Novartis, CH0012005267

Novartis stock faces FDA probe over Zolgensma tumor risk

Published on 11/09/2026 at 18:11 | Editorial responsibility: Rafael Müller, Editor-in-Chief AD HOC NEWS

Novartis stock faces fresh scrutiny as the FDA investigates tumor reports linked to Zolgensma. The agency still backs the therapy's benefits.

FDA Review Raises Safety Questions

The FDA is investigating malignancy reports linked to Novartis' Zolgensma gene therapy.
The agency says the approved benefits of Zolgensma and Itvisma still outweigh their potential risks.
Further regulatory guidance and case information may shape investor views on the therapy's outlook.

Novartis, CH0012005267, Illustration mit AI erstellt.

Novartis faces fresh regulatory scrutiny after the US Food and Drug Administration opened an investigation into a potential malignancy risk linked to Zolgensma. The FDA published its safety communication on Friday, November 6, while Novartis had disclosed nine tumor reports among patients treated with the gene therapy since its 2019 approval.

In two cases, investigators found evidence that DNA from the viral carrier had integrated into the patients' DNA. The FDA said the reports include tumors affecting the central and peripheral nervous systems, spinal and paraspinal areas, and the kidney. Zolgensma is used for children under two with spinal muscular atrophy.

Benefit-Risk Balance Remains Central

The FDA said the overall benefits of Zolgensma and Itvisma continue to outweigh their potential risks for approved uses. Itvisma uses the same vector and construct, but the agency said no neoplasia cases had been reported after its administration. The regulator is assessing whether further action, updated prescribing information or changes to long-term follow-up studies are needed.

Novartis said the potential tumor risk is already included in Zolgensma's prescribing information and that it is conducting long-term safety follow-up. The FDA recommends monitoring patients and clinical trial participants for tumor formation. The review therefore adds a regulatory risk to the product outlook, but does not itself announce a change to the approved use.

What Has Changed Since The Latest Report

The latest relevant report on Monday, November 9, cited a Lang & Schwarz quote of 146.83 euros at 12:12:51 CET. Novartis stock traded at 145.17 euros on Lang & Schwarz at 18:06:55 CET on Monday, November 9, 2026, 1.13 percent below that earlier quote. This intraday move is separate from the Xetra daily comparison.