Novartis's Remibrutinib Beats Sanofi's Aubagio in Two Late-Stage MS Trials

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Summary · why it matters

Novartis's oral drug remibrutinib outperformed Sanofi's older multiple-sclerosis treatment teriflunomide in reducing relapses across two late-stage studies, REMODEL-1 and REMODEL-2, marking the first major success from three closely watched pipeline programs expected to produce clinical data in 2026. Novartis said remibrutinib also showed clinically meaningful results in slowing disability progression and was well tolerated with no liver-safety issues, a key point for a Bruton's tyrosine kinase inhibitor, a class that has previously faced regulatory problems over liver toxicity. UBS analyst Matt Weston called it potentially a best-in-class oral treatment. Novartis plans to submit remibrutinib for global regulatory approval and will present full results at a medical conference in Toronto; the drug is already approved for one chronic inflammatory skin condition involving severe hives, sold as Rhapsido, which generated $64 million in second-quarter sales. Analysts estimate remibrutinib could generate as much as $9 billion in peak annual sales across all indications, though that figure assumes successful development and approvals in multiple sclerosis, additional skin disease, and food allergies, and two patients died during the studies, which analysts said were unrelated to treatment but still intend to examine in the detailed safety data. Remibrutinib is the first of three programs, alongside pelacarsen and del-desiran, collectively seen generating more than $10 billion in peak annual sales as Novartis faces generic pressure on its blockbuster heart-failure medicine Entresto.

Impact on assets 3

Biotech & Genomic Medicine▲
Novartis AG
NOVN
▲ PositiveTechnologyrelevance

Remibrutinib beat Sanofi's Aubagio in two late-stage MS trials, showing best-in-class potential and supporting a global regulatory submission.

Health Care▼
Sanofi SA
SAN
▼ NegativeCompetitionrelevance

Sanofi's older MS drug teriflunomide (Aubagio) was outperformed by Novartis's remibrutinib in two late-stage trials, a competitive loss.

Financials▲

Theme Impact 1

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