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 (INSM) announced that the FDA does not currently plan to hold an advisory committee meeting to discuss the New Drug Application (NDA) for brensocatib in patients with non-cystic fibrosis bronchiectasis. The FDA has maintained the application under Priority Review with a PDUFA target action date of August 12, 2025.
The NDA is supported by data from the ASPEN study, the largest Phase 3 study ever conducted in bronchiectasis patients. If approved, brensocatib would become the first approved treatment for bronchiectasis and the first in a new class of medicines called dipeptidyl peptidase 1 (DPP1) inhibitors for treating neutrophil-mediated diseases.
Insmed reported its Q4 and full-year 2024 financial results, highlighting a 19% annual growth in ARIKAYCE revenue, totaling $104.4 million for Q4 and $363.7 million for the year, exceeding guidance. The company reiterated its 2025 global ARIKAYCE revenue guidance of $405-$425 million, anticipating double-digit growth. Significant milestones include the FDA's acceptance of the NDA for brensocatib with a PDUFA target date of August 12, 2025. Key clinical trials for TPIP and ARIKAYCE are on track, with topline data expected in mid-2025 and early 2026, respectively.
Insmed ended 2024 with approximately $1.4 billion in cash and equivalents. R&D expenses rose to $179.7 million in Q4 and $598.4 million for the year, driven by increased headcount and stock-based compensation. SG&A expenses also increased significantly to $142.5 million in Q4 and $461.1 million for the year due to preparations for the anticipated U.S. launch of brensocatib. The company reported a net loss of $235.5 million for Q4 and $913.8 million for the full year.
Looking ahead, Insmed plans to invest in the commercialization of ARIKAYCE, the launch of brensocatib, and the advancement of its clinical and pre-clinical programs.
Insmed (Nasdaq: INSM), a global biopharmaceutical company, has announced its management's upcoming presentations at two major investor conferences in March 2025. The company will present at the 45th Annual TD Cowen Healthcare Conference in Boston on March 3, 2025, at 9:10 a.m. ET, and at the Leerink Partners Global Healthcare Conference in Miami on March 11, 2025, at 8:00 a.m. ET.
Both presentations will be available through live webcasts accessible via the investor relations section of Insmed's website at www.insmed.com. The webcasts will remain archived for 30 days after the events conclude.
Insmed (Nasdaq: INSM) has announced it will release its fourth-quarter and full-year 2024 financial results on Thursday, February 20, 2025. The company will host a conference call for investors at 8:00 a.m. ET on the same day to discuss the results and provide a business update.
Participants can join the call by dialing (888) 210-2654 (U.S.) or (646) 960-0278 (international) using access code 7862189. The call will be webcast live on Insmed's website. A replay will be available until February 27, 2025, through both dial-in and webcast options, with the webcast archived for 90 days on the company's website.
Insmed (INSM) has announced the granting of inducement awards to 66 new employees as approved by its Compensation Committee, in compliance with NASDAQ Listing Rule 5635(c)(4). On February 3, 2025, the employees received options to purchase a total of 108,860 shares of Insmed common stock at an exercise price of $77.88 per share, which was the closing price on the Nasdaq Global Select Market on the grant date.
The stock options come with a 10-year term and a four-year vesting schedule. The vesting terms include 25% of shares vesting on the first anniversary of the grant date, followed by 12.5% vesting every six months through the fourth anniversary, contingent upon continued employment with Insmed.
Insmed (INSM) announced FDA acceptance of its New Drug Application (NDA) for brensocatib, granting Priority Review with a PDUFA target date of August 12, 2025. The drug aims to be the first-ever approved treatment for non-cystic fibrosis bronchiectasis and the first DPP1 inhibitor for neutrophil-mediated diseases.
The NDA is supported by the Phase 3 ASPEN study, which met its primary endpoint with both dosage strengths (10mg and 25mg) showing significant reduction in pulmonary exacerbations versus placebo over 52 weeks. The 25mg dose demonstrated significantly lower lung function decline. Common adverse events included COVID-19, nasopharyngitis, cough, and headache.
The company plans regulatory submissions in the EU, UK, and Japan in 2025, targeting commercial launches in 2026.
Insmed (INSM) reported strong preliminary results for 2024, with ARIKAYCE global net product sales reaching approximately $363.7 million, exceeding guidance and showing 19% year-over-year growth. The company projects 2025 ARIKAYCE revenues between $405-425 million.
Key developments include: submission of NDA for Brensocatib in bronchiectasis with anticipated U.S. launch in Q3 2025; completion of enrollment in TPIP Phase 2 study for PAH with topline data expected mid-2025; full enrollment of Phase 3 ENCORE trial for ARIKAYCE with topline data expected in Q1 2026; and FDA clearance for INS1201, their first gene therapy for DMD, with first patient dosing planned for H1 2025.
Regional ARIKAYCE sales growth: U.S. (+14%) at $254.8M, Japan (+33%) at $87.7M, and Europe (+39%) at $21.2M.
Insmed Incorporated (INSM) has announced the granting of inducement awards to 19 new employees. The awards, approved by Insmed's Compensation Committee under NASDAQ Listing Rule 5635(c)(4), were made as material inducement for employment.
The employees received options on January 2, 2025, to purchase a total of 65,930 shares of Insmed common stock at an exercise price of $69.95 per share, matching the closing price on the Nasdaq Global Select Market on the grant date.
The options come with a 10-year term and a four-year vesting schedule, with 25% vesting after the first year and 12.5% vesting every six months thereafter until the fourth anniversary, contingent on continued employment.
Insmed (Nasdaq: INSM) has announced its management team will deliver a presentation at the 43rd Annual J.P. Morgan Healthcare Conference in San Francisco. The presentation is scheduled for Monday, January 13, 2025, at 3:00 p.m. PT/6:00 p.m. ET.
The event will be accessible via webcast through the investor relations section of Insmed's website at www.insmed.com. The webcast recording will remain available for 30 days after the live presentation concludes.
Insmed (INSM) has granted inducement awards to 30 new employees as part of their employment agreements. The awards consist of options to purchase a total of 64,240 shares of Insmed common stock at an exercise price of $72.42 per share, which was the closing price on the Nasdaq Global Select Market on the grant date of December 2, 2024.
The stock options have a 10-year term and follow a four-year vesting schedule: 25% vests after the first year, followed by 12.5% vesting every six months until the fourth anniversary, contingent on continued employment with Insmed.
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