---
schema_version: "secwatch.filing_event.v1"
accession: "0001140361-26-034735"
form_type: "8-K"
ticker: "ROIV"
cik: "0001635088"
company_name: "Roivant Sciences Ltd."
filed_at: "2026-08-27T21:24:44+00:00"
generated_at: "2026-08-27T21:26:35.957647+00:00"
event_type: "regulatory"
sentiment: "positive"
materiality_score: 1.0
calibrated_materiality_score: 1.0
confidence: "high"
source: SEC EDGAR
---

# FDA approves Roivant's LISRAYA (brepocitinib) for dermatomyositis; now available in U.S.

## Summary
- FDA approved LISRAYA (brepocitinib) 30 mg once-daily for adults with dermatomyositis; first targeted therapy approved for DM.
- In Phase 3 VALOR trial, 55% on LISRAYA achieved moderate/better improvement plus minimal/no steroid use vs 30% on placebo at 52 weeks.
- 62% on LISRAYA tapered to minimal/no steroids vs 38% on placebo; 45% came off steroids entirely vs 29% on placebo.
- LISRAYA is available immediately in U.S.; eligible patients may pay as little as $0/month via My Compass Support program.
- Investor call scheduled for August 28, 2026 at 8:00 a.m. ET to discuss the approval and pipeline updates.

## SEC filing metadata
- accession: 0001140361-26-034735
- form_type: 8-K
- ticker: ROIV
- cik: 0001635088
- company_name: Roivant Sciences Ltd.
- filed_at: 2026-08-27T21:24:44+00:00
- event_type: regulatory
- sentiment: positive
- materiality_score: 1.0
- calibrated_materiality_score: 1.0
- confidence: high
- sec_items: 7.01, 9.01
- EDGAR index: https://www.sec.gov/Archives/edgar/data/1635088/000114036126034735/0001140361-26-034735-index.htm
- EDGAR primary document: https://www.sec.gov/Archives/edgar/data/1635088/000114036126034735/ef20081229_8k.htm

## Machine-readable alternates
- HTML: https://secwatch.observer/filing/0001140361-26-034735
- JSON: https://secwatch.observer/filing/0001140361-26-034735.json
- Plain text: https://secwatch.observer/filing/0001140361-26-034735.txt

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