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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) has announced positive topline results from a Phase 1 study of treprostinil palmitil inhalation powder (TPIP) in healthy volunteers. The study demonstrated that TPIP is generally safe and well tolerated, supporting once-daily dosing. The trial involved 42 participants and assessed both single and multiple doses, with the highest single dose being 675 µg. Common mild adverse events included cough and headache. Insmed plans further clinical development of TPIP for pulmonary arterial hypertension (PAH) and other pulmonary disorders, with additional studies expected in 2021.
Insmed Incorporated (Nasdaq: INSM) has announced the release of topline data from its Phase 1 trial of treprostinil palmitil inhalation powder (TPIP) on February 19, 2021. This trial targets the treatment of pulmonary arterial hypertension (PAH) and rare pulmonary disorders. A conference call for investors will be held at 8:30 a.m. ET on the same day to discuss the findings and provide updates. TPIP is a unique formulation developed in-house, showcasing Insmed's commitment to addressing unmet medical needs.
Insmed Incorporated (Nasdaq: INSM) will release its fourth-quarter and full-year 2020 financial results on February 25, 2021. Management will host a conference call at 8:30 a.m. ET to discuss these results and provide a business update. Interested participants can join by dialing the provided numbers or via a live webcast. The replay of the call will be available two hours post completion until March 27, 2021. Insmed focuses on therapies for serious rare diseases, with its first product approved for a chronic lung disease.
On February 5, 2021, Insmed Incorporated (Nasdaq: INSM) announced the granting of inducement awards to 14 new employees, in compliance with NASDAQ Listing Rule 5635(c)(4). These awards included options for a total of 65,980 shares of common stock at an exercise price of $37.44 per share, aligning with the closing price on February 1, 2021. The options have a ten-year term and a four-year vesting schedule, promoting employee retention and aligning interests with shareholder value.
Insmed, a biopharmaceutical company focused on rare and serious diseases, will present at the 39th Annual J.P. Morgan Healthcare Conference on January 12, 2021, at 7:30 a.m. ET. This event will be available for live streaming and archived for 30 days. Insmed's mission is to improve patient lives through innovative therapies, including its first commercial product for a lung disease and a pipeline targeting unmet medical needs in inflammatory diseases and rare pulmonary disorders. More information can be found on www.insmed.com.
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.