07:16 AM EDT, 10/16/2025 (MT Newswires) -- Novartis ( NVS ) said Thursday that its phase 3 study of Fabhalta in adults with IgA nephropathy kidney disease, or IgAn, met its primary endpoint.

The achieved primary endpoint is a "statistically significant" improvement in estimated glomerular filtration rate, or eGFR, slope compared with placebo over two years, the company said, noting that eGFR is key marker of kidney function.

Another primary endpoint is proteinuria reduction at nine months as measured by UPCR, according to Novartis ( NVS ).

Novartis ( NVS ) also said Fabhalta was well tolerated during the phase 3 trial, with a safety profile consistent with previously reported data.

The company said it plans to use the trial's data to support submissions for Fabhalta in 2026.