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

Roivant Sciences Ltd.

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.

This headline and bullets were generated automatically by deepseek-v4-flash:cloud@v2 from the public filing. Read the source on SEC.gov before relying on any specific claim. Not investment advice. See methodology for how this pipeline works.