regulatory
confidence high
sentiment positive
materiality 0.90
FDA approves TG Therapeutics' BRIUMVI for relapsing multiple sclerosis; launch expected Q1 2023
TG THERAPEUTICS, INC.
- 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.