Welcome to our dedicated page for Insmed news (Ticker: INSM), a resource for investors and traders seeking the latest updates and insights on Insmed stock.
Insmed, Inc. (Symbol: INSM) is a global biopharmaceutical company headquartered in Bridgewater, NJ, with a mission to transform the lives of patients with serious and rare diseases. The company is committed to developing and bringing to market therapies that significantly improve patient lives, focusing on the entire patient journey from diagnosis and treatment to daily living.
Insmed's flagship product, ARIKAYCE (amikacin liposome inhalation suspension), is approved in the US for treating Mycobacterium Avium Complex (MAC) lung disease in adult patients who have limited or no alternative treatment options. ARIKAYCE, utilizing Insmed's proprietary PULMOVANCE® liposomal technology, delivers amikacin directly to the lungs, reducing systemic exposure and associated toxicities. It is administered using the Lamira® Nebulizer System developed by PARI Pharma GmbH, known for its efficiency and portability.
The company’s clinical pipeline includes multiple promising candidates. Notable among them is Brensocatib, a novel oral reversible inhibitor of dipeptidyl peptidase 1 (DPP1). It is being developed for treating non-cystic fibrosis bronchiectasis and other neutrophil-mediated diseases. Another significant pipeline product is TPIP (Treprostinil Palmitil Inhalation Powder), an inhaled formulation being evaluated for pulmonary arterial hypertension and other serious pulmonary disorders.
Insmed has demonstrated robust financial performance, with significant revenue growth driven by ARIKAYCE. The company continues to invest heavily in research and development, with plans to expand its product portfolio and market reach globally.
Insmed's strategic partnerships and collaborations play a crucial role in advancing its mission. These include collaborations with PARI Pharma for the Lamira® Nebulizer System and AstraZeneca AB for utilizing their expertise in respiratory diseases.
Recent updates include positive financial results for the third quarter of 2023, robust revenue growth from ARIKAYCE, and significant progress in clinical trials. Noteworthy are the topline results from the Phase 3 ASPEN study for Brensocatib, indicating its potential as a first-in-class treatment. Insmed plans to file a New Drug Application (NDA) with the FDA for Brensocatib by late 2024, aiming for a potential launch in 2025.
The company is also advancing its early-stage research engine, exploring innovative technologies such as artificial intelligence-driven protein engineering and gene therapy, positioning itself at the forefront of biopharmaceutical innovation.
Insmed announced positive topline results from the ASPEN Phase 3 study of brensocatib in patients with non-cystic fibrosis bronchiectasis. The study met its primary endpoint, showing statistically significant reductions in pulmonary exacerbations (PEs) for both dosage strengths versus placebo. Secondary endpoints also showed significant improvements. Brensocatib was well-tolerated, and Insmed plans to file a New Drug Application with the FDA in Q4 2024, aiming for a mid-2025 U.S. launch. If approved, brensocatib would be the first treatment for bronchiectasis and the first dipeptidyl peptidase 1 (DPP1) inhibitor. Detailed results will be presented at an upcoming medical meeting.
Study findings included a 21.1% reduction in annualized rate of PEs for the 10 mg dose and 19.4% for the 25 mg dose. Secondary outcomes included an 18.7% and 17.5% prolongation in time to first PE for the respective doses. Brensocatib also showed improvements in forced expiratory volume and quality of life scores. The study engaged over 460 sites globally. Insmed will host an investor call on May 28, 2024, to discuss the results.
Insmed will host an investor call on May 28, 2024, at 8:00 am ET to discuss the topline results from the Phase 3 ASPEN study of brensocatib in patients with non-cystic fibrosis bronchiectasis. The company will release the results at 6:30 am ET, prior to the call. The ASPEN study is a global, randomized, double-blind, placebo-controlled trial evaluating the efficacy, safety, and tolerability of brensocatib. The conference call can be accessed via phone or webcast, with a replay available until June 27, 2024.
Insmed presented positive data from its Phase 3 ARISE study of ARIKAYCE® (amikacin liposome inhalation suspension) at the American Thoracic Society 2024 International Conference. The study evaluated patients with nontuberculous mycobacterial (NTM) lung disease caused by Mycobacterium avium complex (MAC). ARIKAYCE combined with a macrolide-based regimen showed significantly greater improvements in respiratory symptoms and higher rates of culture conversion compared to the macrolide regimen alone. Quality of Life-Bronchiectasis (QOL-B) scores improved through Month 7 for ARIKAYCE patients, whereas improvements plateaued or worsened for the comparator group after Month 3. No patients developed resistance to ARIKAYCE or macrolides. Adverse event rates were higher in the ARIKAYCE arm but were consistent with expected safety profiles.
Insmed Incorporated reported total revenue of $75.5 million for the first quarter of 2024, showing 16% growth over the same period in 2023. The company highlighted positive safety and tolerability data from TPIP studies and encouraging results from PAH trials. They reiterated their 2024 revenue guidance of $340-360 million for global ARIKAYCE. Insmed continues to focus on commercial expansion, R&D for brensocatib and TPIP, and early-stage research programs.
Insmed Incorporated (Nasdaq:INSM) will present at the BofA Securities Health Care Conference 2024, aiming to transform the lives of patients with serious and rare diseases. The fireside chat will take place on May 14, 2024, at 2:20 p.m. PT (5:20 p.m. ET) in Las Vegas, NV. The webcast will be accessible on the company's investor relations website for 30 days post-event.
Insmed Incorporated (INSM) granted inducement awards to 63 new employees as a material inducement to their employment. The employees received options to purchase 410,300 shares of Insmed common stock at an exercise price of $25.59 per share. The options have a 10-year term and a four-year vesting schedule.
FAQ
What is the current stock price of Insmed (INSM)?
What is the market cap of Insmed (INSM)?
What is Insmed's primary mission?
What is ARIKAYCE?
What are Brensocatib and TPIP?
Where is Insmed headquartered?
What are Insmed's recent financial highlights?
What are the strategic partnerships of Insmed?
What are the latest developments in Insmed's clinical trials?
What is Insmed's approach to early-stage research?
What is the Lamira® Nebulizer System?
When does Insmed plan to file an NDA for Brensocatib?
