Stock Analysis

How CHMP’s Positive Opinion on BRINSUPRI May Impact Insmed’s (INSM) Future Growth Prospects

  • On October 17, 2025, Insmed Incorporated announced that the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) issued a positive opinion recommending approval of BRINSUPRI (brensocatib) for non-cystic fibrosis bronchiectasis in patients 12 years and older with frequent exacerbations.
  • If approved, BRINSUPRI would become both the first-in-class and the first authorized therapy for this condition in the European Union, reflecting a significant regulatory milestone based on data from two major clinical trials.
  • We'll now look at how this positive CHMP recommendation for BRINSUPRI could shape Insmed's investment outlook and future growth trajectory.

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Insmed Investment Narrative Recap

To be a shareholder in Insmed, you need to believe in the company’s ability to deliver first-in-class therapies for serious respiratory diseases and convert regulatory milestones into substantial revenue growth. The recent positive CHMP opinion for BRINSUPRI in Europe could help accelerate near-term commercial opportunities, but the most important short-term catalyst remains the U.S. launch, while regulatory and market access hurdles are still key risks investors should keep in mind.

Among recent announcements, the FDA approval of BRINSUPRI in August 2025 directly reinforces the European news, strengthening the product’s global credibility and potential reach. This regulatory momentum supports Insmed’s ambitions for broader adoption, but ongoing challenges around reimbursement and physician uptake could still influence how quickly the product gains traction in both U.S. and EU markets.

However, investors should be aware that potential delays in the FDA review process, especially if an advisory committee is convened, could...

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 an earnings increase of $1.21 billion from current earnings of $-913.8 million.

Uncover how Insmed's forecasts yield a $172.59 fair value, a 5% upside to its current price.

Exploring Other Perspectives

INSM Community Fair Values as at Oct 2025
INSM Community Fair Values as at Oct 2025

Four members of the Simply Wall St Community placed fair value estimates for Insmed between US$172.59 and US$21,337.07. While revenue growth potential excites many, risks like market access and payer adoption remain top concerns for the company’s near-term progress, so explore several views before deciding.

Explore 4 other fair value estimates on Insmed - why the stock might be a potential multi-bagger!

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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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