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

Issuer:     TG THERAPEUTICS, INC. (TGTX)
CIK:        0001001316
Form:       8-K
Filed at:   2022-12-28T23:59:59+00:00
Accession:  0001558370-22-019019
Event type: regulatory
Sentiment:  positive
Materiality: 0.90
Item codes: 8.01, 9.01
LLM model:  deepseek-v4-flash:cloud@v2

FDA approves TG Therapeutics' BRIUMVI for relapsing multiple sclerosis; launch expected Q1 2023
--------------------------------------------------------------------------------

- Approval based on ULTIMATE I & II Phase 3 trials showing annualized relapse rate reduction of 59% and 49% vs teriflunomide.
- BRIUMVI is the first anti-CD20 mAb for RMS with a 1-hour infusion twice a year after starting dose.
- U.S. commercial launch expected in Q1 2023.
- Conference call to discuss approval on Dec 29, 2022 at 8:30 AM ET.

Source:
  EDGAR index:    https://www.sec.gov/Archives/edgar/data/1001316/000155837022019019/0001558370-22-019019-index.htm
  Primary doc:    https://www.sec.gov/Archives/edgar/data/1001316/000155837022019019/tgtx-20221228x8k.htm
  HTML page:      https://secwatch.observer/filing/0001558370-22-019019

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