[Ad hoc announcement pursuant ... Note

[Ad hoc announcement pursuant to Art. 53 LR] Roche's fenebrutinib confirms its potential as first and only BTK inhibitor for relapsing and primary progressive MS in third positive Phase III study (FENhance 1)

Roche announced positive results from the FENhance 1 Phase III study of fenebrutinib in relapsing multiple sclerosis (RMS). Fenebrutinib significantly reduced relapses by 51% compared to teriflunomide, mirroring the FENhance 2 study's 59% reduction. These results, alongside FENtrepid data in primary progressive MS, will be submitted to regulators. Fenebrutinib, a BTK inhibitor, aims to be the first high-efficacy oral treatment for both RMS and PPMS. The drug targets B cells and microglia to address both acute inflammation and chronic damage. Secondary endpoints in both RMS studies showed significant reductions in brain lesions, and progression endpoints showed favorable trends. Full data will be presented at the AAN Annual Meeting 2026. The therapy has shown a favorable safety profile, with liver transaminase elevations similar to teriflunomide. The studies involved over 1,400 RMS patients comparing fenebrutinib to teriflunomide, with the primary endpoint being the annualised relapse rate.