---
schema_version: "secwatch.filing_event.v1"
accession: "0001558370-22-005537"
form_type: "8-K"
ticker: "TGTX"
cik: "0001001316"
company_name: "TG THERAPEUTICS, INC."
filed_at: "2022-04-18T23:59:59+00:00"
generated_at: "2026-06-26T06:45:54.714699+00:00"
event_type: "regulatory"
sentiment: "negative"
materiality_score: 0.85
calibrated_materiality_score: 0.85
confidence: "high"
source: SEC EDGAR
---

# TG Therapeutics withdraws BLA/sNDA for U2 in CLL/SLL; pulls UKONIQ from sale

## Summary
- Voluntarily withdrew BLA/sNDA for U2 (ublituximab + umbralisib) for CLL/SLL based on updated OS data imbalance favoring control arm.
- Withdrew UKONIQ (umbralisib) from sale for accelerated-approved MZL and FL indications; FDA expected to withdraw approval.
- UNITY-CLL Phase 3 met primary PFS endpoint but updated OS showed increasing imbalance; ODAC meeting canceled.
- Company to focus on ublituximab BLA for relapsing MS (PDUFA Sept 28, 2022); conference call April 18 at 8:30 AM ET.

## SEC filing metadata
- accession: 0001558370-22-005537
- form_type: 8-K
- ticker: TGTX
- cik: 0001001316
- company_name: TG THERAPEUTICS, INC.
- filed_at: 2022-04-18T23:59:59+00:00
- event_type: regulatory
- sentiment: negative
- materiality_score: 0.85
- calibrated_materiality_score: 0.85
- confidence: high
- sec_items: 8.01, 9.01
- EDGAR index: https://www.sec.gov/Archives/edgar/data/1001316/000155837022005537/0001558370-22-005537-index.htm
- EDGAR primary document: https://www.sec.gov/Archives/edgar/data/1001316/000155837022005537/tgtx-20220415x8k.htm

## Machine-readable alternates
- HTML: https://secwatch.observer/filing/0001558370-22-005537
- JSON: https://secwatch.observer/filing/0001558370-22-005537.json
- Plain text: https://secwatch.observer/filing/0001558370-22-005537.txt

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