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—Paul Hudson, Former CEO of Sanofi and Novartis Pharmaceuticals, and Utpal Koppikar, CFO of Verily Health and Veteran Biopharma Finance Leader, Join as New Independent Directors—

, /PRNewswire/ -- Insmed Incorporated (Nasdaq: INSM), a people-first global biopharmaceutical company striving to deliver first- and best-in-class therapies to transform the lives of patients facing serious diseases, today announced the appointment of Paul Hudson and Utpal Koppikar as independent members of its Board of Directors, effective immediately. The additions bring deep expertise in global biopharma leadership, commercial strategy, and financial management to Insmed's Board as the Company continues to advance its portfolio in pursuit of its mission to transform the lives of patients with serious and rare diseases.

"Paul and Utpal are exceptional additions to our Board, and I am delighted to welcome them to Insmed," said Will Lewis, Chair and Chief Executive Officer of Insmed. "Paul's experience leading some of the world's largest and most complex biopharma organizations, combined with his deep commercial and strategic acumen, will be invaluable as we continue to execute our global growth strategy. Utpal brings demonstrated financial expertise and a strong track record of value creation across the biopharma industry, which will be a tremendous asset as we work to advance our pipeline and build long-term shareholder value. Together, they further strengthen our Board's capabilities at a pivotal time for Insmed, and I look forward to the perspectives and insights they will deliver."

Mr. Hudson brings more than three decades of senior executive leadership across some of the world's most prominent biopharmaceutical companies. He most recently served as Chief Executive Officer (CEO) of Sanofi S.A. from September 2019 through February 2026, where he led a sweeping transformation of the organization. Prior to Sanofi, Mr. Hudson served as CEO of Novartis Pharmaceuticals from 2016 to 2019 and as a member of the Novartis Executive Committee. His career in healthcare has spanned the globe, with roles in the U.S., Japan, and Europe. Prior to Novartis, he held a series of senior operational and commercial leadership positions at AstraZeneca, including President of AstraZeneca United States and Executive Vice President, North America. Mr. Hudson began his career in sales and marketing roles at Schering-Plough, GlaxoSmithKline UK, and Sanofi-Synthélabo UK.

"Insmed is a company I have admired for years — one that has built a remarkable track record of scientific innovation, clinical execution, and commercial prowess," said Paul Hudson. "I am honored to join the Board at such an exciting inflection point for the Company. I look forward to leveraging my experience in global commercial strategy and organizational transformation to support Insmed's continued growth and unwavering commitment to patients."

Mr. Koppikar is a seasoned biopharma finance executive with a distinguished track record of driving financial leadership across multiple stages of company growth. He has served as Chief Financial Officer (CFO) at Verily Health Inc., a healthcare data intelligence company focused on enabling more personal, predictive, and precise health solutions, since April 2023, where he is responsible for the finance, real estate and workplace services, and corporate development functions. Previously, Mr. Koppikar served as Executive Vice President and CFO at Atara Biotherapeutics from 2018 to 2023. Prior to Atara, he held several senior financial leadership positions at Gilead Sciences and Amgen. Mr. Koppikar currently serves on the Board of Directors of C4 Therapeutics, Inc. (Nasdaq: CCCC).

"Insmed's pipeline, commercial momentum, and people-first culture make it a truly compelling organization," said Utpal Koppikar. "I am thrilled to join the Board and look forward to helping guide the Company's financial and operational strategy as it continues to scale its business in an effort to bring additional transformative therapies to patients in need."

About Insmed

Insmed Incorporated is a people-first global biopharmaceutical company striving to deliver first- and best-in-class therapies to transform the lives of patients facing serious diseases. The Company is advancing a diverse portfolio of approved and mid- to late-stage investigational medicines — including two approved therapies to treat chronic, debilitating lung diseases — as well as cutting-edge drug discovery focused on serving patient communities where the need is greatest. Insmed's commercial portfolio and clinical pipeline are organized around three therapeutic areas: Respiratory, Immunology & Inflammation, and Neuro & Other Rare. The Company's research engine is advancing a wide range of technologies and modalities, including gene therapy, AI-driven protein engineering, RNA end-joining, and synthetic rescue, in the pursuit of future pipeline candidates.

Headquartered in Bridgewater, New Jersey, Insmed has offices and research locations throughout the United States, Europe, and Japan. Visit www.insmed.com to learn more or follow us on LinkedIn, Instagram, YouTube, and X.

Forward-looking Statements

This press release contains forward-looking statements that involve substantial risks and uncertainties. "Forward-looking statements," as that term is defined in the Private Securities Litigation Reform Act of 1995, are statements that are not historical facts and involve a number of risks and uncertainties. Words herein such as "may," "will," "should," "could," "would," "expects," "plans," "anticipates," "believes," "estimates," "projects," "predicts," "intends," "potential," "continues," and similar expressions (as well as other words or expressions referencing future events, conditions or circumstances) may identify forward-looking statements.   

The forward-looking statements in this press release are based upon the Company's current expectations and beliefs, and involve known and unknown risks, uncertainties, and other factors, which may cause the Company's actual results, performance and achievements and the timing of certain events to differ materially from the results, performance, achievements, or timings discussed, projected, anticipated, or indicated in any forward-looking statements.

The Company may not actually achieve the results, plans, intentions, or expectations indicated by the Company's forward-looking statements because, by their nature, forward-looking statements involve risks and uncertainties because they relate to events and depend on circumstances that may or may not occur in the future. For additional information about the risks and uncertainties that may affect the Company's business, please see the factors discussed in Item 1A, "Risk Factors," in the Company's Annual Report on Form 10-K for the year ended December 31, 2025 and any subsequent Company filings with the Securities and Exchange Commission (SEC).  

The Company cautions readers not to place undue reliance on any such forward-looking statements, which speak only as of the date of this press release. The Company disclaims any obligation, except as specifically required by law and the rules of the SEC, to publicly update or revise any such statements to reflect any change in expectations or in events, conditions or circumstances on which any such statements may be based, or that may affect the likelihood that actual results will differ from those set forth in the forward-looking statements.  

Contact:

Investors:
Gianna De Palma
Associate Director, Investor Relations
[email protected]

Media:
Claire Mulhearn
Vice President, Corporate Communications
[email protected]

SOURCE Insmed Incorporated

—Insmed's Largest Parallel-Running Clinical Effort to Date With Four Pivotal Phase 3 Studies Advancing Across Four Progressive Pulmonary Diseases: PALM-PAH, PALM-ILD, PALM-PPF, and PALM-IPF—

—One of the Broadest Active Global Clinical Programs in the Pulmonary Space, With the Potential to Redefine Prostanoid Therapy for These Patient Populations—

, /PRNewswire/ -- Insmed Incorporated (Nasdaq: INSM), a people-first global biopharmaceutical company striving to deliver first- and best-in-class therapies to transform the lives of patients facing serious diseases, will feature the global PALM Clinical Development Program at the American College of Chest Physicians® Annual Meeting 2026 (CHEST 2026), which is investigating treprostinil palmitil inhalation powder (TPIP) in a range of serious pulmonary diseases. The PALM Clinical Development Program includes four pivotal, parallel-running Phase 3 studies evaluating TPIP as a once-daily therapy for patients with pulmonary arterial hypertension (PAH), pulmonary hypertension associated with interstitial lung disease (PH-ILD), progressive pulmonary fibrosis (PPF), and idiopathic pulmonary fibrosis (IPF). Three PALM Phase 3 studies (PALM-PAH, PALM-ILD, PALM-PPF) have now been initiated, with the fourth study (PALM-IPF) expected to begin in the first half of 2027. This program aims to enroll more than 2,000 patients across these four studies.  

"People living with debilitating pulmonary diseases often face substantial burdens as their disease progresses, compounded by complex treatment regimens and systemic side effects that can make the demands of everyday life increasingly difficult," said Raymond Benza, MD, Chair of Cardiology, Sentara Health and Section Chief of Cardiology at the Macon & Joan Brock Virginia Health Sciences, Eastern Virginia Medical School at Old Dominion University. "As clinicians, we see firsthand the need to address the progressive nature of these diseases while considering the demands of long-term therapy. The PALM Clinical Development Program has the potential to demonstrate the impact of a novel, once-daily inhaled prostanoid therapy for patients across four serious pulmonary diseases."

Building on clinically meaningful Phase 2 efficacy and safety data evaluating TPIP in PAH and PH-ILD, the PALM Clinical Development Program is driven by the urgency to address treatment challenges and advance the standard of care for patients living with these serious diseases. The program is designed to establish investigational TPIP as a highly differentiated, purposefully designed, once-daily therapy with the potential to deliver meaningful outcomes across a broad range of patients. Background on each of the studies is as follows:

PALM-PAH is a Phase 3, randomized, double-blind, placebo-controlled, multicenter, parallel-group study evaluating the efficacy and safety of once-daily TPIP in patients with PAH (World Health Organization [WHO] Group 1 pulmonary hypertension) over 24 weeks. The primary endpoint is change from baseline in 6-minute walk distance (6MWD) at Week 24. Secondary endpoints assess functional status, disease severity, patient-reported outcomes, time to first clinical worsening, and pharmacokinetics (ClinicalTrials.gov ID: NCT07481981).
PALM-ILD is a Phase 3, randomized, double-blind, placebo-controlled, multicenter, parallel-group study evaluating the efficacy and safety of once-daily TPIP in patients with PH-ILD (WHO Group 3 pulmonary hypertension) over 24 weeks. The primary endpoint is change from baseline in 6MWD at Week 24, with time to first major morbidity or mortality event over the 24-week treatment period as a secondary endpoint (ClinicalTrials.gov ID: NCT07179380).
PALM-PPF is a Phase 3, randomized, double-blind, placebo-controlled, multicenter, parallel-group study evaluating the safety and efficacy of once-daily TPIP in adult patients with PPF over 52 to 104 weeks. The study's primary endpoint is change from baseline in absolute forced vital capacity (FVC) at Week 52, with secondary endpoints assessing disease progression, functional and physiological decline, patient-reported impact, pharmacokinetics, and safety (ClinicalTrials.gov ID: NCT07805785).
PALM-IPF will be a Phase 3, randomized, double-blind, placebo-controlled, multicenter, parallel-group study evaluating the safety and efficacy of once-daily TPIP in adult patients with IPF over 52 to 104 weeks. The study's primary endpoint will be change from baseline in absolute FVC at Week 52, with secondary endpoints assessing disease progression, functional and physiological decline, and patient-reported impact, pharmacokinetics, and safety (ClinicalTrials.gov listing forthcoming).

