Could Remibrutinib Become the Next $9 Billion Drug for Novartis?

Novartis AG (NYSE:NVS) has reported the first major success from three closely watched pipeline programs expected to produce clinical data in 2026. Its oral drug remibrutinib outperformed Sanofi’s older multiple-sclerosis treatment teriflunomide in reducing relapses across two late-stage studies.

The results strengthen remibrutinib’s case as a potential growth driver while Novartis faces generic pressure on its blockbuster heart-failure medicine Entresto. Analysts estimate that remibrutinib could generate as much as $9 billion in peak annual sales across all indications if its development programs succeed.

Bull Case

The two late-stage studies, REMODEL-1 and REMODEL-2, compared remibrutinib with teriflunomide in adults with a form of multiple sclerosis. Teriflunomide is marketed by Sanofi under the Aubagio brand. Remibrutinib achieved the primary objective of the studies by outperforming teriflunomide in reducing relapses. Novartis also reported clinically meaningful results in slowing the progression of disability compared with the older drug. The combination of relapse prevention and an effect on disability progression strengthens the clinical argument for remibrutinib. UBS analyst Matt Weston described it as potentially a best-in-class oral treatment, citing its efficacy and improved liver-safety profile.

Safety is particularly important for this drug class. Remibrutinib is a Bruton’s tyrosine kinase inhibitor, which works by blocking inflammatory immune cells, and earlier BTK inhibitors have encountered regulatory problems involving liver toxicity. Novartis said remibrutinib was well tolerated and showed no liver-safety issues, which was consistent with previous studies. Full results have not yet been presented, but the company’s initial disclosure could help distinguish the drug from other members of the class that have faced safety concerns.

Novartis plans to submit remibrutinib for regulatory approval globally and will present the complete study results at a medical conference in Toronto. The company already has commercial experience with the medicine, as remibrutinib is approved for one chronic inflammatory skin condition involving severe hives and is sold as Rhapsido. It generated $64 million in second-quarter sales. The drug is also being evaluated in another skin disease and food allergies, and these additional programs underpin analysts’ estimate of up to $9 billion in peak annual sales across all indications.

Bear Case

It was reported that two patients died during the studies, and although analysts said the deaths were unrelated to treatment, they still intend to examine the detailed safety data. The absence of reported liver-safety issues is encouraging, although regulators will conduct their own review of the complete evidence. Remibrutinib is not yet approved for multiple sclerosis. Novartis intends to seek global authorizations, but successful trials do not guarantee approval, favorable labeling, or commercial adoption.

The $9 billion peak-sales estimate also covers every potential indication and assumes successful development. Remibrutinib currently has approval for only one skin condition, while its multiple-sclerosis, additional skin-disease, and food-allergy opportunities remain dependent on further clinical or regulatory progress.

The wider pipeline expectations are similarly ambitious. Remibrutinib, pelacarsen, and del-desiran are collectively seen generating more than $10 billion in peak annual sales. Novartis needs these programs to support longer-term growth as generic competition pressures Entresto, but remibrutinib is only the first of the three to report its closely watched 2026 results.

Conclusion

Remibrutinib’s late-stage success gives Novartis a credible potential growth driver in a disease affecting an estimated 1.8 million people worldwide. Its reported relapse benefit, disability findings, and absence of liver-safety issues support the bullish case.

Remibrutinib may eventually become an important oral multiple-sclerosis treatment, but the $9 billion opportunity depends on approvals and successful development across several indications, and not headline results alone.

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This article is originally published at Insider Monkey.