Roche Just Unleashed a Drug That Could Disrupt the Entire MS Market

This article first appeared on GuruFocus.

Roche Holding (RHHBF) could be entering a new growth chapter after unveiling strong late-stage trial data for its multiple sclerosis drug fenebrutinib. The oral BTK inhibitor sharply reduced relapse rates in patients with relapsing MS and slowed disability progression in those with the progressive form, outperforming another treatment over nearly two years. The results pushed Roche shares up as much as 2.6% on Monday before trimming gains. Vontobel analyst Stefan Schneider called the findings a positive surprise, suggesting fenebrutinib could help offset future revenue declines once Roche's key MS therapy Ocrevus starts losing patent protection in 2029.

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What makes the data stand out is fenebrutinib's potential to work across both major forms of MS relapsing and primary progressive an area where treatment options remain scarce. In a separate late-stage study targeting primary progressive MS, the drug slowed disability at a rate comparable to Ocrevus, with signs of benefit appearing within six months and lasting through the trial. If validated in upcoming readouts, fenebrutinib could become the first oral therapy to effectively address both forms of the disease, offering Roche a meaningful competitive edge in the neurology market.

Roche reported no new safety concerns, saying liver function results were consistent with prior findings. The company expects additional Phase 3 data in relapsing MS during the first half of 2026 and plans to consider a regulatory submission afterward. For investors, the message is straightforward: fenebrutinib isn't just another MS drug it could be the bridge that sustains Roche's momentum once Ocrevus faces its patent cliff.

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