"As TPIP continues into the next stage of clinical development, this multi-indication PALM Clinical Development Program — the most ambitious clinical effort we are undertaking to date — is designed to break through treatment barriers that have historically limited innovation of prostanoid treatment for these complex pulmonary disorders," said Martina Flammer, M.D., MBA, Chief Medical Officer of Insmed. "These four Phase 3 studies further evaluate TPIP's potential to meaningfully improve care and, if successful, emerge as the prostanoid of choice for clinicians and patients."

About TPIP

Treprostinil palmitil inhalation powder (TPIP) is an investigational dry powder formulation of treprostinil palmitil, a next-generation pro-drug formulation of inhaled treprostinil consisting of treprostinil linked by an ester bond to a 16-carbon chain. Designed entirely in Insmed's laboratories, TPIP is a potentially highly differentiated prostanoid being developed as a once-daily therapy for the treatment of patients with pulmonary arterial hypertension (PAH), pulmonary hypertension associated with interstitial lung disease (PH-ILD), progressive pulmonary fibrosis (PPF), and idiopathic pulmonary fibrosis (IPF). TPIP is administered in a capsule-based inhalation device. TPIP is an investigational drug product that has not been approved for any indication in any jurisdiction.

About Pulmonary Arterial Hypertension

Pulmonary arterial hypertension (PAH), classified as WHO Group 1 Pulmonary Hypertension, is a serious, progressive, rare disease in which the blood vessels in the lungs narrow or become obstructed, leading to high blood pressure in the pulmonary arteries. The most common symptoms include shortness of breath, chest pain, dizziness or fainting, fatigue, and weakness. Untreated PAH can be debilitating and often fatal.

About Pulmonary Hypertension Associated With Interstitial Lung Disease

Pulmonary hypertension associated with interstitial lung disease (PH-ILD), also known as WHO Group 3 Pulmonary Hypertension, is a common and serious complication of several interstitial lung diseases (ILDs), a group of more than 200 chronic lung disorders marked by inflammation and fibrosis of the lung tissue. PH-ILD is strongly associated with impaired quality of life, decreased functional capacity, greater supplemental oxygen requirements, increased risk of hospitalizations, and higher mortality.

About Progressive Pulmonary Fibrosis

Progressive pulmonary fibrosis (PPF) is a clinical phenotype that can occur across multiple interstitial lung diseases (ILDs) and is characterized by worsening lung fibrosis over time despite treatment of the underlying disease. As fibrosis progresses, patients may experience decline in lung function accompanied by worsening breathlessness during exercise and daily activities. Over time, disease progression can lead to significant disability, respiratory failure, and premature death. 

About Idiopathic Pulmonary Fibrosis 

Idiopathic pulmonary fibrosis (IPF) is a chronic, progressive lung disease characterized by irreversible scarring of the lungs and a continual decline in lung function. Patients commonly experience worsening shortness of breath and persistent cough, which can significantly impact daily activities and quality of life.  

About Insmed

Insmed Incorporated is a people-first global biopharmaceutical company striving to deliver first- and best-in-class therapies to transform the lives of patients facing serious diseases. The Company is advancing a diverse portfolio of approved and mid- to late-stage investigational medicines — including two approved therapies to treat chronic, debilitating lung diseases — as well as cutting-edge drug discovery focused on serving patient communities where the need is greatest. Insmed's commercial portfolio and clinical pipeline are organized around three therapeutic areas: Respiratory, Immunology & Inflammation, and Neuro & Other Rare. The Company's research engine is advancing a wide range of technologies and modalities, including gene therapy, AI-driven protein engineering, RNA end-joining, and synthetic rescue, in the pursuit of future pipeline candidates.

Headquartered in Bridgewater, New Jersey, Insmed has offices and research locations throughout the United States, Europe, and Japan. Visit www.insmed.com to learn more or follow us on LinkedIn, Instagram, YouTube, and X.

Forward-looking Statements 

This press release contains forward-looking statements that involve substantial risks and uncertainties. "Forward-looking statements," as that term is defined in the Private Securities Litigation Reform Act of 1995, are statements that are not historical facts and involve a number of risks and uncertainties. Words herein such as "may," "will," "should," "could," "would," "expects," "plans," "anticipates," "believes," "estimates," "projects," "predicts," "intends," "potential," "continues," and similar expressions (as well as other words or expressions referencing future events, conditions or circumstances) may identify forward-looking statements.  

The forward-looking statements in this press release are based upon the Company's current expectations and beliefs, and involve known and unknown risks, uncertainties and other factors, which may cause the Company's actual results, performance and achievements and the timing of certain events to differ materially from the results, performance, achievements or timings discussed, projected, anticipated or indicated in any forward-looking statements. Such risks, uncertainties and other factors include, among others, the following: failure to successfully conduct the Company's current and future clinical trials for TPIP, including due to the Company's potential inability to enroll or retain sufficient patients to conduct and complete the trials or generate data necessary for regulatory approval, among other things; development of unexpected safety or efficacy concerns related to TPIP; failure of third parties on which the Company is dependent to manufacture sufficient quantities of TPIP for clinical needs, to conduct the Company's clinical trials, or to comply with the Company's agreements or laws and regulations that impact the Company's business or agreements with the Company; failure to obtain regulatory approval for TPIP in any or all of the indications for which approval is being sought; inaccuracies in the Company's estimates of the size of the potential markets for TPIP or in data the Company has used to identify physicians; expected rates of patient uptake, duration of expected treatment, or expected patient adherence or discontinuation rates, if TPIP is approved; inability of the Company or the Company's third-party manufacturers to comply with regulatory requirements related to TPIP; the Company's inability to obtain adequate reimbursement from government or third-party payors for TPIP or acceptable prices for TPIP, if approved; restrictions or other obligations imposed on the Company by agreements related to TPIP and failure to comply with the Company's obligations under such agreements; risks that the Company's clinical studies will be delayed or that serious side effects will be identified during drug development; the strength and enforceability of the Company's intellectual property rights or the rights of third parties; and the cost and potential reputational damage resulting from litigation to which the Company may become a party, including product liability claims.

The Company may not actually achieve the results, plans, intentions or expectations indicated by the Company's forward-looking statements because, by their nature, forward-looking statements involve risks and uncertainties because they relate to events and depend on circumstances that may or may not occur in the future. For additional information about the risks and uncertainties that may affect the Company's business, please see the factors discussed in Item 1A, "Risk Factors," in the Company's Annual Report on Form 10-K for the year ended December 31, 2025 and any subsequent Company filings with the Securities and Exchange Commission (SEC).  

The Company cautions readers not to place undue reliance on any such forward-looking statements, which speak only as of the date of this press release. The Company disclaims any obligation, except as specifically required by law and the rules of the SEC, to publicly update or revise any such statements to reflect any change in expectations or in events, conditions or circumstances on which any such statements may be based, or that may affect the likelihood that actual results will differ from those set forth in the forward-looking statements.  

Contact:

Investors:
Gianna De Palma
Associate Director, Investor Relations
[email protected]

Media:
Claire Mulhearn
Vice President, Corporate Communications
[email protected]

SOURCE Insmed Incorporated

—Three Late-Breaking Abstracts at CHEST 2026 Deepen Understanding of the Potential of Treprostinil Palmitil Inhalation Powder (TPIP) Across Pulmonary Arterial Hypertension (PAH) and Pulmonary Hypertension Associated With Interstitial Lung Disease (PH-ILD)—

—New Analysis From the Phase 3 ASPEN Study at CHEST 2026 Provides Additional Insights on Bronchiectasis Management—

—Phase 3b ENCORE Study Findings at IDWeek 2026 Examine Amikacin and Macrolide Resistance Development in Patients With Newly Diagnosed Mycobacterium avium Complex (MAC) Lung Disease—

, /PRNewswire/ -- Insmed Incorporated (Nasdaq: INSM), a people-first global biopharmaceutical company striving to deliver first- and best-in-class therapies to transform the lives of patients facing serious diseases, today announced new data from its respiratory portfolio will be presented at the American College of Chest Physicians® Annual Meeting 2026 (CHEST 2026), taking place Oct. 18–21 in Phoenix, and IDWeek 2026, taking place Oct. 21–24 in Washington, D.C.

"This fall medical congress season is a powerful reminder of what's possible when we stay focused on delivering meaningful solutions for patients who need them most," said Martina Flammer, M.D., MBA, Chief Medical Officer of Insmed. "From CHEST 2026 to IDWeek 2026, we're proud to share data across our respiratory portfolio, including BRINSUPRI, TPIP, and ARIKAYCE. Altogether, these presentations reflect the strength and diversity of our growing respiratory portfolio and our unwavering dedication to advancing critical therapies that have the potential to benefit the patients we aim to serve."

