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Insmed, Inc. - INSM STOCK NEWS

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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.

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Insmed Incorporated (Nasdaq: INSM), a global biopharmaceutical company, has announced that it will release its third-quarter 2024 financial results on Thursday, October 31, 2024. The company will host a conference call for investors at 8:00 a.m. ET on the same day to discuss the financial results and provide a business update.

Shareholders and interested parties can participate in the conference call by dialing (888) 210-2654 (U.S.) or (646) 960-0278 (international) and using the access code 7862189. The call will also be webcast live on Insmed's website. A replay of the call will be available until November 7, 2024, and a webcast will be archived for 90 days on the company's website.

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Insmed Incorporated (Nasdaq: INSM) presented positive late-breaking subgroup data from the Phase 3 ASPEN study of brensocatib in patients with non-cystic fibrosis bronchiectasis at the CHEST 2024 Annual Meeting. The subgroup analyses showed consistent positive impact on the rate of exacerbations across most prespecified subgroups, aligning with the overall trial results. Notably, brensocatib 25 mg demonstrated a reduced decline in lung function (FEV1) at Week 52 versus placebo for all prespecified subgroups.

The drug was well-tolerated, with common adverse events including COVID-19, nasopharyngitis, cough, and headache. Insmed plans to file a New Drug Application with the FDA in Q4 2024, aiming for a U.S. launch in mid-2025 and European and Japanese launches in H1 2026. If approved, brensocatib would be the first approved treatment for bronchiectasis and the first approved DPP1 inhibitor.

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Insmed Incorporated (Nasdaq: INSM) has announced the granting of inducement awards to 52 new employees in accordance with NASDAQ Listing Rule 5635(c)(4). The awards, approved by Insmed's Compensation Committee, were made as a material inducement to each employee's entry into employment with the Company.

On October 1, 2024, the new employees received options to purchase an aggregate of 106,160 shares of Insmed common stock at an exercise price of $72.88 per share, which was the closing trading price on the Nasdaq Global Select Market on the date of grant. The options have a 10-year term and a four-year vesting schedule, with 25% vesting on the first anniversary and 12.5% vesting every six months thereafter through the fourth anniversary, subject to continued service with Insmed.

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Insmed Incorporated (Nasdaq: INSM) has announced the granting of inducement awards to 60 new employees, approved by the company's Compensation Committee in accordance with NASDAQ Listing Rule 5635(c)(4). On September 3, 2024, the employees received options to purchase a total of 137,140 shares of Insmed common stock at an exercise price of $73.31 per share, which was the closing trading price on the Nasdaq Global Select Market on the grant date.

The options have a 10-year term and a four-year vesting schedule. 25% of the shares will vest on the first anniversary of the grant date, followed by 12.5% vesting every six months thereafter until the fourth anniversary, subject to the employee's continued service with Insmed.

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Insmed reported Q2 2024 financial results with ARIKAYCE total revenue of $90.3 million, reflecting 17% growth over Q2 2023. The company reiterated its 2024 global ARIKAYCE revenue guidance of $340-$360 million. Key highlights include:

1. U.S. launch readiness for Brensocatib in Bronchiectasis on track with NDA submission expected in Q4 2024.

2. Primary endpoint for ENCORE study of ARIKAYCE agreed upon with FDA.

3. Positive topline data from Phase 3 ASPEN study of Brensocatib reported in May 2024.

4. Q2 2024 net loss of $300.6 million, or $1.94 per share.

5. Cash and cash equivalents of $1,246.8 million as of June 30, 2024.

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Insmed (Nasdaq: INSM) announced inducement grants for 97 new employees on August 2, 2024. The grants, approved under NASDAQ Listing Rule 5635(c)(4), include options to purchase a total of 133,130 shares at $75.33 per share, the closing price on the grant date, August 1, 2024.

The options have a 10-year term and follow a four-year vesting schedule: 25% vests after the first year, and 12.5% every six months thereafter, contingent on continued employment.

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Insmed Incorporated (Nasdaq: INSM), a global biopharmaceutical company focused on rare diseases, has announced its upcoming second-quarter 2024 financial results conference call. The call is scheduled for Thursday, August 8, 2024, at 8:00 a.m. ET. Investors and interested parties can participate by dialing (888) 210-2654 (U.S.) or (646) 960-0278 (international) with access code 7862189. The call will also be webcast live on the company's website.

A replay of the conference call will be available until September 7, 2024, and a webcast recording will be archived for 90 days on Insmed's website. This event provides an opportunity for stakeholders to gain insights into Insmed's financial performance and receive updates on the company's business activities.

