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Novartis Gains FDA Approval for Groundbreaking SMA Gene Therapy

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Novartis Gains FDA Approval for Groundbreaking SMA Gene Therapy

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Novartis ( (NVS) ) has provided an update.

On November 24, 2025, Novartis announced that the FDA approved Itvisma, a gene replacement therapy for spinal muscular atrophy (SMA), making it the first of its kind available for children two years and older, teens, and adults. This approval marks a significant advancement in SMA treatment, offering a one-time dose that replaces the SMN1 gene, potentially reducing the need for chronic treatment. The therapy demonstrated improved motor function and stabilization in clinical trials, with a consistent safety profile. This development is expected to transform the care landscape for SMA and expand access to treatment for older patients, addressing unmet needs in the community.

The most recent analyst rating on (NVS) stock is a Buy with a $151.00 price target. To see the full list of analyst forecasts on Novartis stock, see the NVS Stock Forecast page.

Spark’s Take on NVS Stock

According to Spark, TipRanks’ AI Analyst, NVS is a Outperform.

Novartis presents a strong investment case with robust financial performance and positive earnings call highlights. The technical analysis supports a positive trend, though valuation metrics are moderate. The company’s strategic focus on innovation and expansion, despite some market challenges, underpins its growth potential.

To see Spark’s full report on NVS stock, click here.

More about Novartis

Novartis AG is a global healthcare company based in Switzerland, focusing on innovative medicines, particularly in the fields of neurology and genetic medicine. The company is known for its work in spinal muscular atrophy (SMA) and multiple sclerosis (MS), with a commitment to expanding treatment options in neuroimmunology, neurodegeneration, and neuromuscular diseases.

Average Trading Volume: 1,532,746

Technical Sentiment Signal: Buy

Current Market Cap: $242.5B

For an in-depth examination of NVS stock, go to TipRanks’ Overview page.

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