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TG Therapeutics Announces Phase 1 Data Evaluating Azer-cel in Progressive Multiple Sclerosis in a Late-Breaking Oral Presentation at MSToronto2026

Business Wire•23/10/2026•10:55 ET
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Key Highlights

  • ➤Azer-cel Phase 1 showed no dose-limiting or high-grade CAR-T toxicities in 26 participants
  • ➤EDSS scores stable or improved in 89% of evaluable participants at Day 90 (16/18)
  • ➤Azer-cel produced at least 2.0-point EDSS improvements in three participants at Day 90
  • ➤Azer-cel depleted peripheral blood B-cells below 10 cells/µL in 96% of participants (25/26)
  • ➤Stable or improved walking performance reached 94% of evaluable participants at Day 90 (16/17)

Expert Statements

Michael S. Weiss, Chairman and Chief Executive Officer of TG Therapeutics

“These initial azer-cel results are particularly encouraging given that all patients entered the study with progressive disability despite prior treatment with high-efficacy therapies, including anti-CD20 treatment. The safety findings to date, together with evidence of B-cell depletion in both the blood and cerebrospinal fluid, demonstrate biological activity at doses that appear tolerable, while stable or improved disability scores in most subjects provide a potential signal of clinical activity. Of particular interest, five of the 18 evaluable patients experienced improvements in disability scores, including three patients with improvements of two or more points on the EDSS scale, an encouraging early finding in a disease where even slowing progression can represent an important therapeutic advance.”

Michael S. Weiss, Chairman and Chief Executive Officer of TG Therapeutics

“While these results remain preliminary, we believe an off-the-shelf CAR T-cell therapy has the potential to offer a meaningful new treatment option for patients with progressive MS, where substantial unmet need remains. We look forward to continuing dose escalation and evaluating longer-term outcomes, and we are grateful to the patients, their families, and the clinical teams who are making this research possible.”

TG Therapeutics Announces Phase 1 Data Evaluating Azer-cel in Progressive Multiple Sclerosis in a Late-Breaking Oral Presentation at MSToronto2026

First reported clinical evaluation of an allogeneic CD19-directed CAR T-cell therapy in progressive MS demonstrated an encouraging preliminary safety profile with no high-grade CAR-T associated toxicities observed

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