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 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.
Insmed has announced the granting of inducement awards to nine new employees as part of their recruitment strategy, compliant with NASDAQ Listing Rule 5635(c)(4). Each employee received options to purchase a total of 42,320 shares at an exercise price of $33.25, the closing price on October 1, 2020. The options come with a ten-year term and a four-year vesting schedule, designed to retain talent in a competitive industry. Insmed focuses on advancing therapies for serious and rare diseases, including ARIKAYCE, brensocatib, and treprostinil palmitil.
Insmed Incorporated (Nasdaq: INSM) announced progress at its virtual R&D Day, highlighting its expanding portfolio aimed at treating serious and rare diseases. The company initiated a Phase 1 trial for Treprostinil Palmitil Inhalation Powder (TPIP) and plans to begin a Phase 2a study for pulmonary arterial hypertension in early 2021. Insmed aims to leverage its drug brensocatib to address neutrophil-mediated diseases, starting with a Phase 3 trial for non-cystic fibrosis bronchiectasis. The company also detailed global expansion efforts for its product ARIKAYCE, expecting EU marketing authorization by October 2020.
Insmed, a biopharmaceutical company, will host a virtual R&D Day on September 30, 2020, from 10:00 a.m. to 12:30 p.m. ET. The event will highlight updates on pipeline candidates, including treprostinil palmitil and brensocatib, as well as advancements for ARIKAYCE (amikacin liposome inhalation suspension). Dr. Ronald J. Oudiz will present during the event. The conference call will be accessible live and recorded for later viewing. Insmed focuses on serious and rare diseases with its innovative therapies.
Insmed Incorporated (Nasdaq:INSM) announced participation in three virtual investor conferences in September 2020. Management will present at the H.C. Wainwright Annual Global Investment Conference on September 14, 2020, Morgan Stanley Annual Global Healthcare Conference on September 15, 2020, and the Cantor Virtual Healthcare Conference on September 17, 2020. Each presentation will be streamed live, accessible on the company's investor relations webpage and archived for 30 days. Insmed focuses on treatments for serious rare diseases, including its product ARIKAYCE®.
Insmed announced the publication of final results from the Phase 2 WILLOW study for brensocatib, a treatment for non-cystic fibrosis bronchiectasis (NCFBE), in the New England Journal of Medicine. Findings showed significant improvement in time to first pulmonary exacerbation compared to placebo, with risk reductions of 42% and 38% for two dosages. The treatment was well tolerated, with manageable adverse events. Insmed aims to initiate a Phase 3 program for brensocatib by year-end 2020, highlighting the urgency for therapeutic options in NCFBE.
Insmed Incorporated (Nasdaq: INSM) announced the grant of inducement awards to 12 new employees as per NASDAQ Listing Rule 5635(c)(4). Approved by the Compensation Committee, these awards include options to purchase a total of 84,520 shares at an exercise price of $28.17 per share, which is the closing price on September 1, 2020. The options come with a ten-year term and a four-year vesting schedule, aimed at incentivizing employee retention and commitment to the company.
Insmed Incorporated (Nasdaq: INSM) has granted inducement awards to 11 new employees, in compliance with NASDAQ Listing Rule 5635(c)(4). These awards, approved by the Compensation Committee, consist of options to purchase a total of 76,960 shares of Insmed common stock at an exercise price of $27.15 per share, based on the closing price on August 3, 2020. The options are valid for a ten-year term and will vest over four years, promoting employee retention and commitment to the company.
Insmed reported strong Q2 2020 results, achieving $42.5 million in total revenue, up from $30.0 million in Q2 2019. U.S. sales of ARIKAYCE reached $41.0 million, reflecting growth amidst COVID-19 challenges. The company also reported a net loss of $61.9 million or $0.64 per share, improving from a $66.5 million loss in the prior year. Notably, brensocatib received FDA Breakthrough Therapy Designation, and ARIKAYCE gained a positive opinion from the CHMP for treating NTM lung infections, signaling potential market expansion.
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