Insmed's Presence at CHEST 2026

Presentation highlights at CHEST 2026 include four abstracts from the treprostinil palmitil inhalation powder (TPIP) clinical development program, including three late-breaking abstracts that offer new insights into the long-term potential of TPIP in pulmonary arterial hypertension (PAH) and pulmonary hypertension associated with interstitial lung disease (PH-ILD). Additionally, a post hoc analysis of the Phase 3 ASPEN study of BRINSUPRI® (brensocatib) — the first and only approved treatment for non-cystic fibrosis bronchiectasis (NCFB) — examines patient-reported sputum color and its association with neutrophil serine proteases and exacerbations.

The Insmed presentations at CHEST 2026 are as follows:

Top Late-Breaking Abstracts: New Drugs, New Targets, New Tools, Session ID 4145, Tuesday, Oct. 20, 2026, 11:15 a.m. MT to 12:15 p.m. MT (2:15 p.m. ET to 3:15 p.m. ET)

Functional Respiratory Imaging and Clinical Outcome Correlations With Treprostinil Palmitil Inhalation Powder (TPIP) Treatment for Pulmonary Arterial Hypertension (PAH) Late-Breaking Scientific Abstract Posters (B): Pulmonary Vascular Disease, Sleep Disorders, Poster 3219, Tuesday, Oct. 20, 2026, 1:45 p.m. MT to 2:30 p.m. MT (4:45 p.m. ET to 5:30 p.m. ET)

An Open-Label Extension (OLE) Study of Treprostinil Palmitil Inhalation Powder (TPIP) in Patients With Pulmonary Arterial Hypertension (PAH): 1-Year Data From a 2-Year Study Late-Breaking Scientific Abstract Posters (B): Pulmonary Vascular Disease, Sleep Disorders, Poster 3224, Tuesday, Oct. 20, 2026, 1:45 p.m. MT to 2:30 p.m. MT (4:45 p.m. ET to 5:30 p.m. ET)

An Open-Label Extension Study of Treprostinil Palmitil Inhalation Powder (TPIP) in Patients With Pulmonary Hypertension Associated With Interstitial Lung Disease (PH-ILD)  Pulmonary Vascular Disease Scientific Abstract Posters (C): PAH, Poster 3503, Tuesday, Oct. 20, 2026, 1:45 p.m. MT to 2:30 p.m. MT (4:45 p.m. ET to 5:30 p.m. ET)

Clinical and Humanistic Burden of Pulmonary Hypertension Associated With Interstitial Lung Disease: Secondary Analysis of the Adelphi Disease Specific Programme Rapid Fire Original Investigation, CF and Non-CF Bronchiectasis Management, Session ID 4146, Monday, Oct. 19, 2026, 10:20 a.m. MT to 10:50 a.m. MT (1:20 p.m. ET to 1:50 p.m. ET)

Patient-Reported Sputum Color and Its Association With Neutrophil Serine Proteases and Exacerbations in Patients With Bronchiectasis: A Post Hoc Analysis From the ASPEN Trial Insmed's Presence at IDWeek 2026

Insmed will present two abstracts at IDWeek 2026 on ARIKAYCE® (amikacin liposome inhalation suspension), including data from the Phase 3b ENCORE study examining amikacin and macrolide resistance development in patients with newly diagnosed Mycobacterium avium complex (MAC) lung disease. A second presentation will examine real-world evidence on treatment drivers and outcomes in patients diagnosed with MAC lung disease.

Insmed presentations at IDWeek 2026 are as follows:

Antimicrobials, LB-2201.1, Thursday, Oct. 22, 2026, 10:30 a.m. ET to 10:42 a.m. ET

Amikacin and Macrolide Resistance in Patients with Newly Diagnosed Mycobacterium avium Complex Lung Disease: Results From ENCORE Respiratory Infections: Viral and Bacterial, P-475, Saturday, Oct. 24, 2026, 12:15 p.m. ET to 1:30 p.m. ET

Real-World Evidence of Treatment Drivers and Outcomes in Patients Diagnosed with Mycobacterium avium Complex Lung Disease (MACLD)  About ARIKAYCE 

ARIKAYCE® is approved in the United States as ARIKAYCE (amikacin liposome inhalation suspension), in Europe as ARIKAYCE Liposomal 590 mg Nebuliser Dispersion, and in Japan as ARIKAYCE inhalation 590 mg (amikacin sulfate inhalation drug product). Current international treatment guidelines recommend the use of ARIKAYCE for appropriate patients. ARIKAYCE is a novel, inhaled, once-daily formulation of amikacin, an established antibiotic that was historically administered intravenously and associated with severe toxicity to hearing, balance, and kidney function. Insmed's proprietary PULMOVANCE™ liposomal technology enables the delivery of amikacin directly to the lungs, where liposomal amikacin is taken up by lung macrophages where the infection resides, while limiting systemic exposure. ARIKAYCE is administered once daily using the Lamira® Nebulizer System manufactured by PARI Pharma GmbH (PARI).

About PARI Pharma and the Lamira® Nebulizer System 

ARIKAYCE is delivered by a novel inhalation device, the Lamira® Nebulizer System, developed by PARI. Lamira® is a quiet, portable nebulizer that enables efficient aerosolization of ARIKAYCE via a vibrating, perforated membrane. Based on PARI's 100-year history working with aerosols, PARI is dedicated to advancing inhalation therapies by developing innovative delivery platforms to improve patient care.

About BRINSUPRI 

BRINSUPRI® (brensocatib) is a small molecule, once-daily, oral, reversible inhibitor of dipeptidyl peptidase 1 (DPP1), designed to inhibit the activation of enzymes (neutrophil serine proteases) in neutrophils that are key drivers of chronic airway inflammation in non-cystic fibrosis bronchiectasis (NCFB). The therapy is approved in the United States as BRINSUPRI (brensocatib 10 mg and 25 mg tablets) and indicated for the treatment of NCFB in adult and pediatric patients 12 years of age or older. In the European Union and United Kingdom, BRINSUPRI (brensocatib 25 mg tablets) is approved for the treatment of NCFB in patients 12 years of age and older with two or more exacerbations in the prior 12 months. In Japan, BRINSUPRI Tablets 25 mg (brensocatib hydrate) is approved for the treatment of NCFB in adults and pediatric patients 12 years and older.

About TPIP

Treprostinil palmitil inhalation powder (TPIP) is an investigational dry powder formulation of treprostinil palmitil, a treprostinil prodrug consisting of treprostinil linked by an ester bond to a 16-carbon chain. Designed entirely in Insmed's laboratories, TPIP is a potentially highly differentiated prostanoid being developed as once-daily therapy for the treatment of patients with pulmonary arterial hypertension (PAH), pulmonary hypertension associated with interstitial lung disease (PH-ILD), progressive pulmonary fibrosis (PPF), and idiopathic pulmonary fibrosis (IPF). TPIP is administered in a capsule-based inhalation device. TPIP is an investigational drug product that has not been approved for any indication in any jurisdiction.

BOXED WARNING AND IMPORTANT SAFETY INFORMATION FOR ARIKAYCE IN THE U.S.

WARNING: RISK OF INCREASED RESPIRATORY ADVERSE REACTIONSARIKAYCE has been associated with an increased risk of respiratory adverse reactions, including hypersensitivity pneumonitis, hemoptysis, bronchospasm, and exacerbation of underlying pulmonary disease that have led to hospitalizations in some cases.

Hypersensitivity Pneumonitis has been reported with the use of ARIKAYCE in the clinical trials. Hypersensitivity pneumonitis (reported as allergic alveolitis, pneumonitis, interstitial lung disease, allergic reaction to ARIKAYCE) was reported at a higher frequency in patients treated with ARIKAYCE plus background regimen (3.1%) compared to patients treated with a background regimen alone (0%). Most patients with hypersensitivity pneumonitis discontinued treatment with ARIKAYCE and received treatment with corticosteroids. If hypersensitivity pneumonitis occurs, discontinue ARIKAYCE and manage patients as medically appropriate.

Hemoptysis has been reported with the use of ARIKAYCE in the clinical trials. Hemoptysis was reported at a higher frequency in patients treated with ARIKAYCE plus background regimen (17.9%) compared to patients treated with a background regimen alone (12.5%). If hemoptysis occurs, manage patients as medically appropriate.

Bronchospasm has been reported with the use of ARIKAYCE in the clinical trials. Bronchospasm (reported as asthma, bronchial hyperreactivity, bronchospasm, dyspnea, dyspnea exertional, prolonged expiration, throat tightness, wheezing) was reported at a higher frequency in patients treated with ARIKAYCE plus background regimen (28.7%) compared to patients treated with a background regimen alone (10.7%). If bronchospasm occurs during the use of ARIKAYCE, treat patients as medically appropriate.

Exacerbations of underlying pulmonary disease has been reported with the use of ARIKAYCE in the clinical trials. Exacerbations of underlying pulmonary disease (reported as chronic obstructive pulmonary disease (COPD), infective exacerbation of COPD, infective exacerbation of bronchiectasis) have been reported at a higher frequency in patients treated with ARIKAYCE plus background regimen (14.8%) compared to patients treated with background regimen alone (9.8%). If exacerbations of underlying pulmonary disease occur during the use of ARIKAYCE, treat patients as medically appropriate.

Anaphylaxis and Hypersensitivity Reactions: Serious and potentially life-threatening hypersensitivity reactions, including anaphylaxis, have been reported in patients taking ARIKAYCE. Signs and symptoms include acute onset of skin and mucosal tissue hypersensitivity reactions (hives, itching, flushing, swollen lips/tongue/uvula), respiratory difficulty (shortness of breath, wheezing, stridor, cough), gastrointestinal symptoms (nausea, vomiting, diarrhea, crampy abdominal pain), and cardiovascular signs and symptoms of anaphylaxis (tachycardia, low blood pressure, syncope, incontinence, dizziness). Before therapy with ARIKAYCE is instituted, evaluate for previous hypersensitivity reactions to aminoglycosides. If anaphylaxis or a hypersensitivity reaction occurs, discontinue ARIKAYCE and institute appropriate supportive measures.

