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BRIDGEWATER, N.J. - The European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) has recommended approval of Insmed’s BRINSUPRI (brensocatib) for treating non-cystic fibrosis bronchiectasis (NCFB) in patients 12 years and older with two or more exacerbations in the prior year. The news comes as Insmed (NASDAQ:INSM) continues its impressive market performance, with InvestingPro data showing a remarkable 124% return over the past six months.
If approved by the European Commission, BRINSUPRI would become the first and only treatment for NCFB in the European Union. The decision is expected in the coming months. This potential approval could further boost Insmed’s strong revenue growth, which InvestingPro reports at 21.15% for the last twelve months, supported by a robust gross profit margin of 75.72%.
The CHMP opinion follows the drug’s recent approval in the United States. BRINSUPRI was reviewed under the EMA’s accelerated assessment pathway as it is considered of major public health interest and therapeutic innovation.
The recommendation is based on data from the Phase 3 ASPEN and Phase 2 WILLOW studies, both published in the New England Journal of Medicine. The drug had previously received Priority Medicines designation from the EMA.
NCFB is a chronic inflammatory lung disease characterized by permanently dilated bronchi, frequent infections, and progressive symptoms including chronic cough, excessive sputum production, and shortness of breath. Approximately 600,000 patients in the five largest European countries have been diagnosed with the condition.
"Non-cystic fibrosis bronchiectasis is a progressive disease that can lead to lung function decline," said James Chalmers, Professor at the University of Dundee and ASPEN lead study investigator, according to the company’s press release.
BRINSUPRI is a once-daily oral inhibitor of dipeptidyl peptidase 1 (DPP1), designed to reduce neutrophil-driven inflammation in the airways. The drug is also being evaluated for potential use in other neutrophil-mediated diseases.
Insmed Incorporated (NASDAQ:INSM) is a biopharmaceutical company focused on developing therapies for serious pulmonary and inflammatory conditions. With a market capitalization of $34.49 billion and trading near its 52-week high, the company shows strong momentum despite not yet achieving profitability. For deeper insights into Insmed’s financial health and growth prospects, including 13 additional ProTips and comprehensive valuation metrics, check out the detailed Pro Research Report available on InvestingPro.
In other recent news, Insmed has seen several updates from financial analysts regarding its stock price targets and ratings. UBS raised its price target for Insmed to $194 from $140, maintaining a Buy rating, citing additional indications for the company’s Brinsupri drug. Similarly, TD Cowen increased its price target to $193 from $154 after Insmed presented impressive Phase 2 data on its TPIP treatment for pulmonary arterial hypertension at the European Respiratory Society congress. Guggenheim also raised its price target to $172 from $125, following Insmed’s second-quarter 2025 results and the FDA approval of Brinsupri for non-cystic fibrosis bronchiectasis.
Morgan Stanley adjusted its price target to $144 from $126, reflecting confidence in the growth potential of Insmed’s brensocatib drug. Meanwhile, William Blair initiated coverage of Insmed with an Outperform rating, highlighting the potential for significant valuation increases driven by the clinical and commercial success of products like Brinsupri, Arikayce, and TPIP. These developments indicate a positive outlook from analysts on Insmed’s potential growth and product pipeline.
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