Roche Multiple Sclerosis Drug Meets Main Goals in Two Late-Stage Trials

By Najat Kantouar

Roche said its fenebrutinib drug candidate met primary goals in two late-stage trials for multiple sclerosis, reducing attacks or delaying disability progression in two different forms of the disease.

The Swiss pharmaceutical group said Monday that fenebrutinib met its primary endpoint in a Phase 3 clinical trial in patients with relapsing multiple sclerosis, the most common form of the disease. It reduced the annualized relapse rate compared to a rival treatment over a period of at least 96 weeks, Roche said.

In a separate Phase 3 study in patients with primary progressive multiple sclerosis, a rarer form of the disease marked by steadily worsening symptoms without distinct relapses or periods of remission, fenebrutinib also met the primary goal, Roche said. The trial showed the drug wasn't inferior to Roche's approved treatment Ocrevus in delaying the onset of confirmed disability progression over at least 120 weeks of treatment, the company said.

Liver safety was consistent with previous studies with fenebrutinib and additional safety data is being further evaluated, Roche said.

The company said it expects to release data from a second Phase 3 trial in fenebrutinib in patients with relapsing multiple sclerosis in the first half of 2026 and then consider submitting all data to regulatory authorities.

Write to Najat Kantouar at najat.kantouar@wsj.com

(END) Dow Jones Newswires

November 10, 2025 02:05 ET (07:05 GMT)