---
schema_version: "secwatch.filing_event.v1"
accession: "0001558370-22-019019"
form_type: "8-K"
ticker: "TGTX"
cik: "0001001316"
company_name: "TG THERAPEUTICS, INC."
filed_at: "2022-12-28T23:59:59+00:00"
generated_at: "2026-06-20T22:15:09.171608+00:00"
event_type: "regulatory"
sentiment: "positive"
materiality_score: 0.9
calibrated_materiality_score: 0.9
confidence: "high"
source: SEC EDGAR
---

# FDA approves TG Therapeutics' BRIUMVI for relapsing multiple sclerosis; launch expected Q1 2023

## Summary
- Approval based on ULTIMATE I & II Phase 3 trials showing annualized relapse rate reduction of 59% and 49% vs teriflunomide.
- BRIUMVI is the first anti-CD20 mAb for RMS with a 1-hour infusion twice a year after starting dose.
- U.S. commercial launch expected in Q1 2023.
- Conference call to discuss approval on Dec 29, 2022 at 8:30 AM ET.

## SEC filing metadata
- accession: 0001558370-22-019019
- form_type: 8-K
- ticker: TGTX
- cik: 0001001316
- company_name: TG THERAPEUTICS, INC.
- filed_at: 2022-12-28T23:59:59+00:00
- event_type: regulatory
- sentiment: positive
- materiality_score: 0.9
- calibrated_materiality_score: 0.9
- confidence: high
- sec_items: 8.01, 9.01
- EDGAR index: https://www.sec.gov/Archives/edgar/data/1001316/000155837022019019/0001558370-22-019019-index.htm
- EDGAR primary document: https://www.sec.gov/Archives/edgar/data/1001316/000155837022019019/tgtx-20221228x8k.htm

## Machine-readable alternates
- HTML: https://secwatch.observer/filing/0001558370-22-019019
- JSON: https://secwatch.observer/filing/0001558370-22-019019.json
- Plain text: https://secwatch.observer/filing/0001558370-22-019019.txt

This AI-assisted summary is a reading aid. Review the linked SEC EDGAR filing before relying on any specific claim.