Business UpdateMay 20, 2026, 07:22 AM
Roivant's Brepocitinib gets FDA Priority Review for DM; $2.25B Moderna Settlement
AI Summary
Roivant Sciences Ltd. announced significant progress in its pipeline and a major legal settlement. The FDA accepted brepocitinib's New Drug Application (NDA) for dermatomyositis with Priority Review, setting a target action date in 3Q 2026, following positive Phase 3 VALOR study data. The company also reported a $2.25 billion global settlement with Moderna, resolving patent infringement litigation, with $950 million payable in July 2026. Additionally, Roivant completed a $550 million financing for Immunovant, discontinued batoclimab development to focus on IMVT-1402, and expects several key clinical trial data readouts in 2H 2026 and 2027-2028.
Key Highlights
- Brepocitinib NDA for dermatomyositis accepted by FDA with Priority Review; PDUFA date 3Q 2026.
- $2.25 billion global settlement with Moderna, with $950 million payable in July 2026.
- Consolidated cash, cash equivalents, and marketable securities totaled $4.3 billion as of March 31, 2026.
- Immunovant financing generated gross proceeds of approximately $550 million.
- Brepocitinib Phase 3 VALOR study in DM showed 46.5 mean TIS for 30 mg vs 31.2 for placebo (p=0.0006).
- Brepocitinib received FDA Breakthrough Therapy Designation for cutaneous sarcoidosis.
- IMVT-1402 trial in D2T RA showed ACR20, ACR50, ACR70 response rates of 72.7%, 54.5%, and 35.8%.
- Discontinued batoclimab development across all indications to focus fully on IMVT-1402.
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