Voyxact 24-month data shows kidney function improvement in IgAN, BTIG comments

Investing.com -- BTIG analysts reviewed 24-month data from the VISIONARY trial for Voyxact (sibeprenlimab) in IgA nephropathy, showing continued positive changes in estimated glomerular filtration rate through the two-year mark.

The drug demonstrated an annualized eGFR slope of +0.3 mL/min/1.73 m² per year, with a 95% confidence interval ranging from -0.4 to +0.9. This result met the KDIGO therapeutic goal of limiting progressive kidney function decline to less than 1 mL/min/1.73 m² per year.

Voyxact-treated patients showed an annualized estimated eGFR slope improvement of +0.3 mL/min/1.73m²/yr compared to -4.2 mL/min/1.73m²/yr for placebo, representing a treatment effect of +4.5 mL/min/1.73m²/yr. The difference reached statistical significance with p<0.0001.

The least squares mean change from baseline in eGFR showed Voyxact-treated patients improved by +1.3 mL/min/1.73m² versus -7.9 mL/min/1.73m² for placebo, a treatment effect of +9.2 mL/min/1.73m². This difference was also statistically significant with p<0.0001.

The company initiated a rolling supplemental Biologics License Application after receiving accelerated FDA approval in November 2025.

Otsuka reported second quarter 2026 Voyxact revenue of approximately $78 million, representing a run-rate of about $312 million. More than 2,000 new patients started treatment since launch as of June 30, 2026. The company projects fiscal year 2026 revenue of approximately $375 million for the drug's first full year on the market.

The late-breaking oral presentation occurred at GlomCon in August. IgA nephropathy patients typically receive diagnosis between ages 16 and 35 and require lifelong therapy.

You May Also Be Interested In

• Jefferies upgrades Five Below to Buy, sees path to TJX-like re-rating
• Jefferies sees a buying opportunity in this S&P 500 sector
• Freedom Broker Downgrades Holley (HLLY) to Hold