Phase 3 ENHANCE met primary endpoint: single Day 1 BRIUMVI infusion
TG reported results from its Phase 3 study of BRIUMVI (ublituximab-xiiy) for relapsing forms of multiple sclerosis on May 27, 2026. The study met its main goal.
Plain-English summary generated from this entry’s own fields (drug, condition, stage, date). Glossary
- Company
- TG Therapeutics, Inc. TGTX
- Drug
- BRIUMVI (ublituximab-xiiy)
- For
- relapsing forms of multiple sclerosis
- Stage
- Phase 3 · the last stage before a drug can be approved
- When
- May 27, 2026
- Source note
- ENHANCE showed bioequivalent 16-week exposure (GMR ~1.0, 90% CI within 0.80-1.25) between a consolidated single 600 mg Day 1 infusion and the approved Day 1/Day 15 split regimen, with no new safety signals. TG targeted a supplemental BLA in 2H 2026.
- Checked
- Checked by a person when it was added
- Source: sec.gov ↗ — where this entry was taken from
- SEC filings (8-K) ↗ — press releases are attached to 8-K filings
- ClinicalTrials.gov ↗ — trials of this drug
- TGTX headlines on this site
TG presents data on ublituximab (BRIUMVI IV) for relapsing multiple sclerosis (Day 1 + Day 15 combined dosing regimen) at a medical meeting in the second half of 2026 (no exact date yet). New numbers at a conference can move the stock as much as a formal announcement.
More details
- Entry
- Full Phase 3 ENHANCE trial results presentation (IV BRIUMVI rapid dosing) · Data presented at a medical meeting
- Drug
- ublituximab (BRIUMVI IV)
- For
- relapsing multiple sclerosis (Day 1 + Day 15 combined dosing regimen)
- Stage
- Phase 3 · the last stage before a drug can be approved
- When
- H2 2026 · the company gave a window, not a day
- Source note
- Company plans to present full ENHANCE results later in 2026 following positive topline announcement.
- Checked
- Checked by a person when it was added
- Verify it
- Source: biospace.com ↗ — where this entry was taken from
- SEC filings (8-K) ↗ — press releases are attached to 8-K filings
- ClinicalTrials.gov ↗ — trials of this drug
- TGTX headlines on this site
Plain-English summary generated from this entry’s own fields (drug, condition, stage, date). Glossary · Open this catalyst’s page
TG expects to report results from its Phase 1 study of azercabtagene zapreleucel (azer-cel, allogeneic CD19 CAR-T) for progressive multiple sclerosis in the second half of 2026 (no exact date yet). Phase 1 is an early safety study in a small group of people.
More details
- Entry
- Preliminary Phase 1 azer-cel data in progressive MS · Clinical trial results (readout / topline data)
- Drug
- azercabtagene zapreleucel (azer-cel, allogeneic CD19 CAR-T)
- For
- progressive multiple sclerosis
- Stage
- Phase 1 · an early safety study in a small group of people
- When
- H2 2026 · the company gave a window, not a day
- Source note
- Company guidance: present preliminary Phase 1 azer-cel data in progressive MS in the second half of 2026.
- Checked
- Checked by a person when it was added
- Verify it
- Source: biospace.com ↗ — where this entry was taken from
- SEC filings (8-K) ↗ — press releases are attached to 8-K filings
- ClinicalTrials.gov ↗ — trials of this drug
- TGTX headlines on this site
Plain-English summary generated from this entry’s own fields (drug, condition, stage, date). Glossary · Open this catalyst’s page
TG expects to report results from its Phase 3 study of ublituximab subcutaneous (BRIUMVI SC) for relapsing multiple sclerosis in Q4 2026 (Oct–Dec) (no exact date yet). Phase 3 is the last stage before a drug can be approved, so this result usually decides the program’s future.
More details
- Entry
- Subcutaneous BRIUMVI Phase 3 topline now year-end 2026 or early 2027 · Clinical trial results (readout / topline data)
- Drug
- ublituximab subcutaneous (BRIUMVI SC)
- For
- relapsing multiple sclerosis
- Stage
- Phase 3 · the last stage before a drug can be approved
- When
- Q4 2026 · the company gave a window, not a day
- Source note
- existing TGTX|readout|2026-Q4 SC BRIUMVI item; Q2 2026 PR (Aug 3, 2026) now guides topline to year-end 2026/first quarter 2027, i.e. may slip into 2027-Q1. Date kept at 2026-Q4 as the earliest stated window.
- Checked
- Checked by a person when it was added
- Verify it
- Source: biospace.com ↗ — where this entry was taken from
- SEC filings (8-K) ↗ — press releases are attached to 8-K filings
- ClinicalTrials.gov ↗ — trials of this drug
- TGTX headlines on this site
Plain-English summary generated from this entry’s own fields (drug, condition, stage, date). Glossary · Open this catalyst’s page