Roche submits multiple sclerosis drug fenebrutinib to regulators despite patient deaths

Roche said it is submitting fenebrutinib to global regulators after the experimental multiple sclerosis drug met late-stage trial goals. However, the company also disclosed that seven patients died during the studies, adding a safety overhang to the regulatory filing. The readout is constructive for Roche’s neurology pipeline, but the mortality disclosure may temper investor enthusiasm.

Analysis

Roche said it is submitting fenebrutinib to global regulators after the experimental multiple sclerosis drug met late-stage trial goals. However, the company also disclosed that seven patients died during the studies, adding a safety overhang to the regulatory filing. The readout is constructive for Roche’s neurology pipeline, but the mortality disclosure may temper investor enthusiasm.