Author: Nikita Shah, Beyond Neurology
The rollercoaster in the MS fairground has taken another sharp turn. Tolebrutinib has missed its primary endpoint in the Phase 3 PERSEUS trial in PPMS, and the already delayed FDA decision for its nrSPMS indication now looks likely to slip further, into 2026, marking another couple of twists on an already bumpy track.
At the same time, momentum is building elsewhere with fenebrutinib lining up on the next track. Its positive Phase 3 data in both RMS and PPMS make it a key contender as Roche prepares for potential regulatory filings in 2026, pending additional data.
What all of this means for the future of BTK inhibitors in MS is still far from clear, but anticipation continues to build. The race for first- and best-in-class feels very much alive.
The Beyond Neurology team will continue keeping a close eye on how this plays out over the coming months – we suspect there are a few more twists left yet, stay tuned!
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