$IONS (IONIS PHARMACEUTICALS) — 8-K: Roche Phase 3: sefaxersen cuts proteinuria 43.1% in IgA nephropathy

Partner Roche reported late-breaking Phase 3 IMAgINATION data showing sefaxersen achieved a statistically significant 43.1% reduction in proteinuria versus placebo at 37 weeks (95% CI: 32.5-52.0, P<0.0001) in adults with primary IgA nephropathy on optimized standard of care. Treatment effects were consistent across all prespecified subgroups, and sefaxersen was well tolerated with no new safety signals. The study continues blinded to evaluate eGFR change at week 105, and Roche will share data with health authorities. Ionis is eligible for regulatory and sales milestones plus tiered royalties on net sales under its license agreement with Roche.

Partner Roche reported late-breaking Phase 3 IMAgINATION data showing sefaxersen achieved a statistically significant 43.1% reduction in proteinuria versus placebo at 37 weeks (95% CI: 32.5-52.0, P<0.