Novartis exits a BioArctic deal worth up to $802m

Novartis reported seven previously unknown tumor cases in children treated with its spinal muscular atrophy therapy, raising concerns among families and physicians. The cases were disclosed to neurologists and advocacy groups, with regulatory authorities now examining them, according to STAT.

Novartis confirmed that its gene therapy Zolgensma caused tumors in two children due to vector DNA integration, a risk still described as 'theoretical' in the FDA label. Nine tumor cases have been reported since the drug's 2019 approval. Novartis shares fell as investors reacted to the news. The company did not disclose tumor types or patient health details.

Novartis (NVS) shares declined Thursday following reports of potential safety concerns with its gene therapy Zolgensma, including nine tumor cases in treated children, according to patient advocates. The company has not yet commented on the matter.

Novartis reported seven previously unknown tumor cases in children treated with its SMA gene therapy, Zolgensma. The company stated nine tumor reports since 2019, with two potentially linked to the treatment. Regulatory authorities are examining the cases, according to SMA Europe.

Lutetium Lu 177 vipivotide tetraxetan (Pluvicto) showed real-world efficacy in mCRPC patients, with median OS of 13.1 months, consistent with prior trial data. No new safety signals were identified. The study was presented at the 2026 ESMO Congress.

A Mumbai tax tribunal ruled that Novartis's sale of Indian pharmaceutical trademarks was an outright transfer, not a royalty arrangement, involving 4.33 billion rupees ($46.06 million). The decision clarifies the distinction between trademark transfers and licensing.