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Insmed, a global biopharmaceutical company, announced inducement grants to 18 new employees under NASDAQ Listing Rule 5635(c)(4). The grants, approved by Insmed's Compensation Committee, include options to purchase 38,110 shares of Insmed common stock at an exercise price of $66.34 per share. These options, granted on July 1, 2024, have a 10-year term and a four-year vesting schedule. Specifically, 25% of the shares will vest on the first anniversary of the grant date, with 12.5% vesting every six months thereafter, conditional upon the employees' continued service. This move aligns with Insmed's mission to transform the lives of patients with serious and rare diseases by attracting and retaining top talent.

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Insmed announced additional positive results from the ASPEN study on brensocatib at the 7th World Bronchiectasis Conference. The study assessed efficacy, safety, and tolerability of brensocatib in non-cystic fibrosis bronchiectasis. Key findings include a 21.1% risk reduction in pulmonary exacerbations for the 10 mg group and 19.4% for the 25 mg group, compared to placebo. The 25 mg dose also showed significantly less decline in lung function (FEV1) and forced vital capacity (FVC). Both doses improved Quality of Life scores, with nominally significant improvements in the 25 mg group. Brensocatib demonstrated a favorable safety profile, with common adverse events including COVID-19 and nasopharyngitis. Insmed plans to file a New Drug Application with the FDA in Q4 2024, with a potential U.S. launch in mid-2025, followed by Europe and Japan in 2026.

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Insmed announced the redemption of all $225 million in outstanding 1.75% Convertible Senior Notes due 2025. The redemption date is set for August 9, 2024, and the redemption price will be 100% of the principal amount plus accrued interest, totaling approximately $1,001.17 per $1,000 principal. Interest on the Notes will cease to accrue after this date. Holders may convert their Notes into shares of Insmed common stock at a rate of 25.5384 shares per $1,000 principal until August 8, 2024. This conversion could result in up to 5,746,140 shares being issued if all Notes are converted.

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FAQ

What is the current stock price of Insmed (INSM)?

The current stock price of Insmed (INSM) is $81.01 as of February 4, 2025.

What is the market cap of Insmed (INSM)?

The market cap of Insmed (INSM) is approximately 14.3B.

What is Insmed's primary mission?

Insmed's mission is to transform the lives of patients with serious and rare diseases by developing and bringing to market innovative therapies.

What is ARIKAYCE?

ARIKAYCE (amikacin liposome inhalation suspension) is Insmed's first commercial product, approved for treating Mycobacterium Avium Complex (MAC) lung disease in adult patients with limited or no alternative treatment options.

What are Brensocatib and TPIP?

Brensocatib is an oral reversible inhibitor of dipeptidyl peptidase 1 (DPP1) being developed for non-cystic fibrosis bronchiectasis and other inflammatory diseases. TPIP is an inhaled formulation of treprostinil for treating pulmonary arterial hypertension and other pulmonary disorders.

Where is Insmed headquartered?

Insmed is headquartered in Bridgewater, New Jersey, with additional offices and research locations worldwide.

What are Insmed's recent financial highlights?

Insmed reported significant revenue growth in the third quarter of 2023, particularly from ARIKAYCE sales, and continues to show strong financial performance.

What are the strategic partnerships of Insmed?

Insmed collaborates with PARI Pharma for the Lamira® Nebulizer System and AstraZeneca AB to leverage their expertise in respiratory diseases.

What are the latest developments in Insmed's clinical trials?

Recent highlights include positive topline results from the Phase 3 ASPEN study for Brensocatib, which showed significant treatment benefits, and ongoing evaluations of TPIP for various serious pulmonary conditions.

What is Insmed's approach to early-stage research?

Insmed is advancing an early-stage research engine encompassing innovative technologies, including artificial intelligence-driven protein engineering and gene therapy.

What is the Lamira® Nebulizer System?

The Lamira® Nebulizer System, developed by PARI Pharma, is a portable device used to administer ARIKAYCE efficiently through aerosolization.

When does Insmed plan to file an NDA for Brensocatib?

Insmed plans to file a New Drug Application (NDA) with the FDA for Brensocatib in the fourth quarter of 2024, with hopes for a U.S. launch in mid-2025.
Insmed, Inc.

Nasdaq:INSM

INSM Rankings

INSM Stock Data

14.31B
176.76M
0.91%
112.07%
8.43%
Biotechnology
Pharmaceutical Preparations
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United States of America
BRIDGEWATER