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Novartis Reports Positive Late-stage Trial Results for Oral Multiple Sclerosis Treatment

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Novartis Reports Positive Late-stage Trial Results for Oral Multiple Sclerosis Treatment

Novartis (NOVN.SW) on Tuesday reported positive topline results from late-stage trials evaluating oral drug remibrutinib in adults with relapsing multiple sclerosis, or RMS.

The healthcare giant said the phase 3 Remodel-1 and Remodel-2 trials achieved their primary and secondary endpoints of significant reductions in annualized relapse rate and inflammatory brain lesions compared with teriflunomide. The studies also met key secondary endpoints associated with disability progression.

More than 4,500 patients participated in the remibrutinib trials across multiple indications. The highly selective, oral Bruton's tyrosine kinase inhibitor was well tolerated in the studies, Novartis said.

"We forecast $3bn un-risk-adjusted peak sales for remi, with upside potential based on exact progression data. The positive remi MS data likely increases investor conviction in remi's potential as a >$10bn asset across indications (CSU, CINDU, MS, HS data 4Q26, MG PIII FY28, Food Allergy PIII started). An anchor, large asset supports growth profile through patent cliff," analysts at BofA Global Research wrote.

Shares of the company in Switzerland rose more than 4% in midmorning trading.

The positive trial results come amid reports that the drugmaker temporarily suspended eight clinical trials for rap-cel, its experimental treatment for autoimmune and neurological disorders, after the death of three participants. The Wall Street Journal, which first reported the suspension, said US peer Bristol Myers Squibb also paused similar trials of its own CAR-T treatment as a precautionary measure.

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