other material
confidence high
sentiment positive
materiality 0.75
Roivant/Immunovant: Phase 2a batoclimab 76% response in GD; pivotal IMVT-1402 trial by year end
Roivant Sciences Ltd.
- High-dose batoclimab (680mg SC weekly) achieved 76% response rate and 56% ATD-free response in uncontrolled GD at week 12.
- Mean IgG reduction of 77% correlated with clinical outcomes; ≥70% IgG reduction yielded 60% ATD-free response vs 23%.
- FDA cleared IND for IMVT-1402; pivotal trial in Graves' Disease expected to initiate by December 31, 2024.
- Real-world data shows 25-30% of GD patients per year are uncontrolled on ATDs, representing a large commercial opportunity.