ARIKAYCE®
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Insmed Announces Positive Topline Results from Phase 3b ENCORE Study of ARIKAYCE® (Amikacin Liposome Inhalation Suspension) in Patients with MAC Lung Disease
Prnewswire· 2026-03-23 11:00
Core Insights - Insmed announced positive topline results from the Phase 3b ENCORE study of ARIKAYCE, demonstrating significant improvements in respiratory symptoms and culture conversion rates in patients with MAC lung disease [1][2][3] Study Results - The primary endpoint showed a change from baseline in Respiratory Symptom Score at Month 13: ARIKAYCE group improved by 17.77 points compared to 14.66 points in the placebo group, with a treatment difference of 3.11 points (p=0.0299) [2] - Culture conversion rates at Month 6 were 87.8% for ARIKAYCE versus 57.0% for placebo (30.8% difference, p<0.0001) [2][3] - At Month 12, culture conversion rates were 84.7% for ARIKAYCE and 61.3% for placebo (23.3% difference, p<0.0001) [3] - At Month 13, culture conversion rates were 82.4% for ARIKAYCE and 55.6% for placebo (26.8% difference, p<0.0001) [3] - Durable culture conversion at Month 15 was 76.2% for ARIKAYCE compared to 47.6% for placebo (28.6% difference, p<0.0001) [3] Future Plans - Insmed plans to file a supplemental NDA for ARIKAYCE with the FDA in the second half of 2026 to support potential label changes and will also submit data to the PMDA in Japan [1][3] Safety Profile - The safety profile of ARIKAYCE was consistent with previous data, with no new safety signals observed [4] - The most common treatment-emergent adverse events (TEAEs) in the ARIKAYCE group included dysphonia (58.7%), cough (32.9%), and fatigue (17.4%) [5][6] - Serious TEAEs were reported in 14.1% of ARIKAYCE patients compared to 11.3% in the placebo group [5] Study Design - The ENCORE study was a randomized, double-blind, placebo-controlled trial involving 425 patients, with 82.4% experiencing their first MAC infection [9][10] - Patients were treated with ARIKAYCE plus multidrug therapy or placebo for 12 months, followed by a three-month assessment period for durability of culture conversion [9] Company Overview - Insmed is a biopharmaceutical company focused on developing therapies for serious diseases, with a commitment to delivering first- and best-in-class treatments [33][34]
Why Insmed Incorporated (INSM) is One of the Best Strong Buy Healthcare Stocks to Invest In
Yahoo Finance· 2026-02-27 04:53
Core Viewpoint - Insmed Incorporated (NASDAQ:INSM) is highlighted as a strong buy healthcare stock, with a recent price target adjustment by Mizuho from $211 to $204 while maintaining an Outperform rating, following positive comments on the Brinsupri launch after the fiscal Q4 report [1][2]. Financial Performance - Insmed reported total revenues of $606.4 million for the full year 2025, with BRINSUPRI revenues at $144.6 million for fiscal Q4 and $172.7 million for the full year 2025 [2]. - ARIKAYCE revenues reached $119.2 million for the quarter and $433.8 million for the full year 2025, reflecting a 19% annual growth and exceeding the upper end of the full year 2025 guidance [2]. - The company anticipates BRINSUPRI revenues to exceed $1 billion for full-year 2026 and has reiterated ARIKAYCE revenue guidance of $450 million to $470 million for the same period [3]. Company Overview - Insmed is a global biopharmaceutical company focused on developing and commercializing therapies for patients with rare diseases, with a pipeline that includes Brensocatib and Treprostinil Palmitil Inhalation Powder (TPIP) [4].
Insmed Incorporated (INSM) Gained from Its Lead Product ARIKAYCE
Yahoo Finance· 2026-02-24 12:19
Core Insights - Artisan Mid Cap Fund's fourth-quarter 2025 performance showed a decline, with Investor Class at -0.44%, Advisor Class at -0.37%, and Institutional Class at -0.35%, compared to -3.70% for the Russell Midcap® Growth Index, indicating relative resilience in a challenging market [1]. Group 1: Fund Performance - The Fund seeks investments in companies with franchise characteristics, strong earnings trajectories, and trading at a discount to estimated private market value [1]. - Continued strength in information technology and health care sectors contributed positively to the Fund's performance during the quarter [1]. Group 2: Insmed Incorporated (NASDAQ:INSM) - Insmed Incorporated specializes in therapies for serious and rare diseases, with a market capitalization of $33.917 billion [2]. - The stock closed at $159.03 per share on February 23, 2026, with a one-month return of -2.22% and a 52-week gain of 105.20% [2]. - Insmed was a top contributor to the Fund's performance in Q4, driven by strong sales of its lead product ARIKAYCE® and the successful launch of Brinsupri™, which generated $28 million in initial sales [3]. Group 3: Hedge Fund Interest - Insmed was held by 74 hedge fund portfolios at the end of Q4, an increase from 73 in the previous quarter, indicating growing interest among institutional investors [4]. - Despite its potential, the company is not among the 30 most popular stocks among hedge funds, with some analysts suggesting that certain AI stocks may offer greater upside potential [4].
Here’s What Lifted Insmed Incorporated (INSM) in Q3
Yahoo Finance· 2025-11-17 15:10
Core Insights - Artisan Partners' "Artisan Small Cap Fund" reported strong performance in Q3 2025, with major US indices reaching record highs and the fund's Investor Class returning 8.69% [1] - Insmed Incorporated (NASDAQ:INSM) emerged as a significant contributor to the fund's performance, with a one-month return of 15.07% and a remarkable 190.08% increase over the past 52 weeks [2][3] Fund Performance - The Artisan Small Cap Fund's Investor Class fund ARTSX returned 8.69%, Advisor Class fund APDSX returned 8.75%, and Institutional Class fund APHSX returned 8.73% in Q3 2025 [1] - The Russell 2000 Growth Index outperformed the fund with a return of 12.19% during the same period [1] Insmed Incorporated Highlights - Insmed is a biopharmaceutical company focused on serious pulmonary diseases, with its lead product ARIKAYCE® treating lung infections resistant to standard therapies [3] - The company received FDA approval for Brinsupri™, a once-daily oral treatment for non-cystic fibrosis bronchiectasis, addressing a significant unmet medical need with over one million diagnosed patients in the US, Europe, and Japan [3] - Insmed's market capitalization reached $41.209 billion as of November 14, 2025, with shares closing at $193.22 [2] Investment Sentiment - Insmed was held by 82 hedge fund portfolios at the end of Q2 2025, an increase from 64 in the previous quarter, indicating growing interest among institutional investors [4] - Despite Insmed's potential, some analysts suggest that certain AI stocks may offer greater upside potential with less downside risk [4]