Insmed shares surged after U.S. regulators approved Brinsupri, the first treatment for non-cystic fibrosis bronchiectasis.
Insmed shares got a wave of bullish calls Tuesday after U.S. regulators cleared its new drug Brinsupri, the first treatment approved for non-cystic fibrosis bronchiectasis (NCFB).
The stock jumped 8.1% on Tuesday, closing at its highest level in nearly 25 years before slipping 0.6% in after-hours trading.
The once-a-day oral medicine is approved for adults and children 12 and older, offering a new option for patients with a condition that has had no dedicated therapies until now.
NCFB is a long-term lung disease that causes permanent widening of the airways, driven by a cycle of infection, inflammation, and tissue damage. Symptoms include chronic cough, excessive mucus production, shortness of breath, and frequent infections, which can lead to exacerbations.
In the U.S., Europe, and Japan, Insmed estimates the addressed patient population at 500,000, 600,000, and 150,000 diagnosed patients, respectively.
Approval was based on late- and mid-stage data, in which Brinsupri reduced annual flare-ups by 21.1% at the 10 mg dose and 19.4% at the 25 mg dose compared to placebo. Both doses also delayed the time to the first flare.
Applications have already been filed in Europe and the U.K., with a submission in Japan planned for 2025. If cleared overseas, Insmed expects to launch in those markets starting in 2026.
Wells Fargo’s Tiago Fauth raised his price target to $140 from $130 and maintained an ‘Overweight’ rating, noting that approval had been expected, but the higher-end pricing could help the drug reach a market worth over $5 billion.
RBC Capital’s team raised its target to $138 from $120 and called the label “a best-case scenario,” noting that both doses were approved without major warnings, key trial endpoints were met, and there was no exacerbation cutoff. They see the U.S. market at $3.8 billion and the global opportunity topping $6 billion.
Meanwhile, Bank of America stuck with its $121 target and ‘Buy’ rating, saying the label contained no surprises. While approval is a major milestone, the bank said the bigger question now is whether Insmed can deliver on its own $5 billion peak sales projection.
On Stocktwits, retail sentiment for Insmed was ‘extremely bullish’ amid a 340% surge in 24-hour message volume.
One user remarked that Insmed looked like a strong long-term hold, predicting a major growth phase ahead and noting that many patients have no alternatives. They added that with minimal side effects or warnings, the drug could more easily be used for other conditions.
Another user called the FDA label “a thing of beauty,” saying it effectively doubled the addressable market for non-cystic fibrosis bronchiectasis.
They described the decision as a “grand slam” for the company, suggesting it could take off further if upcoming BiRCH trial results confirm Brinsupri’s broader potential.
Insmed’s stock has risen 76.7% so far in 2025.
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