Novartis MS Drug Remibrutinib Misses Expectations in Key Trial Data
- Novartis AG's experimental oral multiple sclerosis drug remibrutinib reduced annualized relapse rates by 35.2% and 31.2% in late-stage trials, missing analyst expectations of a 45% to 60% reduction...
- The detailed trial results were presented at a medical conference in Toronto on Oct.
- Heinz Wiendl, co-chair of the Novartis studies, said in an interview reported by Reuters, All in all, they might be quite similar in what they do in terms...
Novartis AG’s experimental oral multiple sclerosis drug remibrutinib reduced annualized relapse rates by 35.2% and 31.2% in late-stage trials, missing analyst expectations of a 45% to 60% reduction compared with Sanofi’s Aubagio, Reuters reported on Oct. 23, 2026. Bloomberg reported that the results fell below the roughly 50% reduction expected by analysts at BNP Paribas.
Trial Data and Competitor Comparisons
The detailed trial results were presented at a medical conference in Toronto on Oct. 23, 2026, after previously being disclosed only in top-line form, according to Reuters. Bloomberg noted that the medicine is already sold as Rhapsido to treat chronic hives. The findings arrived just days after Roche Holding AG released pooled Phase III data for its rival Bruton’s tyrosine kinase inhibitor, fenebrutinib, which showed a 55% reduction in annualized relapse rates versus teriflunomide.
Novartis' MS drug remibrutinib cut relapses 35.2% and 31.2%. Analysts wanted 45-60%, and Roche's rival just posted 55%.In pharma, the bar isn't the placebo. It's the street.#Biotech #Pharma #Marketshttps://t.co/Al1An7rADO
Heinz Wiendl, co-chair of the Novartis studies, said in an interview reported by Reuters, All in all, they might be quite similar in what they do in terms of reducing relapses and disability.
Ahead of the readout, analysts stated that relapse improvements similar to Roche’s trial figures would be necessary for the new class of treatments to outperform currently utilized anti-CD20 therapies such as Ocrevus, Novartis’s Kesimpta, and TG Therapeutics’ Briumvi, which target and kill the immune cells driving multiple sclerosis.
Pipeline Stakes and Safety Profiles
Novartis is relying on the success of remibrutinib across multiple therapeutic areas following recent clinical trial setbacks for its heart drug pelacarsen and its muscle weakness therapy del-desiran. Analysts currently estimate that remibrutinib could generate more than $4 billion in peak sales if it wins regulatory approval for patients suffering from relapsing forms of multiple sclerosis, according to Reuters.
Both remibrutinib and Roche’s fenebrutinib belong to a class of treatments previously associated with liver toxicity, making safety a primary focus for observers. Reuters reported that while Roche’s fenebrutinib demonstrated an efficacy edge, it also showed significantly higher liver enzyme elevations compared to the comparator drug. Novartis stated that there was no liver safety signal observed with its drug.