Roche's Oral MS Hope Fenebrutinib Hits the Mark in Phase 3

Roche's oral MS hope fenebrutinib hits the mark in phase 3

Roche's oral BTK inhibitor fenebrutinib is on track for filings next year for multiple sclerosis after clearing two phase 3 trials

Roche’s MS tablet scores in late-stage studies

The drug appears effective against both “relapsing” and “primary progressive” forms of the disease, though some analysts question if Roche has collected enough data to ask for approval in the latter.

Genentech’s Fenebrutinib Shows Unprecedented Positive Phase III Results as the Potential First and Only BTK Inhibitor in Both Relapsing and Primary Progressive Multiple Sclerosis

SOUTH SAN FRANCISCO, Calif.--(BUSINESS WIRE)--Nov 10, 2025-

[Ad hoc announcement pursuant to Art. 53 LR] Roche’s fenebrutinib shows unprecedented positive Phase III results as the potential first and only BTK inhibitor in both relapsing and primary progressive multiple sclerosis

The first (FENhance 2) of two pivotal RMS studies met its primary endpoint, showing investigational fenebrutinib significantly reduced relapses compared to...

Phase III Win for Roche with B Cell & Microglia Targeting MS Treatment

Roche announced this week that two important Phase III studies of its oral drug fenebrutinib for treatment of multiple sclerosis (MS) met their primary endpoints. Fenebrutinib is a Bruton’s tyrosine kinase (BTK) inhibitor, a class of drugs currently only approved to treat different forms of the blood cancers leukemia and lymphoma but also being developed by several companies such as Novartis, Sanofi, and Roche to treat MS. BTK inhibitors can cro…

Genentech's Fenebrutinib Shows Unprecedented Positive Phase III Results ...