Novartis (SWX:NOVN) Is Up 6.1% After FDA Approval for Rhapsido and Cosentyx Pricing Shift – What’s Changed

• In September 2025, Novartis announced US FDA approval for Rhapsido (remibrutinib), the first oral Bruton's tyrosine kinase inhibitor for chronic spontaneous urticaria, and revealed plans to launch a direct-to-patient platform offering Cosentyx at a 55% discount for cash-paying Americans.
• The FDA approval introduces a novel, convenient treatment option for patients unresponsive to antihistamines, while the Cosentyx direct-to-patient initiative marks a shift in drug pricing and access strategies within the US pharmaceutical market.
• We'll explore how the launch of a direct-to-patient Cosentyx platform could influence Novartis' growth and competitive position.

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Novartis Investment Narrative Recap

To be a shareholder in Novartis, you need to have confidence in its ability to maintain branded drug strength and pipeline momentum while adapting to changing drug pricing models and competitive threats. Recent FDA approval of Rhapsido and the launch of a discounted direct-to-patient Cosentyx platform bring new treatment options and commercial strategies, but do not shift the company’s most important short-term catalyst: sustaining growth in key innovative brands amid intensifying pricing and generic pressures. The risk of fast-tracked generic competition, especially for blockbusters losing exclusivity, remains the most material challenge.

Among recent announcements, the positive pivotal data and label expansion for Kesimpta in multiple sclerosis is particularly relevant. This supports Novartis’ focus on fast-growing neurologic and immunology franchises, which are critical as the company faces pricing headwinds and prepares for possible generic entry impacting older core products. Yet, while new launches and expanded indications could drive growth, the ability to defend market share and pricing for established medicines remains under pressure...

Read the full narrative on Novartis (it's free!)

Novartis' outlook forecasts $59.1 billion in revenue and $17.3 billion in earnings by 2028. This is based on an assumed annual revenue growth rate of 2.3% and a $3.6 billion increase in earnings from the current $13.7 billion.

Uncover how Novartis' forecasts yield a CHF99.08 fair value, a 5% downside to its current price.

Exploring Other Perspectives

Seven Simply Wall St Community fair value estimates range from US$99 to US$270 per share, with nearly threefold variation. With loss of exclusivity posing an ongoing earnings threat, you might want to see how other investors account for long-term generic risk.

Explore 7 other fair value estimates on Novartis - why the stock might be worth just CHF99.08!

Build Your Own Novartis Narrative

Disagree with existing narratives? Create your own in under 3 minutes - extraordinary investment returns rarely come from following the herd.

• A great starting point for your Novartis research is our analysis highlighting 5 key rewards and 1 important warning sign that could impact your investment decision.
• Our free Novartis research report provides a comprehensive fundamental analysis summarized in a single visual - the Snowflake - making it easy to evaluate Novartis' overall financial health at a glance.

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This article by Simply Wall St is general in nature. We provide commentary based on historical data and analyst forecasts only using an unbiased methodology and our articles are not intended to be financial advice. It does not constitute a recommendation to buy or sell any stock, and does not take account of your objectives, or your financial situation. We aim to bring you long-term focused analysis driven by fundamental data. Note that our analysis may not factor in the latest price-sensitive company announcements or qualitative material. Simply Wall St has no position in any stocks mentioned.

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