Otsuka Unveils Unprecedented Phase 3 VISIONARY Two-Year eGFR Results ...

Otsuka's Phase 3 VISIONARY study results show that VOYXACT (sibeprenlimab-szsi) stabilizes kidney function decline to a baseline physiologic rate over two years in adults with IgA nephropathy, achieving a significant treatment effect with a safety profile comparable to placebo. This data supports VOYXACT's position as the first FDA-approved disease-modifying therapeutic targeting APRIL inhibition in IgAN, with Otsuka advancing a supplemental Biologics License Application for traditional approval.

This Wire brief sits within Fusion42's coverage of Biotech, and 2 sources have reported it between 3 Aug 2026 and 4 Aug 2026.