Roche Holding AG (RHHBY) shares climbed 2.60% to $61.17, gaining $1.55, after the company reported positive Phase 3 results for sefaxersen, an experimental treatment for primary IgA nephropathy. The move came on strong midday and late-session buying, and the clinical findings reinforced the drug's development prospects for patients living with the chronic kidney condition.

Roche's Genentech division presented the new data 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 throughout the study period.

Sefaxersen Delivers 43.1% Proteinuria Reduction

After 37 weeks of treatment, patients receiving sefaxersen achieved a 43.1% reduction in proteinuria relative to placebo. Researchers measured proteinuria using the 24-hour urine protein-to-creatinine ratio, a key marker of kidney damage. The finding reached statistical significance, with a P-value below 00001 and a 95% confidence interval spanning 32.5% to 52.0%.

Lower proteinuria levels generally indicate better prospects for preserving kidney function over time. Persistent protein in the urine is a recognized driver of progressive kidney damage in IgA nephropathy, making the marker a central focus of clinical research in the condition. The study also examined hematuria, a condition involving blood in the urine among patients with kidney disease. At week 37, more patients treated with sefaxersen achieved hematuria resolution than those given a placebo. Researchers additionally observed consistent proteinuria reductions across all prespecified patient subgroups.

Favorable Safety Data and a Monthly Dosing Approach

Sefaxersen targets complement factor B in the liver to address mechanisms associated with IgA nephropathy progression. Complement activation, an inflammatory immune process, is among the pathways implicated in the kidney injury that characterizes the disease. The investigational therapy is administered as a once-monthly subcutaneous injection and supports patient self-administration. That approach could reduce treatment frequency while offering an additional option alongside existing kidney disease therapies.

Genentech reported that patients generally tolerated sefaxersen well throughout the study's initial evaluation period. Researchers identified no new safety signals compared with findings from the earlier Phase 2 study. The results 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. The measure is the standard clinical gauge of how well the kidneys filter blood. Roche also plans to share the clinical findings with health authorities as it pursues potential regulatory approval.

A High-Burden Kidney Condition

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 each year.

The disease can eventually lead to 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. Effective treatments that preserve kidney function could therefore help reduce future demand for dialysis and transplantation. IgA nephropathy has in recent years become an active focus of drug development, with approved and investigational therapies targeting different stages of the disease process.

Roche's latest clinical results add another milestone to its kidney disease research program. The ongoing trial must still establish the treatment's longer-term effects on kidney function, and the upcoming week 105 findings will provide further evidence as the company advances sefaxersen toward potential regulatory review.

Source: Blockonomi