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.

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.