SOUTH SAN FRANCISCO (dpa-AFX) - Roche (RHHBY) announced that the FDA has granted Priority Review to the company's supplemental Biologics License Application for Gazyva/Gazyvaro for the treatment of primary membranous nephropathy. The priority review is based on the positive phase III MAJESTY results.
The FDA has already granted Breakthrough Therapy Designation to Gazyva/Gazyvaro in pMN. The company noted that this is is the second indication in recent months for which the FDA has granted priority review to Gazyva/Gazyvaro, following idiopathic nephrotic syndrome in May 2026.
At last close, Roche shares were trading at 327.00 Swiss francs, down 1.12%.
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