NVS

Novartis received FDA approval for Rhapsido (remibrutinib) for symptomatic dermographism (SD), making it the only prescription treatment approved for both CSU and SD, the two most common forms of chronic hives. The approval was supported by phase III RemIND trial data showing 29.3% complete hive resolution at week 12 versus 14% for placebo.

The company is also evaluating remibrutinib in multiple sclerosis, hidradenitis suppurativa, and food allergy. However, Novartis faces pipeline setbacks with failed trials for pelacarsen and del-desiran, and generic competition pressuring blockbuster drugs.

Novartis will present Phase III REMODEL-1/-2 trial results for remibrutinib, an oral BTK inhibitor for relapsing multiple sclerosis, at MSToronto2026. The company will also showcase expanded evidence for Kesimpta (ofatumumab) across multiple studies including pediatric MS, treatment-naive patients, and pregnancy/breastfeeding outcomes. An investor call will follow the remibrutinib data presentation.

Novartis entered into a licensing agreement with Abogen Biosciences to acquire exclusive worldwide rights to ABO2203, an mRNA-encoded T-cell engager for autoimmune diseases. The deal includes a $575 million upfront payment and up to $7.2 billion in milestone payments. This move aims to strengthen Novartis' immunology pipeline following recent clinical setbacks in pelacarsen and del-desiran programs.