TGTX TG THERAPEUTICS, INC.
Price Chart
Executive Summary
TG Therapeutics announced positive Phase 1 data for a subcutaneous formulation of BRIUMVI (ublituximab-xiiy), showing favorable pharmacokinetics, safety, and tolerability. The data support the ongoing Phase 3 trial evaluating quarterly subcutaneous dosing, with top-line Phase 3 results expected year-end 2026 or early 2027. If approved, subcutaneous BRIUMVI could be the first self-administered, at-home, quarterly anti-CD20 therapy for multiple sclerosis, potentially doubling the addressable market for the BRIUMVI franchise.
Actionable Insight
The positive Phase 1 data significantly de-risks the subcutaneous BRIUMVI program, which could nearly double the addressable market if approved. Traders should watch for Phase 3 top-line data (late 2026/early 2027) and the device bridging study later this year. The stock has strong historical momentum on positive pipeline catalysts.
Key Facts
- Phase 1 data showed mean bioavailability >60% vs IV, with lower bound of 95% CI exceeding 55%.
- PK modeling supports non-inferior total drug exposure for quarterly SC dosing (GMR 1.21, lower bound 90% CI 1.15) vs IV.
- No new safety signals; local injection-site reactions in <5% of patients; systemic injection reactions in ~21%, all resolved.
- Phase 3 trial fully enrolled; top-line results expected late 2026 or early 2027; potential approval in 2028.
- SC BRIUMVI could be first self-administered, at-home, quarterly anti-CD20 therapy for MS, potentially doubling addressable market.
- Over 100 patients treated in Phase 1; more than 225 SC injections administered, >75% at 400 mg dose.
Financial Impact
No financial figures provided in filing. Market cap is $5.6B. Positive Phase 1 data de-risks Phase 3 and supports potential market expansion for BRIUMVI franchise.
Risk Factors
- Phase 3 trial may fail to meet primary endpoint despite positive Phase 1 data.
- Regulatory approval not guaranteed; FDA may require additional studies.
- Commercial adoption of SC formulation may be slower than anticipated.
- Competition from other anti-CD20 therapies and MS treatments.
Market Snapshot
Documents Analyzed
This report is based on 5 SEC documents filed with EDGAR.
| Document | Accession Number |
|---|---|
| 8-K Filing (Primary) | 0001437749-26-019262 |
| Document: tgtx20260602_8k.htm | 0001437749-26-019262 |
| Document: 0001437749-26-019262-index-headers.html | 0001437749-26-019262 |
| Document: 0001437749-26-019262-index.html | 0001437749-26-019262 |
| Document: 0001437749-26-019262.txt | 0001437749-26-019262 |
Filters
| Type | Now | ||||
|---|---|---|---|---|---|
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Jun 11, 2026
1d ago
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Institutional Cluster
| $48.03 awaiting T+1 | awaiting T+1 | — | $49.52 (+3.10%) |
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Jun 3, 2026
9d ago
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8-K
| $40.11 $40.56 | ▲ +1.12% | ▲ +0.72% | $49.52 (+23.46%) |
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Jun 3, 2026
9d ago
|
Press Release
| $40.11 $40.56 | ▲ +1.12% | ▲ +0.72% | $49.52 (+23.46%) |
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Jun 1, 2026
11d ago
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Press Release
| $37.41 $36.64 | ▼ −2.06% | ▼ −2.20% | $49.52 (+32.37%) |
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May 27, 2026
16d ago
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8-K
| $38.82 $37.94 | ▼ −2.27% | ▼ −2.51% | $49.52 (+27.56%) |
|
May 6, 2026
5w ago
|
8-K
| $41.97 $43.03 | ▲ +2.51% | ▲ +2.84% | $49.52 (+17.99%) |
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Apr 30, 2026
6w ago
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Press Release
| $33.78 $33.85 | ▲ +0.21% | ▼ −0.01% | $49.52 (+46.60%) |
|
Apr 22, 2026
7w ago
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Press Release
| $38.31 $36.92 | ▼ −3.63% | ▼ −3.23% | $49.52 (+29.26%) |
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Apr 15, 2026
8w ago
|
Press Release
| $34.60 $34.30 | ▼ −0.87% | ▼ −1.12% | $49.52 (+43.12%) |
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Mar 19, 2026
12w ago
|
Press Release
| $30.36 $30.07 | ▼ −0.96% | ▲ +0.79% | $49.52 (+63.11%) |
US Market Status
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