TLDR
- Novartis stock rose nearly 5% after its oral MS drug remibrutinib met the main goals of two late-stage trials
- Remibrutinib beat teriflunomide (Sanofi’s Aubagio) in reducing relapse rates in relapsing multiple sclerosis patients
- The drug also showed meaningful improvement in slowing disability progression with no liver safety concerns
- Novartis paused eight trials of a separate experimental cell therapy, rap-cel, after three patient deaths due to a severe immune reaction
- Cancer trials were not affected by the rap-cel halt; Novartis plans to seek global regulatory approval for remibrutinib
Novartis stock jumped nearly 5% in early Tuesday trading after the company reported strong results from two late-stage trials of its oral multiple sclerosis drug, remibrutinib.
The trials, REMODEL-1 and REMODEL-2, tested remibrutinib against teriflunomide, an existing oral MS therapy sold by Sanofi under the brand name Aubagio. Remibrutinib came out ahead on the primary goals in both studies.
The drug demonstrated superiority over teriflunomide in reducing relapse rates in adult patients with relapsing multiple sclerosis (RMS). It also showed clinically meaningful improvement in slowing disability progression.
Novartis said remibrutinib was well tolerated across both trials. Importantly, no liver safety concerns were flagged, which is consistent with findings from earlier-stage studies.
Shreeram Aradhye, Novartis’s president of development and chief medical officer, pointed to an ongoing gap in treatment options. He said there is still a need for oral therapies that can deliver strong relapse prevention and slower disability progression without compromising safety.
“The positive REMODEL results underscore the potential of remibrutinib as a high-efficacy oral therapy for people living with RMS with a differentiated benefit-risk profile,” Aradhye said.
Novartis said it plans to pursue global regulatory approval for remibrutinib. Full trial results will be presented at an upcoming medical conference in Toronto.
Rap-Cel Trial Pause Clouds the Picture
On the same day as the MS win, Novartis confirmed it had paused eight clinical trials of a separate experimental therapy called rap-cel in late August. Three patients died after experiencing a severe, life-threatening immune reaction.
The halt was put in place on August 24. Novartis said the deaths were linked to a reaction in which the body’s immune system overreacts and attacks its own organs, a known risk with CAR-T therapies.
Rap-cel is a CAR-T therapy that modifies a patient’s immune cells to recognise and destroy specific target cells. The paused trials covered autoimmune diseases including lupus, rheumatoid arthritis, and vasculitis, as well as neurological conditions such as multiple sclerosis and myasthenia gravis.
Novartis said it is conducting a full review of the safety events and working with independent safety boards to understand what happened and identify ways to catch dangerous side effects earlier.
Cancer Trials Not Affected
The company confirmed its two ongoing trials in lymphoma and leukemia patients were not affected by the rap-cel pause. Novartis said it is sharing information with health authorities and continuing to monitor patients who have already received the treatment.
The Wall Street Journal first reported the trial halt. The report also noted that Bristol Myers Squibb had paused similar CAR-T trials in autoimmune disorders as a precautionary measure. Bristol did not respond to a request for comment.
Despite the rap-cel news, investors focused on the remibrutinib results. Novartis stock was trading up around 4% on Tuesday.
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