Novartis (NVS)’s Cell Therapy Promise Meets a Safety Challenge

Novartis and Bristol Myers Squibb paused autoimmune CAR-T trials due to safety concerns. Novartis halted eight studies of Rap-cel after three fatal cases, while BMS paused Zola-cel trials due to reversible inflammatory events. Novartis also entered a $3.223B deal with Alteogen for subcutaneous biologics. RedHill acquired Rebyota and Clenpiq from Ferring for $12M upfront. Experts argue for real-world insights in obesity care strategy.

Novartis and Bristol Myers Squibb have paused trials of their CAR-T cell therapies for autoimmune disorders due to safety concerns. Novartis reported fatal outcomes in three trials of Rap-cel, while Bristol Myers noted reversible inflammatory events in Zola-cel trials. Both companies are reviewing data and engaging with regulators. Analysts suggest faster manufacturing processes may be linked to the issues, affecting multiple biotech companies' stocks.

Novartis NVS reported positive late-stage trial results for remibrutinib in relapsing multiple sclerosis (RMS), meeting primary endpoints and showing significant reductions in annualized relapse rate versus Aubagio. The studies involved 2,000 patients and demonstrated favorable safety and efficacy. Shares rose 6% on the news. Novartis plans regulatory submissions and further presentations. Remibrutinib is also approved for chronic spontaneous urticaria (CSU) under the brand Rhapsido, with $101M

Novartis (NYSE: NVS) signed a $3.22B licensing deal with Alteogen for biologic medicines. The company offers a 2.94% dividend yield, but its stock is 23.7% overvalued according to GF Value™. Novartis has a GF Score™ of 82, indicating strong financial health. Institutional interest is mixed, with some gurus adding and others trimming positions.

Novartis reported that remibrutinib met primary endpoints in two Phase III trials for relapsing multiple sclerosis, showing reduced relapse rates and MRI lesions. The drug also demonstrated a favorable safety profile. Novartis plans to seek global regulatory approval and present detailed results at MSToronto2026. Remibrutinib is already approved for chronic spontaneous urticaria.

Alteogen (196170.KQ) and Novartis (NVS) agreed to develop and commercialize subcutaneous products using Alteogen's Hybrozyme technology. Novartis may pay up to $3.223B if all options are exercised, including milestone payments and royalties. NVS stock is currently at $161.98, up 0.45%.