TLDR Roche stock jumps 2.60% as Phase 3 kidney drug results boost market momentum. Sefaxersen cuts proteinuria by 43.1% in a pivotal Phase 3 IgA nephropathy trial. Phase 3 data show no new sa
Roche Holding AG reported positive Phase 3 results for its experimental kidney disease treatment, sefaxersen, showing significant reductions in proteinuria. Roche Holding AG (RHHBY) stock climbed 2.60% to $61.17, gaining $1.55 following strong midday and late-session buying. Meanwhile, the clinical findings strengthened the drug’s development prospects for patients with primary IgA nephropathy.
Roche’s Genentech division presented new findings from the ongoing Phase 3 IMAgINATION study at ASN Kidney Week 2026. The trial evaluated sefaxersen in adults with primary IgA nephropathy who continued receiving optimized standard treatment. Results showed a 43.1% reduction in proteinuria relative to placebo after 37 weeks of treatment.
Researchers measured proteinuria through the 24-hour urine protein-to-creatinine ratio, a key marker of kidney damage. Moreover, the results reached statistical significance with a P-value below 0.0001 and a 95% confidence interval of 32.5%–52.0%. Lower proteinuria levels generally indicate better prospects for preserving kidney function over time.
The study also examined hematuria, a condition involving blood in the urine among patients with kidney disease. At week 37, more patients receiving sefaxersen achieved hematuria resolution than those receiving placebo. Additionally, researchers observed consistent proteinuria reductions across all prespecified patient subgroups.
Sefaxersen targets complement factor B in the liver to address mechanisms associated with IgA nephropathy progression. The investigational treatment uses a once-monthly subcutaneous injection and supports patient self-administration. This approach could reduce treatment frequency while offering another option alongside existing kidney disease therapies.
Genentech reported that patients generally tolerated sefaxersen well throughout the study’s initial evaluation period. Furthermore, researchers identified no new safety signals compared with findings from the earlier Phase 2 study. These findings support continued clinical development, although regulators have not yet approved the treatment.
The IMAgINATION study will continue under blinded conditions to assess longer-term changes in kidney function. Researchers will measure estimated glomerular filtration rate at week 105, covering approximately two years of treatment. Roche also plans to share clinical findings with health authorities as it pursues potential regulatory approval.
Primary IgA nephropathy, also called Berger’s disease, causes progressive inflammation and damage within the kidneys’ filtering structures. The disease commonly affects younger adults, and doctors typically diagnose patients before age 40. Globally, at least 25 adults per million develop the condition annually.
The disease can eventually cause kidney failure, creating substantial long-term treatment needs for affected patients. Up to 50% of patients develop end-stage kidney disease within 20 years of diagnosis. Consequently, effective treatments that preserve kidney function could help reduce future dialysis and transplantation requirements.
Roche’s latest clinical results add another development milestone to its kidney disease research program. However, the ongoing trial must still establish the treatment’s longer-term effects on kidney function. The upcoming week 105 findings will provide further evidence as Roche advances sefaxersen toward potential regulatory review.
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