---
schema_version: "secwatch.filing_event.v1"
accession: "0001140361-24-040507"
form_type: "8-K"
ticker: "ROIV"
cik: "0001635088"
company_name: "Roivant Sciences Ltd."
filed_at: "2024-09-09T23:59:59+00:00"
generated_at: "2026-05-31T05:55:17.573333+00:00"
event_type: "other_material"
sentiment: "positive"
materiality_score: 0.75
calibrated_materiality_score: 0.75
confidence: "high"
source: SEC EDGAR
---

# Roivant/Immunovant: Phase 2a batoclimab 76% response in GD; pivotal IMVT-1402 trial by year end

## Summary
- 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.

## SEC filing metadata
- accession: 0001140361-24-040507
- form_type: 8-K
- ticker: ROIV
- cik: 0001635088
- company_name: Roivant Sciences Ltd.
- filed_at: 2024-09-09T23:59:59+00:00
- event_type: other_material
- 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/1635088/000114036124040507/0001140361-24-040507-index.htm
- EDGAR primary document: https://www.sec.gov/Archives/edgar/data/1635088/000114036124040507/ef20035648_8k.htm

## Machine-readable alternates
- HTML: https://secwatch.observer/filing/0001140361-24-040507
- JSON: https://secwatch.observer/filing/0001140361-24-040507.json
- Plain text: https://secwatch.observer/filing/0001140361-24-040507.txt

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