Roche Holdings AG (OTC:RHHBY) on Monday shared new late-breaking data from the Phase 3 FENtrepid study of the investigational Bruton’s tyrosine kinase (BTK) inhibitor fenebrutinib.

Fenebrutinib is an investigational, oral, highly selective, reversible (non-covalent) Bruton’s tyrosine kinase (BTK) inhibitor developed by Roche.

It blocks both B-cell and microglia activation, making it a candidate for treating multiple sclerosis (MS) and other autoimmune diseases by crossing the blood-brain barrier to reduce inflammation.

These data follow Roche’s announcement in November 2025 that the FENtrepid study and the first of two Phase 3 relapsing multiple sclerosis (RMS) studies (FENhance 2) met their primary endpoints.

Once the second RMS study (FENhance 1) has read out, which is expected in the first half of 2026, data from all Phase 3 fenebrutinib trials will be submitted to regulatory authorities.

Reduces Disability Progression

The trial met its primary endpoint of non-inferiority compared to Ocrevus (ocrelizumab) in reducing disability progression in patients with primary progressive multiple sclerosis (PPMS).

Fenebrutinib showed a 12% reduction in the risk of disability progression compared to Ocrevus, the only approved medicine for PPMS, as measured by the time to onset of 12-week composite confirmed disability progression (cCDP12) with curves separating as early as 24 weeks.

A consistent treatment effect on cCDP12 was observed across patient subgroups and for the entire treatment duration.

The cCDP12 primary endpoint included the confirmed disability progression (CDP) based on 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 was observed on the risk of worsening on the 9HPT by 26% compared to Ocrevus.

First Potential Scientific Breakthrough In Decade

“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,” said Levi Garraway, Roche’s Chief Medical Officer and Head of Global Product Development.

Additionally, a post-hoc analysis showed that fenebrutinib was superior to Ocrevus on a composite endpoint including two of the three components of cCDP12 (EDSS and 9HPT), with a 22% reduction in risk.

Results were shared at the Americas Committee for Treatment and Research in Multiple Sclerosis (ACTRIMS) Forum 2026.

Roche shared new Phase 3 data showing its oral MS drug fenebrutinib reduced disability progression versus Ocrevus in patients with primary progressive multiple sclerosis.

AZN Price Action: Roche shares closed higher by 1.02% at $57.70 on Friday, according to Benzinga Pro data.

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