Context: Fenebrutinib targets BTK with brain-penetrant properties, aiming to slow disability progression by addressing mechanisms in both relapsing and progressive MS.

Results were presented at ACTRIMS Forum 2026 in San Diego, following earlier announcements that FENtrepid and FENhance 2 met primary endpoints.

The strongest observed effect was on upper limb function (9HPT), with a 26% risk reduction (HR 0.74; 95% CI 0.56–0.98), suggesting preservation of independence and daily functioning.

Fenebrutinib, an oral BTK inhibitor, met the Phase III primary endpoint in PPMS by showing non-inferiority to Ocrevus in slowing disability progression in the FENtrepid study, with a 12% relative risk reduction and earlier separation of curves at about six months.

The treatment demonstrated consistent clinical benefit across subgroups and throughout the trial, potentially offering an oral, brain-penetrant option that targets both relapsing inflammation and progressive MS biology.

Functional outcomes were assessed with established measures, including the Timed 25-Foot Walk and Nine Hole Peg Test, indicating improvements in motor function and manual dexterity.

A 26% reduction in risk for worsening on the 9HPT was a notable finding, reinforcing potential benefits in fine motor control.

The PPMS patient cohort reflects a large Phase III study population, with Roche confirming the findings in a media release dated February 7, 2026.

The Phase III program includes FENtrepid in PPMS and two RMS trials (FENhance 1 and 2); regulatory submissions are planned after the FENhance 1 RMS readout in early 2026.

Overall, data from all Phase III fenebrutinib trials are intended for regulatory submission following the FENhance 1 readout.

Regulatory submissions for PPMS and RMS are planned after the FENhance 1 RMS readout, expected in the first half of 2026.

The benefit was particularly evident in preserving upper limb function, including hands and arms.