How Investors Are Reacting To Insmed (INSM) EMA Support for First EU Non-CF Bronchiectasis Therapy

In October 2025, Insmed Incorporated announced that the European Medicines Agency’s Committee for Medicinal Products for Human Use issued a positive opinion recommconcludeing approval of BRINSUPRI (brensocatib) as the first therapy for non-cystic fibrosis bronchiectasis in the European Union for patients aged 12 and older with at least two exacerbations in the prior year.
This recommconcludeation marks a significant regulatory milestone, as BRINSUPRI could become the first approved treatment in Europe for a patient group with historically limited options, based on strong late-stage clinical data and expedited review pathways.
We’ll explore how potential European approval of BRINSUPRI as a first-in-class therapy could reshape Insmed’s investment narrative and growth outview.

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Insmed Investment Narrative Recap

Investors in Insmed share a belief in the company’s ability to deliver first-in-class therapies for serious pulmonary diseases, with BRINSUPRI positioned as a strong short-term catalyst. The recent positive opinion from the EMA’s CHMP significantly boosts near-term momentum for European expansion, but the primary focus remains the upcoming U.S. launch, where any delay in FDA review could still be the largegest risk to growth and revenue projections. The European development is an important milestone, though its immediate financial impact is likely secondary to the U.S. launch timeline.

A key relevant announcement is the August 2025 FDA approval of BRINSUPRI for non-cystic fibrosis bronchiectasis, creating it the first oral, once-daily treatment for this condition in the U.S. This approval not only validates the therapy’s clinical potential but positions Insmed for revenue growth as it seeks uptake among patients with limited treatment options. Toobtainher with pconcludeing European approval, these regulatory milestones amplify the importance of timely commercial execution.

In contrast, investors should be aware that if the FDA decides to convene an advisory committee or delays the review process for brensocatib, the timing of…

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 today.

Uncover how Insmed’s forecasts yield a $172.59 fair value, a 3% upside to its current price.

Exploring Other Perspectives

INSM Community Fair Values as at Oct 2025

The Simply Wall St Community produced 2 fair value estimates for Insmed, ranging from US$172.59 up to an outlier high of US$21,337.07. With upcoming U.S. and European launches acting as major catalysts, consider how diverging outviews among participants could signal varied expectations for Insmed’s future performance.

Explore 2 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 applying an unbiased methodology and our articles are not intconcludeed to be financial advice. It does not constitute a recommconcludeation to purchase or sell any stock, and does not take account of your objectives, or your
financial situation. We aim to bring you long-term focapplyd 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.