Ototoxicity has been reported with the use of ARIKAYCE in the clinical trials. Ototoxicity (including deafness, dizziness, presyncope, tinnitus, and vertigo) were reported with a higher frequency in patients treated with ARIKAYCE plus background regimen (17%) compared to patients treated with background regimen alone (9.8%). This was primarily driven by tinnitus (7.6% in ARIKAYCE plus background regimen vs 0.9% in the background regimen alone arm) and dizziness (6.3% in ARIKAYCE plus background regimen vs 2.7% in the background regimen alone arm). Closely monitor patients with known or suspected auditory or vestibular dysfunction during treatment with ARIKAYCE. If ototoxicity occurs, manage patients as medically appropriate, including potentially discontinuing ARIKAYCE.

Nephrotoxicity was observed during the clinical trials of ARIKAYCE in patients with MAC lung disease but not at a higher frequency than background regimen alone. Nephrotoxicity has been associated with the aminoglycosides. Close monitoring of patients with known or suspected renal dysfunction may be needed when prescribing ARIKAYCE.

Neuromuscular Blockade: Patients with neuromuscular disorders were not enrolled in ARIKAYCE clinical trials. Patients with known or suspected neuromuscular disorders, such as myasthenia gravis, should be closely monitored since aminoglycosides may aggravate muscle weakness by blocking the release of acetylcholine at neuromuscular junctions.

Embryo-Fetal Toxicity: Aminoglycosides can cause fetal harm when administered to a pregnant woman. Aminoglycosides, including ARIKAYCE, may be associated with total, irreversible, bilateral congenital deafness in pediatric patients exposed in utero. Patients who use ARIKAYCE during pregnancy, or become pregnant while taking ARIKAYCE should be apprised of the potential hazard to the fetus.

Contraindications: ARIKAYCE is contraindicated in patients with known hypersensitivity to any aminoglycoside.

Most Common Adverse Reactions: The most common adverse reactions in Trial 1 at an incidence ≥5% for patients using ARIKAYCE plus background regimen compared to patients treated with background regimen alone were dysphonia (47% vs 1%), cough (39% vs 17%), bronchospasm (29% vs 11%), hemoptysis (18% vs 13%), ototoxicity (17% vs 10%), upper airway irritation (17% vs 2%), musculoskeletal pain (17% vs 8%), fatigue and asthenia (16% vs 10%), exacerbation of underlying pulmonary disease (15% vs 10%), diarrhea (13% vs 5%), nausea (12% vs 4%), pneumonia (10% vs 8%), headache (10% vs 5%), pyrexia (7% vs 5%), vomiting (7% vs 4%), rash (6% vs 2%), decreased weight (6% vs 1%), change in sputum (5% vs 1%), and chest discomfort (5% vs 3%).

Drug Interactions: Avoid concomitant use of ARIKAYCE with medications associated with neurotoxicity, nephrotoxicity, and ototoxicity. Some diuretics can enhance aminoglycoside toxicity by altering aminoglycoside concentrations in serum and tissue. Avoid concomitant use of ARIKAYCE with ethacrynic acid, furosemide, urea, or intravenous mannitol.

Overdosage: Adverse reactions specifically associated with overdose of ARIKAYCE have not been identified. Acute toxicity should be treated with immediate withdrawal of ARIKAYCE, and baseline tests of renal function should be undertaken. Hemodialysis may be helpful in removing amikacin from the body. In all cases of suspected overdosage, physicians should contact the Regional Poison Control Center for information about effective treatment.

U.S. INDICATION 

LIMITED POPULATION: ARIKAYCE® is indicated in adults, who have limited or no alternative treatment options, for the treatment of Mycobacterium avium complex (MAC) lung disease as part of a combination antibacterial drug regimen in patients who do not achieve negative sputum cultures after a minimum of 6 consecutive months of a multidrug background regimen therapy. As only limited clinical safety and effectiveness data for ARIKAYCE are currently available, reserve ARIKAYCE for use in adults who have limited or no alternative treatment options. This drug is indicated for use in a limited and specific population of patients.

This indication is approved under accelerated approval based on achieving sputum culture conversion (defined as 3 consecutive negative monthly sputum cultures) by Month 6. Clinical benefit has not yet been established. Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trials.

Limitation of Use:

ARIKAYCE has only been studied in patients with refractory MAC lung disease defined as patients who did not achieve negative sputum cultures after a minimum of 6 consecutive months of a multidrug background regimen therapy. The use of ARIKAYCE is not recommended for patients with non-refractory MAC lung disease.

Patients are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch, or call 1‑800‑FDA‑1088. You can also call the Company at 1-844-4-INSMED.

Please see Full Prescribing Information. 

INDICATION AND IMPORTANT SAFETY INFORMATION FOR BRINSUPRI IN THE U.S.

U.S. Indication 

BRINSUPRI is indicated for the treatment of non-cystic fibrosis bronchiectasis (NCFB) in adult and pediatric patients 12 years of age and older.

Important Safety Information

WARNINGS AND PRECAUTIONS

Dermatologic Adverse Reactions
Treatment with BRINSUPRI is associated with an increase in dermatologic adverse reactions, including rash, dry skin, and hyperkeratosis. Monitor patients for development of new rashes or skin conditions and refer patients to a dermatologist for evaluation of new dermatologic findings.

Gingival and Periodontal Adverse Reactions
Treatment with BRINSUPRI is associated with an increase in gingival and periodontal adverse reactions. Refer patients to dental care services for regular dental checkups while taking BRINSUPRI. Advise patients to perform routine dental hygiene.

Live Attenuated Vaccines
It is unknown whether administration of live attenuated vaccines during BRINSUPRI treatment will affect the safety or effectiveness of these vaccines. The use of live attenuated vaccines should be avoided in patients receiving BRINSUPRI.

ADVERSE REACTIONS
The most common adverse reactions ≥2% in the ASPEN trial included upper respiratory tract infection, headache, rash, dry skin, hyperkeratosis, and hypertension. The safety profile for adult patients with NCFB in WILLOW was generally similar to ASPEN, except for a higher incidence of gingival and periodontal adverse reactions.

Less Common Adverse Reactions
Liver Function Test Elevations
In ASPEN, there was an increase from baseline in average ALT, AST, and alkaline phosphatase levels at all time points from Week 4 through Week 56 in both BRINSUPRI 10 mg and 25 mg arms compared to placebo. The incidence of ALT >3X upper limit of normal (ULN) was 0%, 1.2%, and 0.9%; the incidence of AST >3X ULN was 0.2%, 0.3%, and 0.5%; and the incidence of alkaline phosphatase >1.5X ULN was 2.5%, 4.1%, and 4.0% in patients treated with placebo and BRINSUPRI 10 mg and 25 mg, respectively.

Skin Cancers
In ASPEN, the incidence of skin cancers among patients treated with BRINSUPRI 10 mg and 25 mg was 0.5% and 1.9%, respectively, compared to 1.1% in placebo-treated patients.

Alopecia
In ASPEN, the incidence of alopecia among patients treated with BRINSUPRI 10 mg and 25 mg was 1.5% and 1.6%, respectively, compared to 0.4% in placebo-treated patients.

USE IN SPECIFIC POPULATIONS

Pregnancy: There are no clinical data on the use of BRINSUPRI in pregnant women.

Lactation: There is no information regarding the presence of BRINSUPRI and/or its metabolite(s) in human milk, the effects on the breastfed infant, or the effects on milk production. The developmental and health benefits of breastfeeding should be considered along with the mother's clinical need for BRINSUPRI and any potential adverse effects on the breastfed child from BRINSUPRI or from the underlying maternal condition.

Pediatric use: The safety and effectiveness of BRINSUPRI for the treatment of NCFB have been established in pediatric patients aged 12 years and older. Common adverse reactions in pediatric patients aged 12 years and older enrolled in ASPEN were consistent with those in adults. The safety and effectiveness of BRINSUPRI have not been established in pediatric patients younger than 12 years of age.

Please see full US Prescribing Information.

About Insmed

Insmed Incorporated is a people-first global biopharmaceutical company striving to deliver first- and best-in-class therapies to transform the lives of patients facing serious diseases. The Company is advancing a diverse portfolio of approved and mid- to late-stage investigational medicines — including two approved therapies to treat chronic, debilitating lung diseases — as well as cutting-edge drug discovery focused on serving patient communities where the need is greatest. Insmed's commercial portfolio and clinical pipeline are organized around three therapeutic areas: Respiratory, Immunology & Inflammation, and Neuro & Other Rare. The Company's research engine is advancing a wide range of technologies and modalities, including gene therapy, AI-driven protein engineering, RNA end-joining, and synthetic rescue, in the pursuit of future pipeline candidates.

Headquartered in Bridgewater, New Jersey, Insmed has offices and research locations throughout the United States, Europe, and Japan. Visit www.insmed.com to learn more or follow us on LinkedIn, Instagram, YouTube, and X.

Forward-looking Statements 

This press release contains forward-looking statements that involve substantial risks and uncertainties. "Forward-looking statements," as that term is defined in the Private Securities Litigation Reform Act of 1995, are statements that are not historical facts and involve a number of risks and uncertainties. Words herein such as "may," "will," "should," "could," "would," "expects," "plans," "anticipates," "believes," "estimates," "projects," "predicts," "intends," "potential," "continues," and similar expressions (as well as other words or expressions referencing future events, conditions or circumstances) may identify forward-looking statements.

