Insmed Inc Stock Price, News & Analysis

Insmed (INSM) will present 11 abstracts at the American Thoracic Society (ATS) 2025 International Conference in San Francisco from May 18-21, 2025. The presentations focus on their respiratory portfolio, featuring new analyses from the Phase 3 ASPEN study of brensocatib in bronchiectasis patients.

Key presentations include:

• Multiple prespecified subgroup analyses examining brensocatib's efficacy and safety
• Post-hoc analysis of lung function changes in bronchiectasis patients
• Health status improvements in patients with Mycobacterium Avium Complex (MAC) lung disease
• Clinical data from Phase 2a study of treprostinil palmitil inhalation powder in pulmonary hypertension

Chief Medical Officer Dr. Martina Flammer emphasized the significance of presenting new subgroup analyses from ASPEN, noting it as the largest Phase 3 clinical trial in bronchiectasis to date, particularly important given no treatments are specifically approved for this condition.

Insmed (INSM) has granted inducement awards to 18 new employees as approved by the company's Compensation Committee under NASDAQ Listing Rule 5635(c)(4). The awards, issued on March 7, 2025, consist of options to purchase 47,960 shares of Insmed common stock at an exercise price of $74.89 per share, matching the closing price on the Nasdaq Global Select Market on the grant date.

The stock options come with a 10-year term and feature a four-year vesting schedule. The vesting terms include 25% of shares vesting on the first anniversary, followed by 12.5% vesting every six months through the fourth anniversary, contingent on continued employment.

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.