Roivant Sciences Ltd.

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.

Roivant Sciences reported its financial results for the fourth quarter and fiscal year ended March 31, 2026, highlighted by a significant $2.25 billion global settlement with Moderna. The company achieved income from continuing operations, net of tax, of $355.7 million for the quarter, largely driven by the litigation settlement gain. Roivant also provided positive business updates, including strong clinical trial data for IMVT-1402, Breakthrough Therapy Designation for brepocitinib, and several upcoming commercial launches and clinical readouts, while maintaining a strong cash position of $4.3 billion.

Roivant Sciences announced a $2.25 billion global settlement with Moderna, resolving all pending patent-infringement litigation, with $950 million payable in July 2026. The company also reported positive Period 1 data for IMVT-1402 in difficult-to-treat rheumatoid arthritis, showing a 72.7% ACR20 response rate. Additionally, brepocitinib received Breakthrough Therapy Designation for cutaneous sarcoidosis and is expected to launch commercially in dermatomyositis by September 2026. Roivant ended the fiscal year with $4.3 billion in cash, cash equivalents, and marketable securities, while discontinuing batoclimab development.