The forward-looking statements in this press release are based upon the Company's current expectations and beliefs, and involve known and unknown risks, uncertainties and other factors, which may cause the Company's actual results, performance and achievements and the timing of certain events to differ materially from the results, performance, achievements or timings discussed, projected, anticipated or indicated in any forward-looking statements. Such risks, uncertainties and other factors include, among others, the following: risk that interim, topline or preliminary data from our clinical trials that we announce or publish from time to time may change as more patient data become available or may be interpreted differently if additional data are disclosed; failure to successfully conduct future clinical trials for our marketed products or our product candidates and our potential inability to enroll or retain sufficient patients to conduct and complete the trials or generate data necessary for regulatory approval of our product candidates; development of unexpected safety or efficacy concerns related to our marketed products or our product candidates; risks that our clinical studies will be delayed, that serious side effects will be identified during drug development, or that any protocol amendments submitted will be rejected; failure to maintain U.S., European, or Japanese approval for ARIKAYCE or BRINSUPRI; our inability to obtain full approval of ARIKAYCE from the FDA or our failure to obtain regulatory approval to expand ARIKAYCE's indication to a broader patient population; failure to obtain, or delays in obtaining, regulatory approvals for our product candidates in the U.S., Europe, or Japan or for ARIKAYCE outside of the U.S., Europe, and Japan, including separate regulatory approval for the Lamira® Nebulizer System in each market and for each usage; and failure to successfully commercialize our product candidates, if approved by applicable regulatory authorities, or to maintain applicable regulatory approvals for our product candidates, if approved.

The Company may not actually achieve the results, plans, intentions or expectations indicated by the Company's forward-looking statements because, by their nature, forward-looking statements involve risks and uncertainties because they relate to events and depend on circumstances that may or may not occur in the future. For additional information about the risks and uncertainties that may affect the Company's business, please see the factors discussed in Item 1A, "Risk Factors," in the Company's Annual Report on Form 10-K for the year ended December 31, 2025 and any subsequent Company filings with the Securities and Exchange Commission (SEC).

The Company cautions readers not to place undue reliance on any such forward-looking statements, which speak only as of the date of this press release. The Company disclaims any obligation, except as specifically required by law and the rules of the SEC, to publicly update or revise any such statements to reflect any change in expectations or in events, conditions or circumstances on which any such statements may be based, or that may affect the likelihood that actual results will differ from those set forth in the forward-looking statements.

Contact:

Investors:
Gianna De Palma
Associate Director, Investor Relations
[email protected]

Media:
Claire Mulhearn
Vice President, Corporate Communications
[email protected]

SOURCE Insmed Incorporated

Key Takeaways Insmed shares fell nearly 7% after CFO Sara Bonstein announced she will step down on Oct. 30.Insmed reaffirmed 2026 revenue guidance, including $1.25-$1.40 billion for Brinsupri.Bonstein's exit follows her nearly seven-year tenure during Insmed's growth and $4.2 billion capital raise. Shares of Insmed (INSM - Free Report) declined nearly 7% on Monday after the company announced that its chief financial officer (CFO), Sara Bonstein, will step down from her role effective Oct. 30.

The departure came as a surprise to investors, given Bonstein’s nearly seven-year tenure as CFO and her role during a significant period of Insmed’s growth and transformation.

While Insmed did not specify the reason for this transition, it stated that Bonstein’s departure is not related to any disagreement with the company concerning accounting practices, financial statements, internal controls or operations.

Although the leadership change introduces some uncertainty for investors, Insmed reaffirmed its 2026 revenue guidance. This suggests that management has not made any changes to its current financial outlook following the CFO transition.

Why Did INSM Stock Fall on CFO Departure News?The sharp decline appears to be primarily due to investor uncertainty surrounding the unexpected departure of a long-serving senior executive. Bonstein oversaw Insmed’s finance organization during a period in which the company raised more than $4.2 billion in capital and transitioned into a commercial-stage biotech.

The timing of this departure may have further contributed to the negative reaction. Insmed is entering an important phase of growth, with Brinsupri rapidly scaling and the company targeting cash-flow positivity in 2027. Although Bonstein will remain in her role through the company’s third-quarter 2026 earnings release and conference call on Oct. 29, Insmed has already begun searching for her successor.

Year to date, shares of Insmed have lost 40% against the industry’s 3% growth.

Image Source: Zacks Investment Research

Insmed Reiterates 2026 Revenue GuidanceDespite the CFO transition, the company reaffirmed its full-year 2026 revenue guidance for its marketed products, Arikayce and Brinsupri.

Insmed continues to expect Brinsupri revenues between $1.25 billion and $1.40 billion, while Arikayce sales are in the range of $450-$470 million. Notably, the Brinsupri outlook was raised during its second-quarter results announcement from the previous guidance of at least $1 billion, while the Arikayce guidance remained unchanged.

While Arikayce is approved to treat refractory mycobacterium avium complex (MAC) lung disease in certain adults with limited or no treatment options, Brinsupri is approved for non-cystic fibrosis bronchiectasis (NCFB) in individuals aged 12 years and above.

INSM’s Zacks RankInsmed currently carries a Zacks Rank #3 (Hold).

Our Key Picks Among Biotech StocksSome better-ranked stocks in the sector include AC Immune (ACIU - Free Report) and Viking Therapeutics (VKTX - Free Report) , each carrying a Zacks Rank #2 (Buy). You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.

Over the past 60 days, estimates for AC Immune’s 2026 loss per share have narrowed from 84 cents to 60 cents. Over the same period, earnings estimate for 2027 remained unchanged at 17 cents per share. ACIU shares have lost about 14% year-to-date.

AC Immune’s earnings beat estimates in each of the trailing four quarters, with the average surprise being 33.25%.

Over the past 60 days, estimates for Viking’s 2026 loss per share have narrowed from $4.50 to $4.47, while those for 2027 have narrowed from $4.11 to $4.08. VKTX shares have lost nearly 17% year-to-date.

Viking’s earnings beat estimates in one of the trailing four quarters and missed the mark on the other three occasions, with the average negative surprise being 26.47%.

—Sara Bonstein Will Step Down as CFO on October 30 After Nearly Seven Years of Dedicated Leadership—

—Company Reaffirms Full-Year 2026 Financial Guidance—

—Company Announces Third-Quarter 2026 Financial Results Conference Call to Be Held on Thursday, October 29, 2026—

, /PRNewswire/ -- Insmed Incorporated (Nasdaq: INSM), a people-first global biopharmaceutical company striving to deliver first- and best-in-class therapies to transform the lives of patients facing serious diseases, today announced that Sara Bonstein will step down as Chief Financial Officer (CFO). Ms. Bonstein will continue to serve as CFO until October 30, 2026, to ensure a smooth transition through the Company's reporting of its third-quarter 2026 financial results and she will participate in the earnings call on Thursday, October 29, 2026. Insmed has commenced a search to identify the Company's next CFO.

"We are grateful for Sara's many contributions over the past almost seven years and her dedicated leadership overseeing our finance organization during a time when Insmed raised more than $4.2 billion in capital," said Will Lewis, Chair and Chief Executive Officer of Insmed. "We are now well positioned to reach cash flow positivity next year with what we view as a clear path toward sustained top-line growth and bottom-line profitability." 

"Serving as Insmed's CFO has been a privilege of my career," said Ms. Bonstein. "I am thankful for our team and all we achieved together during my time with the Company. I am confident in Insmed's future, especially given our successful launch of BRINSUPRI coupled with our exciting pipeline. After considerable reflection, now is an ideal time for me to pursue my ambition for a broader leadership role."

Lewis continued, "Sara has been a steadfast partner in building Insmed into the company we are today, and we wish her well as she pursues her next leadership opportunity. Insmed has undergone a major transformation in recent years to become a global diversified biotech company with a robust portfolio of first- or best-in-class therapies with the potential to deliver meaningful impact for patients with serious diseases. With BRINSUPRI and ARIKAYCE on track to deliver meaningful revenue this year, and with substantial growth expected in the years ahead through our commercial portfolio and diverse therapeutic pipeline, we remain focused on delivering on our long-term ambitions. We are committed to ensuring our finance operations continue supporting Insmed's success in our next phase of growth, and we have partnered with a leading executive search firm to identify our next CFO."

Ms. Bonstein's transition is not related to any disagreement between Ms. Bonstein and the Company on any matter relating to the Company's accounting practices, financial statements, internal controls, or operations.

Reaffirms Full-Year 2026 Guidance

As Insmed continues to build on its operational excellence and momentum, the Company reaffirms its full-year 2026 financial guidance of revenue in the range of $1.25 billion to $1.40 billion for BRINSUPRI® (brensocatib) and $450 million to $470 million for ARIKAYCE® (amikacin liposome inhalation suspension).

Third-Quarter 2026 Earnings Conference Call

Insmed announced today that it will release its third-quarter 2026 financial results on Thursday, October 29, 2026.

Insmed management will host a conference call for investors beginning at 8:00 a.m. ET on Thursday, October 29, 2026, to discuss financial results and provide a business update.

Shareholders and other interested parties may participate in the conference call by dialing (833) 461-5787 (U.S.) and (585) 542-9983 (international) and referencing access code 603611044. The call will also be webcast live on the Company's website at www.insmed.com.

A replay of the conference call will be accessible approximately 2 hours after its completion through November 5, 2026, by dialing (833) 309-1852 (U.S.) and (929) 828-5978 (international) and referencing access code 603611044. A webcast of the call will also be archived for 90 days under the Investor Relations section of the Company's website at www.insmed.com.

About ARIKAYCE 

ARIKAYCE® is approved in the United States as ARIKAYCE (amikacin liposome inhalation suspension), in Europe as ARIKAYCE Liposomal 590 mg Nebuliser Dispersion, and in Japan as ARIKAYCE inhalation 590 mg (amikacin sulfate inhalation drug product). Current international treatment guidelines recommend the use of ARIKAYCE for appropriate patients. ARIKAYCE is a novel, inhaled, once-daily formulation of amikacin, an established antibiotic that was historically administered intravenously and associated with severe toxicity to hearing, balance, and kidney function. Insmed's proprietary PULMOVANCE™ liposomal technology enables the delivery of amikacin directly to the lungs, where liposomal amikacin is taken up by lung macrophages where the infection resides, while limiting systemic exposure. ARIKAYCE is administered once daily using the Lamira® Nebulizer System manufactured by PARI Pharma GmbH (PARI).

