Roche Holdings AG (RHHBY) announced Monday that its experimental multiple sclerosis drug achieved something fairly remarkable: it beat the current standard of care in slowing disability progression for patients with one of the disease's most challenging forms.
The drug in question, fenebrutinib, is an oral medication that takes a different approach than most MS treatments. It's what's called a Bruton's tyrosine kinase (BTK) inhibitor—highly selective and reversible, which matters because it can cross the blood-brain barrier to target inflammation where it actually happens. The drug blocks both B-cell and microglia activation, potentially making it useful for multiple sclerosis and other autoimmune conditions.
Better Than the Only Option Available
The Phase 3 FENtrepid trial met its primary endpoint by demonstrating non-inferiority to Ocrevus (ocrelizumab) in reducing disability progression among patients with primary progressive multiple sclerosis (PPMS). But here's the interesting part: it didn't just match Ocrevus—it actually performed better.
Fenebrutinib showed a 12% reduction in the risk of disability progression compared to Ocrevus, which happens to be the only approved medicine for PPMS. The measurement used was time to onset of 12-week composite confirmed disability progression (cCDP12), and the treatment curves started separating as early as 24 weeks into the study. That's a pretty fast signal that something's working.
The treatment effect remained consistent across different patient subgroups and throughout the entire treatment duration, which suggests the benefit isn't a statistical fluke limited to certain types of patients.
How They Measured Success
The cCDP12 primary endpoint wasn't just one measurement—it combined three different assessments of disability. These included the Expanded Disability Status Scale (EDSS) for functional disability, the timed 25-foot walk (T25FW) for walking speed, and the nine-hole peg test (9HPT) for upper limb function.
The strongest treatment effect showed up in upper limb function, where fenebrutinib reduced the risk of worsening on the 9HPT by 26% compared to Ocrevus. That's particularly meaningful for patients trying to maintain independence in daily activities.
A Potential Breakthrough After Years of Waiting
"Fenebrutinib showed a consistent clinical benefit as early as week 24, notably in upper limb function, which is essential for preserving independence and daily functioning," said Professor Amit Bar-Or, Director of the Center for Neuroinflammation and Neurotherapeutics at the Perelman School of Medicine, University of Pennsylvania. "With only one disease-modifying therapy available for people with PPMS, fenebrutinib has the potential to be a high-efficacy, oral treatment option that acts directly in the brain, targeting progressive biology, and may slow disability."
Levi Garraway, Roche's Chief Medical Officer and Head of Global Product Development, put it even more plainly: "Fenebrutinib represents the first potential scientific breakthrough for the PPMS community in over a decade, demonstrating a meaningful clinical benefit in reducing disability progression in a study versus the only approved treatment in PPMS."
A post-hoc analysis added another data point: fenebrutinib proved superior to Ocrevus on a composite endpoint that included two of the three cCDP12 components (EDSS and 9HPT), showing a 22% risk reduction.
What Comes Next
Monday's data follows Roche's November 2025 announcement that the FENtrepid study and the first of two Phase 3 relapsing multiple sclerosis (RMS) studies (FENhance 2) both met their primary endpoints. The company is now waiting for results from the second RMS study (FENhance 1), expected in the first half of 2026. Once that data comes in, Roche plans to submit the complete package from all Phase 3 fenebrutinib trials to regulatory authorities.
The results were presented at the Americas Committee for Treatment and Research in Multiple Sclerosis (ACTRIMS) Forum 2026.
Price Action: Roche (RHHBY) shares closed higher by 1.02% at $57.70 on Friday.
