other material
confidence high
sentiment positive
materiality 0.75
Immunovant gains FDA alignment for Phase 3 batoclimab trials in TED; reports FY2022 loss of $156.7M
Immunovant, Inc.
- FDA aligned on Phase 3 TED program: two placebo-controlled trials (100 patients each) initiating H2 2022; top-line data H1 2025.
- Phase 3 MG trial initiation on track by end of June 2022; top-line data expected H2 2024.
- Cash $493.8M as of March 31, 2022 provides runway into calendar year 2025.
- FY2022 net loss $156.7M ($1.43/share) vs FY2021 $107.4M ($1.22/share); R&D spend $101.8M.
- Company expects to announce two new batoclimab indications by August 2022.