TG Therapeutics, Inc. TGTX
TG Therapeutics, Inc. (Nasdaq: TGTX) is a CNS/neurology/psychiatry drug developer. Its lead program, BRIUMVI (ublituximab-xiiy), is in Phase 3 for relapsing forms of multiple sclerosis (adults). Its next catalyst on record is subcutaneous ublituximab: Topline data from Phase 3 in RMS (Q4 2026).
Upcoming catalysts
No catalyst is dated to the next 30 days or to an FDA action date.
Next further out: subcutaneous ublituximab — Topline data from Phase 3 in RMS (Q4 2026). 1 catalyst on record beyond the next 30 days; subscribers see each with its filing sentence.
Pipeline
| Program | Indication | Modality | Stage |
|---|---|---|---|
| BRIUMVI (ublituximab-xiiy) IV | relapsing multiple sclerosis | antibody | Approved |
| Subcutaneous ublituximab | relapsing multiple sclerosis | antibody | Phase 3 |
| BRIUMVI simplified dosing (ENHANCE) | relapsing multiple sclerosis | antibody | Phase 3 |
| BRIUMVI | myasthenia gravis | antibody | Phase 2 |
| BRIUMVI | treatment-resistant schizophrenia | antibody | Phase 2 |
| azer-cel (allogeneic CD19 CAR T) | progressive multiple sclerosis and B-cell disorders | cell therapy | Phase 1 |
Recent results and decisions
- Aug 3, 2026met Phase 3 ENHANCE met its primary endpoint, showing bioequivalent exposure of a single 600 mg Day 1 initiation infusion versus the approved 150 mg/450 mg Day 1/Day 15 regimen.
The ENHANCE trial met its primary endpoint, demonstrating bioequivalent drug exposure between the currently approved BRIUMVI initiation infusion dosing regimen of 150 mg on Day 1 and 450 mg on Day 15 and a consolidated single 600 mg infusion on Day 1
Filing - Aug 3, 2026positive Phase 1 of subcutaneous ublituximab showed mean bioavailability above 60% relative to IV BRIUMVI with positive PD, safety and tolerability.
Subcutaneous BRIUMVI demonstrated mean bioavailability of greater than 60% relative to IV administration in the Phase 1 trial
Filing - Aug 3, 2026started Initiated a potentially registration-directed randomized Phase 2 trial of IV BRIUMVI maintenance after efgartigimod induction in myasthenia gravis.
Initiated a potentially registration-directed randomized phase 2 clinical trial evaluating IV BRIUMVI as a maintenance therapy following induction with efgartigimod in adult patients with MG
Filing
For subscribers
- Cash runway against each catalyst, with the company's own runway statement
- Track record: every Phase 3 readout, FDA decision and guidance slip since 2014
- Expected move for each dated catalyst, from comparable past events
- Phase 2 evidence behind each Phase 3 readout
- Companies on the same target or class
- Full catalyst list with filing sentences, deals, registered trials, Excel export
Other phase 3 CNS/neurology/psychiatry companies
The free Monday brief
Last week's readouts and FDA decisions and the dated catalysts in the week ahead, each with its filing sentence.