About PARI Pharma and the Lamira® Nebulizer System 

ARIKAYCE is delivered by a novel inhalation device, the Lamira® Nebulizer System, developed by PARI. Lamira® is a quiet, portable nebulizer that enables efficient aerosolization of ARIKAYCE via a vibrating, perforated membrane. Based on PARI's 100-year history working with aerosols, PARI is dedicated to advancing inhalation therapies by developing innovative delivery platforms to improve patient care.

BOXED WARNING AND IMPORTANT SAFETY INFORMATION FOR ARIKAYCE IN THE U.S.

WARNING: RISK OF INCREASED RESPIRATORY ADVERSE REACTIONSARIKAYCE has been associated with an increased risk of respiratory adverse reactions, including hypersensitivity pneumonitis, hemoptysis, bronchospasm, and exacerbation of underlying pulmonary disease that have led to hospitalizations in some cases.

Hypersensitivity Pneumonitis has been reported with the use of ARIKAYCE in the clinical trials. Hypersensitivity pneumonitis (reported as allergic alveolitis, pneumonitis, interstitial lung disease, allergic reaction to ARIKAYCE) was reported at a higher frequency in patients treated with ARIKAYCE plus background regimen (3.1%) compared to patients treated with a background regimen alone (0%). Most patients with hypersensitivity pneumonitis discontinued treatment with ARIKAYCE and received treatment with corticosteroids. If hypersensitivity pneumonitis occurs, discontinue ARIKAYCE and manage patients as medically appropriate.

Hemoptysis has been reported with the use of ARIKAYCE in the clinical trials. Hemoptysis was reported at a higher frequency in patients treated with ARIKAYCE plus background regimen (17.9%) compared to patients treated with a background regimen alone (12.5%). If hemoptysis occurs, manage patients as medically appropriate.

Bronchospasm has been reported with the use of ARIKAYCE in the clinical trials. Bronchospasm (reported as asthma, bronchial hyperreactivity, bronchospasm, dyspnea, dyspnea exertional, prolonged expiration, throat tightness, wheezing) was reported at a higher frequency in patients treated with ARIKAYCE plus background regimen (28.7%) compared to patients treated with a background regimen alone (10.7%). If bronchospasm occurs during the use of ARIKAYCE, treat patients as medically appropriate.

Exacerbations of underlying pulmonary disease has been reported with the use of ARIKAYCE in the clinical trials. Exacerbations of underlying pulmonary disease (reported as chronic obstructive pulmonary disease (COPD), infective exacerbation of COPD, infective exacerbation of bronchiectasis) have been reported at a higher frequency in patients treated with ARIKAYCE plus background regimen (14.8%) compared to patients treated with background regimen alone (9.8%). If exacerbations of underlying pulmonary disease occur during the use of ARIKAYCE, treat patients as medically appropriate.

Anaphylaxis and Hypersensitivity Reactions: Serious and potentially life-threatening hypersensitivity reactions, including anaphylaxis, have been reported in patients taking ARIKAYCE. Signs and symptoms include acute onset of skin and mucosal tissue hypersensitivity reactions (hives, itching, flushing, swollen lips/tongue/uvula), respiratory difficulty (shortness of breath, wheezing, stridor, cough), gastrointestinal symptoms (nausea, vomiting, diarrhea, crampy abdominal pain), and cardiovascular signs and symptoms of anaphylaxis (tachycardia, low blood pressure, syncope, incontinence, dizziness). Before therapy with ARIKAYCE is instituted, evaluate for previous hypersensitivity reactions to aminoglycosides. If anaphylaxis or a hypersensitivity reaction occurs, discontinue ARIKAYCE and institute appropriate supportive measures.

Ototoxicity has been reported with the use of ARIKAYCE in the clinical trials. Ototoxicity (including deafness, dizziness, presyncope, tinnitus, and vertigo) were reported with a higher frequency in patients treated with ARIKAYCE plus background regimen (17%) compared to patients treated with background regimen alone (9.8%). This was primarily driven by tinnitus (7.6% in ARIKAYCE plus background regimen vs 0.9% in the background regimen alone arm) and dizziness (6.3% in ARIKAYCE plus background regimen vs 2.7% in the background regimen alone arm). Closely monitor patients with known or suspected auditory or vestibular dysfunction during treatment with ARIKAYCE. If ototoxicity occurs, manage patients as medically appropriate, including potentially discontinuing ARIKAYCE.

Nephrotoxicity was observed during the clinical trials of ARIKAYCE in patients with MAC lung disease but not at a higher frequency than background regimen alone. Nephrotoxicity has been associated with the aminoglycosides. Close monitoring of patients with known or suspected renal dysfunction may be needed when prescribing ARIKAYCE.

Neuromuscular Blockade: Patients with neuromuscular disorders were not enrolled in ARIKAYCE clinical trials. Patients with known or suspected neuromuscular disorders, such as myasthenia gravis, should be closely monitored since aminoglycosides may aggravate muscle weakness by blocking the release of acetylcholine at neuromuscular junctions.

Embryo-Fetal Toxicity: Aminoglycosides can cause fetal harm when administered to a pregnant woman. Aminoglycosides, including ARIKAYCE, may be associated with total, irreversible, bilateral congenital deafness in pediatric patients exposed in utero. Patients who use ARIKAYCE during pregnancy, or become pregnant while taking ARIKAYCE should be apprised of the potential hazard to the fetus.

Contraindications: ARIKAYCE is contraindicated in patients with known hypersensitivity to any aminoglycoside.

Most Common Adverse Reactions: The most common adverse reactions in Trial 1 at an incidence ≥5% for patients using ARIKAYCE plus background regimen compared to patients treated with background regimen alone were dysphonia (47% vs 1%), cough (39% vs 17%), bronchospasm (29% vs 11%), hemoptysis (18% vs 13%), ototoxicity (17% vs 10%), upper airway irritation (17% vs 2%), musculoskeletal pain (17% vs 8%), fatigue and asthenia (16% vs 10%), exacerbation of underlying pulmonary disease (15% vs 10%), diarrhea (13% vs 5%), nausea (12% vs 4%), pneumonia (10% vs 8%), headache (10% vs 5%), pyrexia (7% vs 5%), vomiting (7% vs 4%), rash (6% vs 2%), decreased weight (6% vs 1%), change in sputum (5% vs 1%), and chest discomfort (5% vs 3%).

Drug Interactions: Avoid concomitant use of ARIKAYCE with medications associated with neurotoxicity, nephrotoxicity, and ototoxicity. Some diuretics can enhance aminoglycoside toxicity by altering aminoglycoside concentrations in serum and tissue. Avoid concomitant use of ARIKAYCE with ethacrynic acid, furosemide, urea, or intravenous mannitol.

Overdosage: Adverse reactions specifically associated with overdose of ARIKAYCE have not been identified. Acute toxicity should be treated with immediate withdrawal of ARIKAYCE, and baseline tests of renal function should be undertaken. Hemodialysis may be helpful in removing amikacin from the body. In all cases of suspected overdosage, physicians should contact the Regional Poison Control Center for information about effective treatment.

U.S. INDICATION 

LIMITED POPULATION: ARIKAYCE® is indicated in adults, who have limited or no alternative treatment options, for the treatment of Mycobacterium avium complex (MAC) lung disease as part of a combination antibacterial drug regimen in patients who do not achieve negative sputum cultures after a minimum of 6 consecutive months of a multidrug background regimen therapy. As only limited clinical safety and effectiveness data for ARIKAYCE are currently available, reserve ARIKAYCE for use in adults who have limited or no alternative treatment options. This drug is indicated for use in a limited and specific population of patients.

This indication is approved under accelerated approval based on achieving sputum culture conversion (defined as 3 consecutive negative monthly sputum cultures) by Month 6. Clinical benefit has not yet been established. Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trials.

Limitation of Use:

ARIKAYCE has only been studied in patients with refractory MAC lung disease defined as patients who did not achieve negative sputum cultures after a minimum of 6 consecutive months of a multidrug background regimen therapy. The use of ARIKAYCE is not recommended for patients with non-refractory MAC lung disease.

Patients are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch, or call 1‑800‑FDA‑1088. You can also call the Company at 1-844-4-INSMED.

Please see Full Prescribing Information. 

About Insmed

Insmed Incorporated is a people-first global biopharmaceutical company striving to deliver first- and best-in-class therapies to transform the lives of patients facing serious diseases. The Company is advancing a diverse portfolio of approved and mid- to late-stage investigational medicines — including two approved therapies to treat chronic, debilitating lung diseases — as well as cutting-edge drug discovery focused on serving patient communities where the need is greatest. Insmed's commercial portfolio and clinical pipeline are organized around three therapeutic areas: Respiratory, Immunology & Inflammation, and Neuro & Other Rare. The Company's research engine is advancing a wide range of technologies and modalities, including gene therapy, AI-driven protein engineering, RNA end-joining, and synthetic rescue, in the pursuit of future pipeline candidates.

Headquartered in Bridgewater, New Jersey, Insmed has offices and research locations throughout the United States, Europe, and Japan. Insmed is proud to be recognized as one of the best employers in the biopharmaceutical industry, including spending five consecutive years as the No. 1 Science Top Employer. Visit www.insmed.com to learn more or follow us on LinkedIn, Instagram, YouTube, and X.

