---
schema_version: "secwatch.filing_event.v1"
accession: "0001558370-22-000487"
form_type: "8-K"
ticker: "TGTX"
cik: "0001001316"
company_name: "TG THERAPEUTICS, INC."
filed_at: "2022-01-27T23:59:59+00:00"
generated_at: "2026-06-27T14:35:52.290537+00:00"
event_type: "regulatory"
sentiment: "negative"
materiality_score: 0.85
calibrated_materiality_score: 0.85
confidence: "high"
source: SEC EDGAR
---

# TG Therapeutics: updated UNITY-CLL OS data improves but FDA imposes partial clinical hold on U2 studies

## Summary
- Updated OS hazard ratio improved vs preliminary 1.23; still not statistically significant (Sep 2021 cutoff).
- FDA placed partial clinical hold on select U2 studies; no new enrollment, existing patients continue after reconsent.
- Partial hold based on same data as ODAC meeting scheduled for March/April 2022; no update expected before ODAC.
- Company nearing FDA submission of updated OS analysis; interim OS results may change as more events occur.

## SEC filing metadata
- accession: 0001558370-22-000487
- form_type: 8-K
- ticker: TGTX
- cik: 0001001316
- company_name: TG THERAPEUTICS, INC.
- filed_at: 2022-01-27T23:59:59+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/1001316/000155837022000487/0001558370-22-000487-index.htm
- EDGAR primary document: https://www.sec.gov/Archives/edgar/data/1001316/000155837022000487/tgtx-20220127x8k.htm

## Machine-readable alternates
- HTML: https://secwatch.observer/filing/0001558370-22-000487
- JSON: https://secwatch.observer/filing/0001558370-22-000487.json
- Plain text: https://secwatch.observer/filing/0001558370-22-000487.txt

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