Novartis confirmed additional tumor reports in children treated with its spinal muscular atrophy gene therapy Zolgensma (onasemnogene abeparvovec-xioi). The company disclosed nine reports total, including seven newly reported cases, and stated that two cases show evidence of AAV vector DNA integration into patient DNA. Novartis said it has notified health authorities and will continue to work with them on next steps, emphasizing patient safety. The prescribing information already includes a “theoretical risk” of tumorigenicity due to AAV integration, and the new disclosures keep the gene-therapy safety signal in focus for regulators, clinicians, and investors. The update also renews scrutiny of vector integration monitoring strategies across AAV-based programs, particularly where long-term follow-up data are still maturing.