Insmed (INSM) Is Up 9.3% After FDA Approves First-Ever NCFB Therapy for Adults and Teens

• On August 12, 2025, Insmed announced that the U.S. FDA approved BRINSUPRI™ (brensocatib), making it the first and only therapy for non-cystic fibrosis bronchiectasis (NCFB) in adults and children over 12.
• This milestone addresses a significant unmet clinical need and sets the stage for Insmed’s broader expansion into respiratory disease markets worldwide.
• We'll examine how the first-ever FDA approval for NCFB therapy transforms Insmed’s investment narrative and growth outlook.

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Insmed Investment Narrative Recap

To be a shareholder in Insmed today, you need to believe in the potential for BRINSUPRI™ (brensocatib) to transform the treatment landscape for non-cystic fibrosis bronchiectasis, driving substantial new revenue streams. The recent FDA approval directly addresses the chief short-term catalyst, the US launch of brensocatib, and largely removes the regulatory delay risk, refocusing attention on the pace of commercial uptake and payer acceptance as the next critical hurdles.

Among the latest announcements, Insmed’s reiterated global ARIKAYCE revenue guidance for 2025, projecting US$405 million to US$425 million, stands out. While the revenue outlook remains unchanged for this existing product line, investor attention now shifts to how quickly brensocatib uptake could influence growth trajectories and financial results from late 2025 onward. But while the regulatory milestone is cleared, investors should note that...

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

Insmed's narrative projects $1.9 billion revenue and $293.8 million earnings by 2028. This requires 72.0% yearly revenue growth and a $1,207.6 million increase in earnings from -$913.8 million.

Uncover how Insmed's forecasts yield a $120.12 fair value, in line with its current price.

Exploring Other Perspectives

Three Simply Wall St Community valuations range from US$120 to over US$21,000 per share, showing sharply differing outlooks. Fast market access and payer adoption will be critical to how the company’s real-world growth plays out, so it’s worth exploring how others weigh these possibilities and their implications for future performance.

Explore 3 other fair value estimates on Insmed - why the stock might be worth just $120.12!

Build Your Own Insmed 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 Insmed research is our analysis highlighting 2 key rewards and 2 important warning signs that could impact your investment decision.
• Our free Insmed research report provides a comprehensive fundamental analysis summarized in a single visual - the Snowflake - making it easy to evaluate Insmed's 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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