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Novartis Gains FDA Approval for Rhapsido® in CSU Treatment

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Novartis Gains FDA Approval for Rhapsido® in CSU Treatment

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The latest update is out from Novartis ( (NVS) ).

On September 30, 2025, Novartis announced that its drug Rhapsido® (remibrutinib) received FDA approval as the first oral Bruton’s tyrosine kinase inhibitor (BTKi) for treating chronic spontaneous urticaria (CSU) in adults who remain symptomatic despite antihistamine treatment. This approval marks a significant advancement in CSU care, offering a new oral treatment option that provides fast relief without the need for injections or lab monitoring. The approval is based on positive results from Phase III clinical trials, and it expands Novartis’s immunology portfolio, potentially impacting the lives of 1.7 million people in the US living with CSU.

The most recent analyst rating on (NVS) stock is a Sell with a $118.00 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’s strong financial performance and positive earnings call are the most significant factors driving the score. The company’s robust profitability, efficient operations, and strategic investments are complemented by a positive market outlook and shareholder-friendly initiatives like the share buyback program. However, technical indicators suggest caution due to overbought conditions, and valuation metrics indicate a fair price, balancing growth and income potential.

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

More about Novartis

Novartis is a global healthcare company based in Basel, Switzerland, primarily focused on the research, development, and manufacturing of pharmaceuticals. The company is known for its innovative treatments in various medical fields, including immunology, oncology, and neuroscience.

Average Trading Volume: 1,488,625

Technical Sentiment Signal: Buy

Current Market Cap: $236.3B

For detailed information about NVS stock, go to TipRanks’ Stock Analysis page.

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