Forward-Looking Statements 

This press release contains forward-looking statements that involve substantial risks and uncertainties. "Forward-looking statements," as that term is defined in the Private Securities Litigation Reform Act of 1995, are statements that are not historical facts and involve a number of risks and uncertainties. Words herein such as "may," "will," "should," "could," "would," "expects," "plans," "anticipates," "believes," "estimates," "projects," "predicts," "intends," "potential," "continues," and similar expressions (as well as other words or expressions referencing future events, conditions or circumstances) may identify forward-looking statements.

The forward-looking statements in this press release are based upon the Company's current expectations and beliefs, and involve known and unknown risks, uncertainties and other factors, which may cause the Company's actual results, performance and achievements and the timing of certain events to differ materially from the results, performance, achievements or timings discussed, projected, anticipated or indicated in any forward-looking statements. Such risks, uncertainties and other factors include, among others, the following: failure to continue to successfully commercialize ARIKAYCE in the U.S., Europe, or Japan or failure to successfully commercialize BRINSUPRI in the U.S., Europe, or Japan, or to maintain U.S., European, or Japanese approval for ARIKAYCE or BRINSUPRI; our inability to obtain full approval of ARIKAYCE from the FDA or our failure to obtain regulatory approval to expand ARIKAYCE's indication to a broader patient population; failure to obtain, or delays in obtaining, regulatory approvals for our product candidates in the U.S., Europe or Japan, for ARIKAYCE outside of the U.S., Europe, and Japan, including separate regulatory approval for the Lamira® Nebulizer System in each market and for each usage, or for BRINSUPRI outside of the U.S., Europe, and Japan; failure to successfully commercialize our product candidates, if approved by applicable regulatory authorities, or to maintain applicable regulatory approvals for such product candidates, if approved; uncertainties or changes in the degree of market acceptance of our marketed products or, if approved, our product candidates, by physicians, patients, third-party payors and others in the healthcare community; our inability to obtain and maintain adequate reimbursement from government or third-party payors for our marketed products or, if approved, our product candidates, or acceptable prices for our marketed products or, if approved, our product candidates; inaccuracies in our peak sales estimates for our marketed products and our product candidates; inaccuracies in our estimates of the size of the potential markets for our marketed products and our product candidates or in data we have used to identify physicians, expected rates of patient uptake, duration of expected treatment, or expected patient adherence or discontinuation rates; failure of third parties on which we are dependent to manufacture sufficient quantities of our marketed products and our product candidates for commercial or clinical needs, as applicable, to conduct our clinical trials, or to comply with our agreements or laws and regulations that impact our business; risks and uncertainties associated with, and the perceived benefits of, our senior secured loan with certain funds managed by Pharmakon Advisors, LP and our royalty financing with OrbiMed Royalty & Credit Opportunities IV, LP, including our ability to maintain compliance with the covenants in the agreements for the senior secured loan and royalty financing and the impact of the restrictions on our operations under these agreements; our inability to create or maintain an effective direct sales and marketing infrastructure or to partner with third parties that offer such an infrastructure for distribution of our marketed products or any of our product candidates that are approved in the future; failure to successfully conduct future clinical trials for our marketed products or our product candidates and our potential inability to enroll or retain sufficient patients to conduct and complete the trials or generate data necessary for regulatory approval of our product candidates; development of unexpected safety or efficacy concerns related to our marketed products or our product candidates; risks that our clinical studies will be delayed, that serious side effects will be identified during drug development, or that any protocol amendments submitted will be rejected; failure to successfully predict the time and cost of development, regulatory approval and commercialization for novel gene therapy products; risk that interim, topline or preliminary data from our clinical trials that we announce or publish from time to time may change as more patient data become available or may be interpreted differently if additional data are disclosed, or that blinded data will not be predictive of unblinded data; risk that our competitors may obtain orphan drug exclusivity for a product that is essentially the same as a product we are developing for a particular indication; our inability to attract and retain key personnel or to effectively manage our growth; our inability to successfully integrate our acquisitions and appropriately manage the amount of management's time and attention devoted to integration activities; risks that our acquired technologies, products and product candidates will not be commercially successful; inability to adapt to our highly competitive and changing environment; inability to access, upgrade or expand our technology systems or difficulties in updating our existing technology or developing or implementing new technology; risk that we are unable to maintain our significant customers; risk that healthcare legislation or other government action materially adversely affects our business; business or economic disruptions due to catastrophes or other events, including natural disasters or public health crises; risk that our current and potential future use of AI and machine learning may not be successful; deterioration in general economic conditions in the U.S., Europe, Japan and globally, including the effect of prolonged periods of inflation, affecting us, our suppliers, third-party service providers and potential partners; risk that we could become involved in costly intellectual property disputes, be unable to adequately protect our intellectual property rights or prevent disclosure of our trade secrets and other proprietary information, and incur costs associated with litigation or other proceedings related to such matters; restrictions or other obligations imposed on us by agreements related to our marketed products or our product candidates, including our license agreements with PARI and AstraZeneca AB, and failure to comply with our obligations under such agreements; the cost and potential reputational damage resulting from litigation to which we are or may become a party, including product liability claims; risk that our operations are subject to a material disruption in the event of a cybersecurity attack or issue; changes in laws and regulations applicable to our business, including any pricing reform and laws that impact our ability to utilize certain third parties in the research, development or manufacture of our product candidates, and failure to comply with such laws and regulations; our history of operating losses, and the possibility that we never achieve or maintain profitability; goodwill impairment charges affecting our results of operations and financial condition; inability to repay our existing indebtedness and uncertainties with respect to our ability to access future capital; and delays in the execution of plans to build out an additional third-party manufacturing facility approved by the appropriate regulatory authorities and unexpected expenses associated with those plans.

The Company may not actually achieve the results, plans, intentions or expectations indicated by the Company's forward-looking statements because, by their nature, forward-looking statements involve risks and uncertainties because they relate to events and depend on circumstances that may or may not occur in the future. For additional information about the risks and uncertainties that may affect the Company's business, please see the factors discussed in Item 1A, "Risk Factors," in the Company's Annual Report on Form 10-K for the year ended December 31, 2025 and any subsequent Company filings with the Securities and Exchange Commission (SEC).

The Company cautions readers not to place undue reliance on any such forward-looking statements, which speak only as of the date of this press release. The Company disclaims any obligation, except as specifically required by law and the rules of the SEC, to publicly update or revise any such statements to reflect any change in expectations or in events, conditions or circumstances on which any such statements may be based, or that may affect the likelihood that actual results will differ from those set forth in the forward-looking statements.

Contact:

Investors:
Sara Bonstein
Chief Financial Officer
[email protected]

Media:
Claire Mulhearn
Vice President, Corporate Communications
[email protected]

SOURCE Insmed Incorporated

15.19K Followers

Analyst’s Disclosure: I/we have no stock, option or similar derivative position in any of the companies mentioned, but may initiate a beneficial Long position through a purchase of the stock, or the purchase of call options or similar derivatives in INSM over the next 72 hours. I wrote this article myself, and it expresses my own opinions. I am not receiving compensation for it (other than from Seeking Alpha). I have no business relationship with any company whose stock is mentioned in this article.

Seeking Alpha's Disclosure: Past performance is no guarantee of future results. No recommendation or advice is being given as to whether any investment is suitable for a particular investor. Any views or opinions expressed above may not reflect those of Seeking Alpha as a whole. Seeking Alpha is not a licensed securities dealer, broker or US investment adviser or investment bank. Our analysts are third party authors that include both professional investors and individual investors who may not be licensed or certified by any institute or regulatory body.

Company-wide day of service brings together more than 1,350 employees to support over 50 organizations throughout the U.S., Europe, and Japan

, /PRNewswire/ -- Insmed Incorporated (Nasdaq: INSM), a people-first global biopharmaceutical company striving to deliver first- and best-in-class therapies to transform the lives of patients facing serious diseases, today holds its fifth annual Global Day of Good, a company-wide day of service during which employees volunteer simultaneously in their respective communities around the world. 

This year's day of service is the Company's largest and most far-reaching yet, with 1,350 employees across the U.S., Europe, and Japan participating in 50 activities benefiting more than 50 nonprofit organizations. Team members will support initiatives focused on health, education, and human services.

"At Insmed, giving back is woven into who we are as a company, and it's a commitment that only grows stronger with time," said Nicole Schaeffer, Chief People Strategy Officer of Insmed. "Reflecting back to our inaugural Global Day of Good in 2022, which brought together 500 employees, it's humbling to think about how far we have come and the meaningful difference we continue to make in the communities where we live and work. As we celebrate this fifth anniversary, I'm incredibly proud of how this event has evolved and grateful for the community relationships that have helped make it possible."

Over the past five years, Insmed employees have logged approximately 15,000 volunteer hours through Global Day of Good, supporting hundreds of nonprofits across the globe.

In the U.S., volunteer projects this year include assembling science, technology, engineering, and mathematics (STEM) kits for students, packing and preparing meals at local food banks, supporting environmental stewardship through beach cleanups and trail maintenance, creating care packages for children with serious diseases, and more. In Europe and Japan, Insmed team members will support a variety of activities, including translating children's books, participating in wellbeing workshops with local students, and refurbishing bicycles for individuals in need. With both remote and in-person activities available, all employees have the opportunity to give back, no matter where they are in the world.  

"Students 2 Science is proud to be one of the many nonprofits Insmed is supporting during their fifth annual Global Day of Good," said Dan Barnett, Executive Director of Students 2 Science. "We're excited to welcome volunteers to our Whippany, NJ, headquarters and continue creating meaningful learning opportunities for students. Initiatives like this demonstrate the power of community collaboration and the impact organizations can have when they come together in service of others."

Global Day of Good is one of the many ways that Insmed supports its local communities throughout the year. In addition to this annual day of service, the Company offers year-round volunteer opportunities, matching gift programs, paid time off to volunteer, and philanthropic engagements. To learn more about Insmed's commitment to corporate responsibility, read our 2025 Responsibility Report here.

