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 that the first patient was dosed in December 2020 for the frontline clinical trial program of ARIKAYCE® in treating nontuberculous mycobacterial (NTM) lung disease caused by Mycobacterium avium complex (MAC). This program includes ARISE, a study validating patient-reported outcome tools, and ENCORE, a pivotal trial assessing ARIKAYCE's efficacy and safety. ARIKAYCE, the first FDA-approved therapy for MAC lung disease, aims to secure full approval and support supplemental drug applications. The trials seek to establish ARIKAYCE as a new standard of care.
Insmed Incorporated (Nasdaq: INSM) announced on December 4, 2020, the granting of inducement awards to seven new employees as part of NASDAQ Listing Rule 5635(c)(4). Each employee received options to purchase a total of 13,560 shares at an exercise price of $39.14, reflecting the closing price on December 1, 2020. The options have a ten-year term and a four-year vesting schedule, with 25% vesting after one year and 12.5% every six months thereafter, contingent on continued employment.
Insmed announced the dosing of the first patient in the Phase 3 ASPEN study evaluating brensocatib for bronchiectasis treatment. This Phase 3 trial is centered on exploring the efficacy and safety of brensocatib, which has shown promising results in the Phase 2 WILLOW study. Approximately 1,620 patients across 40 countries will participate, with a primary focus on pulmonary exacerbation rates over 52 weeks. Brensocatib has received Breakthrough Therapy and PRIME designations, indicating its potential importance in addressing this serious condition.
Insmed Incorporated (Nasdaq: INSM) announced its participation in the virtual Evercore ISI 3rd Annual HealthCONx Conference, scheduled for December 1, 2020, at 8:00 a.m. ET. This presentation aims to showcase the company's advancements in treating serious and rare diseases. The event will include a live webcast accessible through their investor relations page, with an archived version available for 30 days post-event. Insmed's mission focuses on transforming the lives of patients with chronic pulmonary diseases and other unmet medical needs.
Insmed announced that the European Medicines Agency (EMA) granted Priority Medicines (PRIME) designation to brensocatib for treating non-cystic fibrosis bronchiectasis (NCFBE). This designation aims to support drugs that address unmet medical needs. Brensocatib, an oral DPP1 inhibitor, is designed to reduce inflammation in NCFBE patients. Following positive Phase 2 trial results, Insmed plans to initiate the Phase 3 ASPEN trial by year-end 2020. Brensocatib also holds Breakthrough Therapy Designation from the FDA, enhancing its development prospects.
Insmed announced on November 6, 2020, that it granted inducement awards to 10 new employees as per NASDAQ Listing Rule 5635(c)(4). The awards included options to purchase a total of 50,660 shares of common stock at an exercise price of $31.45 per share, the closing price on November 2, 2020. These options have a ten-year term and a four-year vesting schedule, with partial vesting occurring annually and semi-annually.
Insmed, a global biopharmaceutical company, announced its participation in two upcoming virtual investor conferences. Management will present at the 29th Annual Credit Suisse Virtual Healthcare Conference on November 10, 2020, at 3:30 p.m. ET, and at the Stifel 2020 Virtual Healthcare Conference on November 17, 2020, at 10:00 a.m. ET. Both events will be webcast live, with recordings available for 30 days afterward. Insmed focuses on therapies for serious and rare diseases, including a first-in-disease therapy for chronic lung disease.
Insmed reported a robust third quarter for 2020, with total revenue reaching $43.6 million, a 12% increase from the previous year. U.S. net sales accounted for $42 million. The net loss was $63.7 million or $0.63 per share, slightly higher than the prior year. Key developments included ARIKAYCE's approval in the EU and expanded efficacy data from the FDA. Insmed also initiated a Phase 1 study for TPIP and planned a Phase 3 study for brensocatib. As of September 30, 2020, cash reserves stood at $588.8 million.
Insmed Incorporated (Nasdaq: INSM) announced that the European Commission has granted marketing authorization for ARIKAYCE® to treat nontuberculous mycobacterial (NTM) lung infections caused by Mycobacterium avium complex (MAC) in adults without cystic fibrosis. This approval follows the positive opinion from the EMA's Committee for Medicinal Products and is based on the Phase 3 CONVERT study, which showed ARIKAYCE improves sputum culture conversion rates. Insmed plans to launch ARIKAYCE in Germany and subsequently in other EU markets, supporting patients through tailored programs.
Insmed Incorporated (Nasdaq: INSM) announced the release of its third quarter 2020 financial results on October 29, 2020. A conference call for investors will take place at 8:30 a.m. ET to discuss these results. Interested participants can join by calling (833) 340-0284 domestically or (236) 712-2425 internationally and using conference ID number 8292364. A replay will be available two hours after the call until November 12, 2020. Insmed focuses on transforming lives through innovative therapies for rare diseases, including ARIKAYCE® for MAC lung disease.
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