secwatch.observer — SEC 8-K summary
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Issuer:     TG THERAPEUTICS, INC. (TGTX)
CIK:        0001001316
Form:       8-K
Filed at:   2022-04-18T23:59:59+00:00
Accession:  0001558370-22-005537
Event type: regulatory
Sentiment:  negative
Materiality: 0.85
Item codes: 8.01, 9.01
LLM model:  deepseek-v4-flash:cloud@v2

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

Source:
  EDGAR index:    https://www.sec.gov/Archives/edgar/data/1001316/000155837022005537/0001558370-22-005537-index.htm
  Primary doc:    https://www.sec.gov/Archives/edgar/data/1001316/000155837022005537/tgtx-20220415x8k.htm
  HTML page:      https://secwatch.observer/filing/0001558370-22-005537

License: Source filings: public domain (SEC EDGAR). Summaries (headline + bullets): CC-BY-4.0; attribute https://secwatch.observer