---
schema_version: "secwatch.filing_event.v1"
accession: "0001140361-25-035190"
form_type: "8-K"
ticker: "ROIV"
cik: "0001635088"
company_name: "Roivant Sciences Ltd."
filed_at: "2025-09-17T23:59:59+00:00"
generated_at: "2026-05-17T06:22:18.123335+00:00"
event_type: "other_material"
sentiment: "positive"
materiality_score: 0.8
calibrated_materiality_score: 0.8
confidence: "high"
source: SEC EDGAR
---

# Roivant/Priovant: Phase 3 VALOR brepocitinib meets primary endpoint in dermatomyositis; NDA filing 1H 2026

## Summary
- Brepocitinib 30 mg achieved week-52 mean TIS 46.5 vs placebo 31.2 (p=0.0006); all 9 key secondary endpoints met.
- 62% of brepocitinib patients on background steroids achieved steroid dose ≤2.5 mg/day vs 34% placebo; 42% off steroids vs 23%.
- Safety profile consistent with prior brepocitinib trials; no increase in AESIs in active arm vs placebo.
- NDA submission for brepocitinib in dermatomyositis planned for calendar first half 2026.

## SEC filing metadata
- accession: 0001140361-25-035190
- form_type: 8-K
- ticker: ROIV
- cik: 0001635088
- company_name: Roivant Sciences Ltd.
- filed_at: 2025-09-17T23:59:59+00:00
- event_type: other_material
- sentiment: positive
- materiality_score: 0.8
- calibrated_materiality_score: 0.8
- confidence: high
- sec_items: 7.01, 8.01, 9.01
- EDGAR index: https://www.sec.gov/Archives/edgar/data/1635088/000114036125035190/0001140361-25-035190-index.htm
- EDGAR primary document: https://www.sec.gov/Archives/edgar/data/1635088/000114036125035190/ef20055655_8k.htm

## Machine-readable alternates
- HTML: https://secwatch.observer/filing/0001140361-25-035190
- JSON: https://secwatch.observer/filing/0001140361-25-035190.json
- Plain text: https://secwatch.observer/filing/0001140361-25-035190.txt

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