---
schema_version: "secwatch.filing_event.v1"
accession: "0001764013-21-000129"
form_type: "8-K"
ticker: "IMVT"
cik: "0001764013"
company_name: "Immunovant, Inc."
filed_at: "2021-12-30T23:59:59+00:00"
generated_at: "2026-06-27T21:42:35.578520+00:00"
event_type: "regulatory"
sentiment: "positive"
materiality_score: 0.75
calibrated_materiality_score: 0.75
confidence: "high"
source: SEC EDGAR
---

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

## Summary
- 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.

## SEC filing metadata
- accession: 0001764013-21-000129
- form_type: 8-K
- ticker: IMVT
- cik: 0001764013
- company_name: Immunovant, Inc.
- filed_at: 2021-12-30T23:59:59+00:00
- event_type: regulatory
- sentiment: positive
- materiality_score: 0.75
- calibrated_materiality_score: 0.75
- confidence: high
- sec_items: 7.01, 9.01
- EDGAR index: https://www.sec.gov/Archives/edgar/data/1764013/000176401321000129/0001764013-21-000129-index.htm
- EDGAR primary document: https://www.sec.gov/Archives/edgar/data/1764013/000176401321000129/imvt-20211230.htm

## Machine-readable alternates
- HTML: https://secwatch.observer/filing/0001764013-21-000129
- JSON: https://secwatch.observer/filing/0001764013-21-000129.json
- Plain text: https://secwatch.observer/filing/0001764013-21-000129.txt

This AI-assisted summary is a reading aid. Review the linked SEC EDGAR filing before relying on any specific claim.