Company Overview Insmed operates as a specialized biopharmaceutical company focused on rare and serious respiratory diseases, and the company just achieved a landmark milestone that could transform its trajectory. On August 12, 2025, the FDA approved BRINSUPRI (brensocatib) as the first and only treatment for non-cystic fibrosis bronchiectasis in adults and children 12 years and older. The drug launched commercially in the U.S. immediately following approval and is now available through specialty pharmacy networks.
What makes Insmed particularly compelling right now is the magnitude of the commercial opportunity unfolding in real-time. Approximately 500,000 U.S. patients have been diagnosed with bronchiectasis—a serious, chronic lung disease marked by frequent pulmonary exacerbations—and until BRINSUPRI’s approval, there were zero approved therapies specifically targeting this condition. Analysts at Mizuho project the drug will reach peak sales of $6.6 billion in the U.S. alone, with additional launches planned in Europe, the U.K., and Japan throughout 2026. The company’s sales force engaged with essentially all 27,000 pulmonologists in the U.S. even before launch, setting up what analysts are calling “one of the most anticipated drug launches of the year.”
Key Technical and Fundamental Drivers
Landmark FDA Approval → First-in-Disease Therapy BRINSUPRI received FDA approval on August 12, 2025, as the first-ever treatment for non-cystic fibrosis bronchiectasis and the first dipeptidyl peptidase 1 (DPP1) inhibitor approved for any indication, creating an entirely new treatment category.
Blockbuster Sales Potential → $6.6 Billion Peak Mizuho analysts project BRINSUPRI will reach peak sales of $6.6 billion in the U.S. market alone, with the company’s own internal estimates at $5 billion, positioning this as a potential mega-blockbuster drug that could propel Insmed into the ranks of major biotechs like Vertex Pharmaceuticals.
European Approval Imminent → October CHMP Positive Opinion In October 2025, the Committee for Medicinal Products for Human Use of the European Medicines Agency adopted a positive opinion recommending approval of BRINSUPRI in the European Union, with regulatory submissions in the U.K. and Japan also accepted and commercial launches anticipated in 2026.
Strong Clinical Data → 21% Exacerbation Reduction The landmark Phase 3 ASPEN trial—the largest bronchiectasis study ever conducted with 1,721 patients across 391 sites in 35 countries—showed BRINSUPRI reduced annualized pulmonary exacerbations by 21% compared to placebo, with nearly half of patients remaining exacerbation-free after 52 weeks.
Expanding Pipeline → Multiple Catalysts Ahead Beyond bronchiectasis, Insmed completed enrollment in October 2025 for the Phase 2b CEDAR study of brensocatib in hidradenitis suppurativa with topline data expected in the first half of 2026, while Phase 3 studies of its treprostinil palmitil inhalation powder (TPIP) for multiple pulmonary hypertension indications are launching throughout 2025-2026.
Market Takeaway Insmed represents a classic biotech transformation story playing out in real-time—a company transitioning from single-product status to potential blockbuster-driven growth. BRINSUPRI’s approval in August 2025 fundamentally changed Insmed’s investment thesis, as the company now has two commercial products (alongside its existing ARIKAYCE franchise) and is addressing a massive unmet medical need with no competition. The 500,000 diagnosed U.S. patients represent just the tip of the iceberg, as bronchiectasis is widely considered underdiagnosed.
The commercial execution appears strong, with Leerink Partners analysts noting that the company has “left no stone unturned to have the strongest launch possible,” having engaged with essentially every pulmonologist in the country before launch. While it will take about a month post-approval for meaningful sales to begin appearing in quarterly results, the setup for a sustained commercial ramp looks compelling. The European approval process is progressing rapidly with the October 2025 CHMP positive opinion, opening up an additional 600,000 patients across the EU5 countries and 150,000 in Japan.
Beyond BRINSUPRI, Insmed’s pipeline offers multiple shots on goal with brensocatib being evaluated in hidradenitis suppurativa and TPIP entering Phase 3 studies across multiple pulmonary hypertension indications in 2026. For investors seeking exposure to a rare disease biotech story with a recently launched first-in-class drug, proven clinical data, and multi-billion-dollar sales potential, Insmed offers a compelling risk-reward profile as the commercial launch accelerates into 2026.