secwatch.observer — SEC 8-K summary
======================================

Issuer:     TG THERAPEUTICS, INC. (TGTX)
CIK:        0001001316
Form:       8-K
Filed at:   2021-11-30T23:59:59+00:00
Accession:  0001558370-21-016373
Event type: regulatory
Sentiment:  negative
Materiality: 0.75
Item codes: 8.01, 9.01
LLM model:  deepseek-v4-flash:cloud@v2

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

- 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.

Source:
  EDGAR index:    https://www.sec.gov/Archives/edgar/data/1001316/000155837021016373/0001558370-21-016373-index.htm
  Primary doc:    https://www.sec.gov/Archives/edgar/data/1001316/000155837021016373/tgtx-20211130x8k.htm
  HTML page:      https://secwatch.observer/filing/0001558370-21-016373

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