Novartis Halts CAR-T Autoimmune Trials After Three Patient Deaths; Shares Rise

Novartis (SIX: NOVN), the Basel-headquartered pharmaceutical group behind Entresto, Cosentyx and Kisqali, has paused eight early- and mid-stage trials of its experimental CD19-directed CAR-T cell therapy for autoimmune and neurological disorders. The move follows three patient deaths in late August, the Wall Street Journal reported on Tuesday.

Shares in Novartis traded up 5.37% in early dealing, reaching 129.88 Swiss francs and closing in on their 52-week high of 131.50 francs. The move is directionally inconsistent with the safety headline, and no second catalyst has been confirmed to explain it.

CAR-T therapy reprogrammes a patient’s own immune cells to attack a specific target, in this case one marked by the CD19 protein. The deaths resulted from a severe, cytokine-driven immune overreaction, a known but dangerous CAR-T risk, an unnamed Novartis spokesman told the Wall Street Journal. Novartis said it is reviewing the safety events with independent monitoring boards and sharing findings with regulators.

The read-through was immediate across the sector. Bristol Myers Squibb (NYSE: BMY), which is developing a similar CAR-T approach for autoimmune disease, also paused its own trials as a precaution following Novartis’s disclosure.

The setback delays, but does not necessarily end, Novartis’s push into CAR-T therapy for autoimmune disease, a pipeline bet that sits alongside its established oncology and cardiovascular franchise. The outcome of the independent safety review and any subsequent regulatory response are the next points traders in Novartis and Bristol Myers Squibb will be watching.