Nipocalimab is the first and only investigational therapy granted U.S. FDA Breakthrough Therapy Designation for the treatment of adults living with moderate-to-severe Sjögren's disease
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Johnson & Johnson's investigational therapy, nipocalimab, has been granted Breakthrough Therapy Designation by the FDA for treating moderate-to-severe Sjögren's disease. This is the first therapy to receive such a designation for this condition, supported by positive Phase 2 study results.
November 11, 2024 | 9:30 pm
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Johnson & Johnson's nipocalimab has received FDA Breakthrough Therapy Designation for Sjögren's disease, indicating potential for significant advancement in treatment options for this condition.
The FDA's Breakthrough Therapy Designation for nipocalimab in treating Sjögren's disease suggests a strong potential for future approval and market success, which could positively impact JNJ's stock. The designation is based on promising Phase 2 study results, indicating a significant improvement in disease activity.
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