Otsuka Unveils Unprecedented Phase 3 VISIONARY Two-Year eGFR Results Demonstrating VOYXACT® (sibeprenlimab-szsi) Stabilizes Kidney Function Decline to Baseline Physiologic Rate, Fundamentally Altering Disease Progression in IgA Nephropathy (IgAN)

Otsuka Unveils Unprecedented Phase 3 VISIONARY Two-Year eGFR Results Demonstrating VOYXACT® (sibeprenlimab-szsi) Stabilizes Kidney Function Decline to Baseline Physiologic Rate, Fundamentally Altering Disease Progression in IgA Nephropathy (IgAN)

Phase 3 VISIONARY study met its key secondary endpoint, showing an annualized estimated eGFR slope of +0.3 (95% CI, -0.4 to 0.9) mL/min/1.73 m²/year with sibeprenlimab versus -4.2 (95% CI, -4.9 to -3.6) mL/min/1.73 m²/year with placebo

VOYXACT is the first-and-only U.S. FDA-approved IgAN treatment to show stabilization of kidney function, with evidence of improvement, and a safety profile consistent with placebo over two years

Adds to clinical evidence confirming VOYXACT’s selective APRIL inhibition as a disease-modifying therapeutic approach that targets a key IgAN driver to halt disease progression

New findings complete the Phase 3 VISIONARY study, marking another milestone in Otsuka’s rolling submission of a supplemental Biologics License Application (sBLA) to the U.S. FDA for traditional approval of VOYXACT