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Tuesday, September 1, 2026

Remibrutinib Phase 3 MS success drives Novartis premarket surge

 

Remibrutinib Phase 3 MS success drives Novartis 4.64% premarket surge

  • Novartis announced positive REMODEL-1/2 Phase 3 results early today for oral BTK inhibitor remibrutinib in relapsing multiple sclerosis (RMS).
  • Drug met primary endpoint with significant reduction in annualized relapse rate versus Sanofi's Aubagio (teriflunomide).
  • Remibrutinib showed superiority on key secondaries including MRI lesion reduction and slowing disability progression.
  • Favorable safety profile reported with no new or increased liver safety signals observed.
  • Novartis plans to file for global regulatory approvals based on the strong data readout.
  • News matches timing of premarket move; viewed as key pipeline asset with substantial peak sales potential.

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