---
schema_version: "secwatch.filing_event.v1"
accession: "0001558370-21-016373"
form_type: "8-K"
ticker: "TGTX"
cik: "0001001316"
company_name: "TG THERAPEUTICS, INC."
filed_at: "2021-11-30T23:59:59+00:00"
generated_at: "2026-06-28T04:44:07.878022+00:00"
event_type: "regulatory"
sentiment: "negative"
materiality_score: 0.75
calibrated_materiality_score: 0.75
confidence: "high"
source: SEC EDGAR
---

# FDA to hold ODAC meeting for TG Therapeutics' U2 BLA; PDUFA date likely extended

## Summary
- FDA notified TG Therapeutics it will host an ODAC meeting for the U2 BLA/sNDA for CLL/SLL.
- ODAC meeting targeted for March or April 2022; March 25, 2022 PDUFA date unlikely to be met.
- Early overall survival analysis showed HR 1.23 favoring control; excluding COVID deaths HR 1.04 (not significant).
- Company affirms belief in UKONIQ's differentiated safety profile and that data support approval.
- Conference call scheduled for November 30, 2021 at 8:30 AM ET to discuss regulatory updates.

## SEC filing metadata
- accession: 0001558370-21-016373
- form_type: 8-K
- ticker: TGTX
- cik: 0001001316
- company_name: TG THERAPEUTICS, INC.
- filed_at: 2021-11-30T23:59:59+00:00
- event_type: regulatory
- sentiment: negative
- materiality_score: 0.75
- calibrated_materiality_score: 0.75
- confidence: high
- sec_items: 8.01, 9.01
- EDGAR index: https://www.sec.gov/Archives/edgar/data/1001316/000155837021016373/0001558370-21-016373-index.htm
- EDGAR primary document: https://www.sec.gov/Archives/edgar/data/1001316/000155837021016373/tgtx-20211130x8k.htm

## Machine-readable alternates
- HTML: https://secwatch.observer/filing/0001558370-21-016373
- JSON: https://secwatch.observer/filing/0001558370-21-016373.json
- Plain text: https://secwatch.observer/filing/0001558370-21-016373.txt

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