Novartis's gene therapy reports 9 tumors: FDA investigates cancer risk

The U.S. Food and Drug Administration is reviewing a tumor risk linked to Novartis's Zolgensma, a gene therapy for spinal muscular atrophy. Novartis said nine cases have been reported since 2019, with genetic findings tied to the treatment identified in two of them. The review matters because Zolgensma is a one-time therapy central to Novartis's gene-therapy portfolio, and any confirmed cancer signal could weigh on its use in young patients. Investors will watch whether the FDA narrows or expands its inquiry, and whether Novartis provides further detail on the nine cases.