Novartis and Bristol Myers halt autoimmune CAR-T trials after inflammatory side effects emerge
AI Market Summary
Novartis and Bristol Myers paused multiple autoimmune CAR-T trials after inflammatory safety signals, including cases of IEC-HS, raising regulatory and development-risk concerns for the autoimmune cell-therapy theme. While oncology programs continue, the holds may delay timelines and increase uncertainty around risk/benefit profiles and eventual adoption. The news is most directly negative for Novartis' immunology pipeline visibility and broader sentiment toward autoimmune CAR-T developers.
Impact level
● Medium
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▼ Bearish
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Novartis has stopped development of its CAR-T therapy rap-cel across multiple indications after side effects were observed during testing. Bristol Myers Squibb has also voluntarily paused its zola-cel program over safety concerns. Results published in February reported one case of IEC-HS in a Phase 1 study of zola-cel. Kyverna Therapeutics could file for approval in stiff person syndrome by year-end and is enrolling patients for a pivotal myasthenia gravis study.
