Novartis Signs $3.22bn Alteogen SC Drug Delivery Deal

Novartis halted clinical trials for its CAR T therapy rapcabtagene autoleucel after three patient deaths due to severe immune reactions. Bristol Myers Squibb also paused trials for its competitor product zola-cel, citing reversible inflammatory events. Both therapies target CD19, a protein linked to immune responses, but can cause severe immune reactions. Neither company has identified a cause.

Novartis has secured exclusive rights to develop and commercialize subcutaneous versions of several products using Alteogen’s ALT-B4 technology. The deal could be worth up to $3.223 billion plus royalties if all options and milestones are met. This technology could potentially be used across multiple products, helping Novartis prepare for patent losses on major medicines. Alteogen has also signed similar deals with Biogen and GSK’s Tesaro. Novartis is also investing in other delivery technologie

Novartis halted eight clinical trials of its experimental cell therapy rap-cel after three patients died from severe immune reactions. The pause affects trials for autoimmune and neurological disorders. Novartis is reviewing the deaths and sharing information with health authorities. Bristol Myers also paused studies of its rival CAR T-cell treatment zola-cel. Novartis shares rose 4% on Tuesday.

Novartis reported that remibrutinib, an oral BTK inhibitor, significantly reduced relapse rates compared to teriflunomide in two Phase 3 trials for relapsing multiple sclerosis, with no liver safety signals. Full data, including relapse rates and adverse events, will be presented in October 2026. The drug is not yet approved for MS.

Novartis (NYSE: NVS) has agreed to pay up to $3 billion for licensing options to Alteogen's Hybrozyme drug-delivery platform, which enhances the absorption of biologics. The deal includes option fees, milestones, and royalties, with Novartis aiming to convert IV infusions into subcutaneous injections. Novartis shares are at $162.46, with a market cap of $308.79 billion. The company sees this as a way to defend against biosimilars and improve patient convenience.

Novartis reported positive phase 3 trial results for remibrutinib, showing superiority over teriflunomide in reducing relapse rates and brain lesions in relapsing multiple sclerosis. The drug demonstrated safety and efficacy in key endpoints. Novartis aims to address unmet needs in oral therapies for RMS. (NVS)