Roche's Gazyva/Gazyvaro Meets Primary Endpoint in Rare Kidney Disease Trial

Roche reported that its Phase III MAJESTY study in primary membranous nephropathy met its primary endpoint with Gazyva/Gazyvaro. The result positions Gazyva/Gazyvaro as a potential first approved treatment for this rare kidney condition.

Primary membranous nephropathy is a rare autoimmune kidney disease, and current treatment options are limited. The outcome may support future regulatory submissions and broaden the medicine's approved indications.

The MAJESTY data could feed into regulatory discussions and potential label expansion for Gazyva/Gazyvaro, although timing and outcomes remain uncertain. The positive MAJESTY readout supports the company's focus on specialty medicines and could add a new indication for Gazyva/Gazyvaro if regulators approve it.

Separately, the company expects its agreement with the U.S. government will keep its medicines exempt from the current round of import tariffs, but its diagnostics division remains exposed and could face renewed duties after an initial 150-day period. Roche was one of nine major pharmaceutical companies that agreed a deal with U.S. President Donald Trump in December to cut the prices of their medicines in return for removing the threat of tariffs for three years.

The diagnostics division, which generated sales of nearly 14 billion Swiss francs in 2025, exported a large share of its tests and instruments from Switzerland and other European countries to the United States. The company also produced diagnostics products in the U.S., which faced import tariffs from China. Because China has introduced retaliatory tariffs, the company ends up, as a U.S. net exporter, paying tariffs twice.

The company had no plans to split off its diagnostics division.