Novartis stock climbed after the Swiss drugmaker announced positive results Tuesday from two late-stage trials of its oral multiple sclerosis drug remibrutinib, raising expectations that the medicine could become a major revenue driver.
By Tuesday's European midday session, Novartis shares had gained 4.5%, pushing the stock's gain for the year to 18%, according to the Wall Street Journal .
The two Phase III studies, called REMODEL-1 and REMODEL-2, each enrolled approximately 1,000 patients with relapsing multiple sclerosis and compared remibrutinib against teriflunomide, sold by Sanofi under the brand name Aubagio. Both trials met their primary endpoint, reducing the annualized relapse rate, and showed superiority over teriflunomide across all key secondary endpoints, including a reduction in MRI brain lesions, the company said. The drug also produced clinically meaningful results in slowing disability progression.
Novartis said remibrutinib showed no liver safety signal across more than 4,500 clinical trial participants in multiple indications, with no cases meeting Hy's Law criteria. Other medicines in the BTK inhibitor category — which stands for Bruton's tyrosine kinase — have run into trouble with regulators because of liver-toxicity findings, according to Reuters . In December, the U.S. Food and Drug Administration declined to approve Sanofi's tolebrutinib after that drug failed to show superiority to Aubagio in preventing relapses.
UBS analyst Matt Weston told clients that "remi looks like it is at least a best-in-class oral agent." Weston added that remibrutinib's pairing of robust relapse control with a cleaner liver-safety record made it "a no-brainer" compared with competing drugs.
Reuters reported that two patients died during the trials, with investigators determining the deaths were unconnected to the study drug. Analysts said they would be looking for more detailed safety data.
The company intends to pursue regulatory approval for remibrutinib in relapsing multiple sclerosis across major markets, with complete trial data to be shared at an upcoming medical conference in Toronto. "Despite advances in treatment, an unmet need remains for oral therapies that can deliver robust relapse prevention, slow disability progression, while maintaining a favorable safety profile," said Shreeram Aradhye, Novartis's chief medical officer, in the company's announcement.
Remibrutinib is already approved in the U.S. and the European Union under the brand name Rhapsido for the skin condition chronic spontaneous urticaria. The company has identified remibrutinib as a key pipeline asset as it works to offset revenue lost when blockbuster heart drug Entresto faced generic competition. Multiple sclerosis drug Kesimpta grew 32% to $1.42 billion in the second quarter, underscoring the commercial potential of the MS franchise.
Among a trio of high-profile Novartis development programs expected to produce readouts this year, the REMODEL trials represent the first positive outcome. The company is also awaiting results from studies of heart drug pelacarsen and gene therapy del-desiran.
