Roche announced two Phase 3 successes for its BTK inhibitor in multiple sclerosis, showing efficacy in both relapsing and primary progressive forms. Company statements emphasized the drug’s potential to address unmet needs where prior BTK efforts faltered; some analysts questioned whether the data are robust enough to support approval in primary progressive MS without additional follow‑up. Roche plans regulatory submissions based on the dual registrational datasets and will address remaining safety and comparator questions in briefing packages. The wins mark a notable turnaround for the BTK class and will intensify competition among neuroimmunology pipelines.
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