Roche's Experimental MS Drug Fenebrutinib Shows Promise in Late-Stage Trials

Roche reported that its investigational drug fenebrutinib achieved the primary endpoint in a crucial late-stage trial for relapsing multiple sclerosis, outperforming teriflunomide. If approved, it could offer a new treatment option and generate over $1 billion in annual sales. Further data from a second trial is anticipated in 2026.

Roche's experimental drug fenebrutinib has met its main target in a key late-stage trial for relapsing multiple sclerosis (MS), according to an announcement made by the Swiss pharmaceutical company. The success of the trial fueled a nearly 2% increase in the company's shares.

The drug demonstrated a significant reduction in the annualized relapse rate compared to Sanofi's teriflunomide over a minimum of 96 weeks. Analysts from Leerink predict that fenebrutinib could exceed $1 billion in annual peak sales if greenlit by regulatory bodies.

Anticipation builds as findings from the second late-stage study are expected by the first half of 2026, despite previous enrollment halts by the U.S. FDA due to liver injury concerns. Roche underscores that liver safety aligns with earlier trials and plans to present detailed results at a forthcoming medical meeting.

(With inputs from agencies.)