Immunovant achieves FDA alignment to start Phase 3 trial for batoclimab in MG in 1H 2022

Immunovant, Inc.

FDA Division of Neurology 1 agreed to move forward; Phase 3 for batoclimab in myasthenia gravis starts 1H 2022.
Trial includes induction with 680mg and 340mg weekly subQ doses; primary efficacy: MG-ADL in AChR+ subjects at 12 weeks.
Follow-on periods will explore alternative dosing (lower maintenance, higher rescue). Safety database per FDA guidance.
Data readout expected in 2024; investor call scheduled for January 5, 2022 at 8 a.m. ET.

This headline and bullets were generated automatically by deepseek-v4-flash:cloud@v2 from the public filing. Read the source on SEC.gov before relying on any specific claim. Not investment advice. See methodology for how this pipeline works.