Insmed Stock Rise on EU Nod for Lung Disease Drug, Brinsupri

Insmed INSM announced that the European Commission has approved Brinsupri (brensocatib) for the treatment of non-cystic fibrosis bronchiectasis (“NCFB”). Shares of the company were up 2.1% following the announcement of the news yesterday.

NCFB is a chronic and progressive lung disease that can lead to permanent lung damage. Brinsupri is now approved in Europe for treating NCFB in patients aged 12 years and above with two or more exacerbations in the prior 12 months.

Following the nod, Brinsupri became the first and only approved treatment to be indicated for NCFB in the European Union (“EU”). The drug was reviewed under the European Medicines Agency’s (“EMA”) accelerated assessment pathway as it is deemed to be of major interest for public health.

The FDA approved Brinsupri for the treatment of NCFB in August.

Year to date, shares of Insmed have skyrocketed 192% compared with the industry’s rise of 15.7%.

More on the Latest EU Nod for INSM’s Brinsupri

The EU approval for Brinsupri is supported by a comprehensive scientific review of the marketing application, which included data from the phase III ASPEN and the phase II WILLOW studies.

Data from the ASPEN study showed that treatment with Brinsupri (25 mg) reduced the annual exacerbation rate by 19.4% versus placebo. The study also met key secondary goals by significantly prolonging the time to first exacerbation and increasing the number of patients who remained exacerbation-free during the treatment period.

Patients who were treated with Brinsupri experienced statistically significantly less decline in lung function, as measured by forced expiratory volume in one second after using a bronchodilator, at week 52.

The approval in the EU was expected, as last month, the EMA’s Committee for Medicinal Products for Human Use (“CHMP”) recommended approving Brinsupri to treat NCFB.

Regulatory filings seeking approval for Brinsupri are currently under review in the United Kingdom and Japan.

During the third quarter of 2025, Brinsupri recorded sales worth $28.1 million in the partial quarter since its approval and launch in the United States. The drug is witnessing an early, encouraging commercial launch in the United States.

Apart from bronchiectasis, Insmed is evaluating Brinsupri in the phase IIb BiRCh study in patients with chronic rhinosinusitis without nasal polyps (CRSsNP). A data readout is expected in early 2026. The company is also evaluating the drug in the phase II CEDAR study for the hidradenitis suppurativa indication, with top-line data expected in the first half of 2026.

Insmed, Inc. Price

Insmed, Inc. price | Insmed, Inc. Quote

INSM's Zacks Rank & Stocks to Consider

Insmed currently carries a Zacks Rank #3 (Hold).

Some better-ranked stocks in the biotech sector are Alkermes ALKS, CorMedix CRMD and Castle Biosciences CSTL, each sporting a Zacks Rank #1 (Strong Buy) at present. You can see the complete list of today’s Zacks #1 Rank stocks here.

In the past 60 days, estimates for Alkermes’ 2025 earnings per share have increased from $1.82 to $1.96. Earnings per share estimates for 2026 have moved up from $1.70 to $1.77 during the same period. ALKS stock has increased 2.2% year to date.

Alkermes’ earnings beat estimates in three of the trailing four quarters and missed the mark on one occasion, delivering an average negative surprise of 4.58%.

In the past 60 days, estimates for CorMedix’s 2025 earnings per share have increased from $1.52 to $2.90. Earnings per share estimates for 2026 have moved up from $2.09 to $2.72 during the same period. CRMD stock has surged 24.4% year to date.

CorMedix’s earnings beat estimates in each of the trailing four quarters, with an average surprise of 27.04%.

In the past 60 days, estimates for Castle Biosciences’ 2025 loss per share have narrowed from 65 cents to 23 cents. Loss per share estimates for 2026 have narrowed from $2.10 to $1.42 during the same period. CSTL stock has rallied 26% year to date.

Castle Biosciences’ earnings beat estimates in three of the trailing four quarters, while missing the same on the remaining occasion, with an average surprise of 66.11%.

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