[Ad hoc announcement pursuant ... Note

[Ad hoc announcement pursuant to Art. 53 LR] Roche’s fenebrutinib shows unprecedented positive Phase III results as the potential first and only BTK inhibitor in both relapsing and primary progressive multiple sclerosis

Roche announced positive Phase III results for fenebrutinib. The investigational drug met its primary endpoint in the FENhance 2 study for relapsing multiple sclerosis (RMS), significantly reducing relapses compared to teriflunomide. In the FENtrepid study for primary progressive multiple sclerosis (PPMS), fenebrutinib demonstrated non-inferiority to OCREVUS in slowing disability progression. These results suggest fenebrutinib could be a highly effective oral treatment for both RMS and PPMS. Fenebrutinib targets B cells and microglia, aiming to reduce inflammation and chronic damage. Liver safety noted in studies is consistent with previous findings. The readout of the second RMS study, FENhance 1, is expected in the first half of 2026. All data will then be submitted for regulatory review. Fenebrutinib's dual mechanism of action offers potential for comprehensive multiple sclerosis care.