---
schema_version: "secwatch.filing_event.v1"
accession: "0001140361-26-034854"
form_type: "8-K"
ticker: "ROIV"
cik: "0001635088"
company_name: "Roivant Sciences Ltd."
filed_at: "2026-08-28T20:31:33+00:00"
generated_at: "2026-08-28T20:34:29.316375+00:00"
event_type: "regulatory"
sentiment: "positive"
materiality_score: 0.85
calibrated_materiality_score: 0.85
confidence: "high"
source: SEC EDGAR
---

# FDA approves Roivant's LISRAYA (brepocitinib) for dermatomyositis at $35K WAC

## Summary
- FDA granted approval of LISRAYA (brepocitinib) for adult dermatomyositis on Aug 28, 2026.
- Wholesale acquisition cost set at $35,000 per 30-count bottle of 30 mg tablets.
- No additional financial or commercial launch details disclosed in the filing.

## SEC filing metadata
- accession: 0001140361-26-034854
- form_type: 8-K
- ticker: ROIV
- cik: 0001635088
- company_name: Roivant Sciences Ltd.
- filed_at: 2026-08-28T20:31:33+00:00
- event_type: regulatory
- sentiment: positive
- materiality_score: 0.85
- calibrated_materiality_score: 0.85
- confidence: high
- sec_items: 8.01, 9.01
- EDGAR index: https://www.sec.gov/Archives/edgar/data/1635088/000114036126034854/0001140361-26-034854-index.htm
- EDGAR primary document: https://www.sec.gov/Archives/edgar/data/1635088/000114036126034854/ef20081283_8k.htm

## Machine-readable alternates
- HTML: https://secwatch.observer/filing/0001140361-26-034854
- JSON: https://secwatch.observer/filing/0001140361-26-034854.json
- Plain text: https://secwatch.observer/filing/0001140361-26-034854.txt

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