Roche Holding stock: FDA accepts fenebrutinib application for priority review

Roche said the FDA accepted its application for fenebrutinib under priority review. The investigational medicine is being developed for relapsing and primary progressive multiple sclerosis.

Roche said on September 30, 2026, that the U.S. Food and Drug Administration accepted its New Drug Application for fenebrutinib under priority review. The application covers the investigational non-covalent Bruton’s tyrosine kinase inhibitor in relapsing multiple sclerosis and primary progressive multiple sclerosis.

Phase III data support application

Roche said the filing is supported by the Phase III FENhance 1 and 2 studies in relapsing multiple sclerosis and the Phase III FENtrepid study in primary progressive multiple sclerosis. In the FENhance studies, fenebrutinib reduced annualized relapse rates by 51.1 percent and 58.5 percent versus teriflunomide over 96 weeks, according to the company.

Roche also said FENtrepid met its primary endpoint of non-inferiority versus Ocrevus in reducing disability progression. The company reported a 12 percent numerical reduction in the risk of progression compared with Ocrevus, measured by time to onset of 12-week composite confirmed disability progression.

The application concerns a product that remains investigational and would require FDA approval before commercialization in the covered indications.