Roche's Sefaxersen Cuts Proteinuria 43.1% in Phase III IgA Nephropathy Trial

Roche (RHHBY) reported late-breaking Phase III data showing its investigational therapy sefaxersen produced a statistically significant and clinically meaningful reduction in proteinuria in adults with primary IgA nephropathy (IgAN) on optimized standard of care. Results from the ongoing IMAgINATION study, presented at the American Society of Nephrology Kidney Week 2026, showed patients achieved a 43.1% reduction in proteinuria versus placebo at Week 37, measured by 24-hour urine protein-to-creatinine ratio (UPCR), the primary endpoint. Among patients with baseline haematuria, a greater proportion on sefaxersen achieved resolution by Week 37 compared with placebo. Roche said benefits were consistent across all prespecified subgroups, and the drug was well tolerated with no new safety signals. Sefaxersen is an investigational once-monthly subcutaneous injection designed for self-administration. The trial continues in a blinded phase, with a key secondary endpoint assessing eGFR change at Week 105. Roche licensed development and commercialization rights from Ionis Pharmaceuticals. RHHBY closed Friday's regular trading at $61.17, up $1.55, or 2.60%.