Roivant Sciences Announces FDA Approval for LISRAYA™ (brepocitinib) for Dermatomyositis

Roivant Sciences Ltd. has announced a significant regulatory milestone in a Form 8-K filing. The U.S. Food and Drug Administration (FDA) has approved the New Drug Application (NDA) for LISRAYA™ (brepocitinib) for the treatment of adults with dermatomyositis (DM).

Key Details:

• Drug: LISRAYA™ (brepocitinib), a first-in-class TYK2/JAK1 inhibitor.
• Indication: Approved for adults with dermatomyositis, a rare and debilitating systemic autoimmune disease.
• Significance: This is the first and only targeted therapy approved for dermatomyositis, representing a major therapeutic innovation for a condition that has lacked new treatments for decades.
• Clinical Basis: The approval is supported by data from the landmark Phase 3 VALOR trial, the largest clinical trial ever conducted for dermatomyositis.
• Commercialization: The drug is available immediately in the U.S., with patient support programs in place.

This FDA approval is a major positive catalyst for Roivant Sciences. It validates the clinical development program for brepocitinib, opens up a new revenue stream, and provides a much-needed treatment option for patients. The company will host an investor call on August 28, 2026, to discuss the update.