Roche fenebrutinib hits phase 3 goal in primary progressive MS

What happened

Roche said its experimental multiple sclerosis drug fenebrutinib met the main objective in a Phase III trial in primary progressive multiple sclerosis (PPMS). In the study, fenebrutinib reduced the risk of disability progression by 12% versus Roche’s current PPMS standard, Ocrevus, with separation showing after 24 weeks. Roche said it plans to pursue approval after additional Phase III data from an ongoing relapsing MS study expected in the 1st half of 2026.

Why markets care

PPMS has limited treatment options and progression is hard to slow, so a positive Phase III readout can reshape expectations for the MS competitive landscape and raise the bar for pipeline assets in neuro-immunology.

Winners

BTK and neuro-immun ...