about US$1 billion. Topline data from the fully enrolled Phase 3 trial of quarterly subcutaneous BRIUMVI are expected by year-end 2026 or early 2027.