Novartis AG (NVS) Announces US FDA Approval of Itvisma®

Novartis AG (NYSE:NVS) is one of the Most Undervalued Stocks to Buy Right Now. On November 24, the company announced that the US FDA approved Itvisma® (onasemnogene abeparvovec-brve) for treating children of 2 years and older, teens, and adults having spinal muscular atrophy (SMA) with a confirmed mutation in the survival motor neuron 1 (SMN1) gene. Novartis AG (NYSE:NVS) highlighted that Itvisma has been uniquely designed to address the genetic root cause of SMA with a one-time fixed dose that doesn’t require to be adjusted for age or body weight.

Novartis AG (NVS) Announces US FDA Approval of Itvisma®

By replacing the SMN1 gene, Itvisma is capable of improving motor function, providing the potential to reduce need for chronically administered treatment associated with other available therapies for this population.

In a separate release, Novartis AG (NYSE:NVS) released its Q3 2025 results, with net sales coming at US$13.9 billion, up by 8% (7% in constant currency), and volume contributing 16 percentage points to growth. Furthermore, generic competition had a negative impact of 7 percentage points due to Promacta, Tasigna, and Entresto generics in the US.

Notably, Novartis AG (NYSE:NVS)’s operating income came in at US$4.5 billion, up by 24% (27% in constant currency), thanks to the increased net sales and lower impairments, partly mitigated by increased R&D investments.

Novartis AG (NYSE:NVS) is engaged in researching, developing, manufacturing, distributing, marketing, and selling pharmaceutical medicines.

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Disclosure: None. This article is originally published at Insider Monkey.