---
schema_version: "secwatch.filing_event.v1"
accession: "0001140361-23-030856"
form_type: "8-K"
ticker: "ROIV"
cik: "0001635088"
company_name: "Roivant Sciences Ltd."
filed_at: "2023-06-22T23:59:59+00:00"
generated_at: "2026-06-13T19:04:57.220439+00:00"
event_type: "other_material"
sentiment: "positive"
materiality_score: 0.65
calibrated_materiality_score: 0.65
confidence: "high"
source: SEC EDGAR
---

# Roivant reports positive chronic data for RVT-3101 in ulcerative colitis, efficacy improved from induction at week 56

## Summary
- At expected Phase 3 dose, Clinical Remission 36% at week 56 vs 29% at week 14; Endoscopic Improvement 50% vs 36%.
- In biomarker-positive patients, Clinical Remission 43% at week 56 (33% at week 14), Endoscopic Improvement 64% (47%).
- Favorable safety profile through 56 weeks; 0% neutralizing antibodies at week 56 at Phase 3 dose.
- First long-duration data for an anti-TL1A antibody; results support Phase 3 potential.

## SEC filing metadata
- accession: 0001140361-23-030856
- form_type: 8-K
- ticker: ROIV
- cik: 0001635088
- company_name: Roivant Sciences Ltd.
- filed_at: 2023-06-22T23:59:59+00:00
- event_type: other_material
- sentiment: positive
- materiality_score: 0.65
- calibrated_materiality_score: 0.65
- confidence: high
- sec_items: 8.01, 9.01
- EDGAR index: https://www.sec.gov/Archives/edgar/data/1635088/000114036123030856/0001140361-23-030856-index.htm
- EDGAR primary document: https://www.sec.gov/Archives/edgar/data/1635088/000114036123030856/brhc20054731_8k.htm

## Machine-readable alternates
- HTML: https://secwatch.observer/filing/0001140361-23-030856
- JSON: https://secwatch.observer/filing/0001140361-23-030856.json
- Plain text: https://secwatch.observer/filing/0001140361-23-030856.txt

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