OTSUKA PHARMACEUTICAL DEVELOPMENT & COMMERCIALIZATION, INC.

Otsuka plans to submit a Biologics License Application for sibeprenlimab, an investigational monoclonal antibody for IgA nephropathy, in the first half of 2025, following positive interim analysis results from the Phase 3 VISIONARY study.

Otsuka's Phase 3 VISIONARY trial of sibeprenlimab for IgA nephropathy met its primary endpoint, showing significant reduction in 24-hour uPCR after nine months, with a favorable safety profile. The study continues to evaluate long-term kidney function, with final results expected in early 2026.