About Insmed
Insmed Incorporated is a people-first global biopharmaceutical company striving to deliver first- and best-in-class therapies to transform the lives of patients facing serious diseases. The Company is advancing a diverse portfolio of approved and mid- to late-stage investigational medicines — including two approved therapies to treat chronic, debilitating lung diseases — as well as cutting-edge drug discovery focused on serving patient communities where the need is greatest. Insmed's commercial portfolio and clinical pipeline are organized around three therapeutic areas: Respiratory, Immunology & Inflammation, and Neuro & Other Rare. The Company's research engine is advancing a wide range of technologies and modalities, including gene therapy, AI-driven protein engineering, RNA end-joining, and synthetic rescue, in the pursuit of future pipeline candidates.

Headquartered in Bridgewater, New Jersey, Insmed has offices and research locations throughout the United States, Europe, and Japan. Insmed is proud to be recognized as one of the best employers in the biopharmaceutical industry, including spending five consecutive years as the No. 1 Science Top Employer. Visit www.insmed.com to learn more or follow us on LinkedIn, Instagram, YouTube, and X. 

Contact:

Investors:
Sara Bonstein
Chief Financial Officer
[email protected]

Media:
Claire Mulhearn
Vice President, Corporate Communications
[email protected]

SOURCE Insmed Incorporated

Insmed Incorporated (INSM) Presents at 12th Annual Cantor Fitzgerald Global Healthcare Conference Transcript

, /PRNewswire/ -- Insmed Incorporated (Nasdaq: INSM), a people-first global biopharmaceutical company striving to deliver first- and best-in-class therapies to transform the lives of patients facing serious diseases, today announced the granting of inducement awards to 128 new employees. The awards were granted under the Insmed Incorporated 2025 Inducement Plan, which is intended to meet the requirements of a plan providing for inducement grants under Nasdaq Listing Rule 5635(c)(4). The awards were approved by Insmed's Compensation Committee and made as a material inducement to each employee's entry into employment with the Company.

In connection with the commencement of their employment, on August 31, 2026, the employees received 115,320 restricted stock units and options to purchase an aggregate 5,560 shares of Insmed common stock at an exercise price of $121.82 per share, the closing trading price on the Nasdaq Global Select Market on the date of grant.

The restricted stock units have a four-year vesting schedule, with 25% of the shares underlying each restricted stock unit grant vesting on each anniversary of the first day of the month immediately following the grant date, subject to the relevant employee's continued service with Insmed on the applicable vesting date.

The options have a 10-year term and a four-year vesting schedule, with 25% of the shares subject to the option vesting on the first anniversary of the first day of the month immediately following the grant date and 12.5% of the shares subject to the option vesting every six months thereafter through the fourth anniversary thereof, subject to the relevant employee's continued service with Insmed on the applicable vesting date.

About Insmed

Insmed Incorporated is a people-first global biopharmaceutical company striving to deliver first- and best-in-class therapies to transform the lives of patients facing serious diseases. The Company is advancing a diverse portfolio of approved and mid- to late-stage investigational medicines — including two approved therapies to treat chronic, debilitating lung diseases — as well as cutting-edge drug discovery focused on serving patient communities where the need is greatest. Insmed's commercial portfolio and clinical pipeline are organized around three therapeutic areas: Respiratory, Immunology & Inflammation, and Neuro & Other Rare. The Company's research engine is advancing a wide range of technologies and modalities, including gene therapy, AI-driven protein engineering, RNA end-joining, and synthetic rescue, in the pursuit of future pipeline candidates.

Headquartered in Bridgewater, New Jersey, Insmed has offices and research locations throughout the United States, Europe, and Japan. Insmed is proud to be recognized as one of the best employers in the biopharmaceutical industry, including spending five consecutive years as the No. 1 Science Top Employer. Visit www.insmed.com to learn more or follow us on LinkedIn, Instagram, YouTube, and X.

Contact:

Investors:

Sara Bonstein
Chief Financial Officer
[email protected]

Media:

Claire Mulhearn
Vice President, Corporate Communications
[email protected] 

SOURCE Insmed Incorporated

Billionaire Stanley Druckenmiller, who runs the Duquesne Family Office hedge fund, has been loading up on healthcare stocks. A year ago, healthcare stocks represented almost 22% of the fund's portfolio. Today, that representation is up to more than 36%.

His fund's top holding is Natera (NTRA -3.67%), a cell-free DNA (cfDNA) testing company that represents about 17% of the fund's portfolio. In the second quarter, Duquesne bought an additional 122,700 shares of Natera.

The fund concentrates capital in high-conviction biotech and medtech bets while rotating in and out of cyclical stocks. Here's a glimpse into Duquesne's strategy.

Image source: Getty Images.

Druckenmiller likes noncyclical monopolies Unlike standard sector exchange-traded funds (ETFs) that track broad pharmaceutical companies, Duquesne concentrates its capital allocation in biotech and diagnostic companies with proprietary technology. Natera has consistently been Duquesne's largest holding. The thesis for the stock relies on Natera's dominant market position in cell-free DNA testing, particularly for oncology and women's health, which benefits from secular tailwinds in early cancer detection and high regulatory barriers to entry.

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The company's revenue is rising and the bottom line is getting closer to profitability. In the second quarter, it reported revenue of $752.8 million, up 38%, year over year. Gross margin rose by 110 basis points to 64.5% compared to the same quarter a year ago and by 50 basis points over the previous quarter. Natera is also seeing more testing volume, processing 1.044 billion tests, up 22%, year over year.

It reported an earnings per share (EPS) loss of $0.47, compared with a loss of $0.74 in the same quarter a year ago.

Based on its results, Natera says it expects yearly revenue of $2.85 billion to $2.91 billion, up 321% at the midpoint, and for the company to finish the year cash flow positive.

A focus on niche, catalyst-driven biotech companies Duquesne often adds smaller, clinical-stage, or specialty biotechs operating in underserved markets with low competition. The fund's biggest buy in the second quarter was a 270,600-share purchase of Insmed (INSM -2.35%), a biotech company focused on pulmonary therapeutics and rare diseases. The company reported second-quarter revenue of $425.5 million, up 296%, year over year. It also narrowed its EPS loss to $0.06 from $1.70 in the same quarter a year ago.

Insmed has two commercial therapies: Brinsupri, a non-cystic fibrosis bronchiectasis treatment that saw revenue rise by 49% in the first quarter, and Arikayce, which reported an 8% year-over-year sales gain. It is an inhalation therapy to treat Mycobacterium avium complex lung disease.

The company also holds 203,600 shares in Rhythm Pharmaceuticals (RYTM -4.76%), a biotech targeting the genetic causes of rare obesity. The company provides upside exposure to the powerful anti-obesity theme without competing directly head-to-head against weight-loss giants Eli Lilly (LLY -0.13%) or Novo Nordisk (NVO -1.41%).

Rhythm's lead product is Imcivree, which in March received approval from the Food and Drug Administration for a new indication: treating acquired hypothalamic obesity, a rare condition caused by injury or dysfunction of the hypothalamus that leads to weight gain. It is also developing setmelanotide, which is in phase 3 clinical trials for treating acquired or congenital hypothalamic obesity, as well as treating pro-opiomelanocortin receptor deficiency obesity or leptin receptor deficiency obesity, plus SRC1 deficiency obesity and SH2B1 deficiency obesity.

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Healthcare demand is somewhat protected Healthcare offers structural demand insulated from standard economic growth cycles. When trim signals hit broader tech, industrial, or semiconductor plays, highly specialized biotech stocks act as an uncorrelated growth venue that doesn't rely on macro gross domestic product strength to drive gains.

Duquesne does not passively accumulate the entire sector; it actively trades healthcare cycles. For example, earlier filings showed trimming and exiting legacy pharmaceutical positions to concentrate capital in diagnostic and specialty biotech businesses, such as Natera and Insmed, while rotating tactical macro capital into financials or semiconductor recovery plays, depending on global economic conditions.

As of the company's latest 13F filing on Aug. 14, the fund reported a one-year return of more than 34%, compared to the S&P 500's (^GSPC -0.25%) return of slightly more than 20% during that same period. Actively managed funds such as Duquesne can entail greater risk alongside higher potential upside.

Key Takeaways Liquidia's Yutrepia sales surged, driving its fourth consecutive profitable quarter.Insmed raised Brinsupri's 2026 revenue guidance to $1.25-$1.40 billion.Insmed's broader pipeline and diversified revenue base may support a more sustainable growth story. Liquidia Corporation (LQDA - Free Report) and Insmed (INSM - Free Report) are both commercial-stage biopharmaceutical companies with a focus on developing innovative treatments for serious diseases.

LQDA is focused on developing and commercializing therapies for pulmonary arterial hypertension (PAH) and pulmonary hypertension associated with interstitial lung disease (PH-ILD), while Insmed is focused on the development of therapies targeting serious and rare indications.

The key point of overlap between the two companies is their focus on inhaled therapies for pulmonary hypertension, making them particularly relevant for a growth-stock comparison.

Liquidia specifically identifies Insmed’s treprostinil palmitil inhalation powder (TPIP) as a potential competitor to Yutrepia, with phase III studies underway.

Against this backdrop, choosing between the two stocks can be challenging. We therefore compare their fundamentals, growth prospects, potential challenges and valuation metrics to determine which stock offers the more compelling investment opportunity.

The Case for LQDALaunched in June 2025, LQDA’s Yutrepia was approved by the FDA in May 2025 for the treatment of both PAH and PH-ILD.

The drug is an inhaled dry-powder version of treprostinil made with the company’s proprietary PRINT technology, designed to deliver medicine deeper into the lungs through an easy-to-use inhaler and allow higher doses than other inhaled treprostinil treatments.

Yutrepia’s net product sales reached $170.4 million in the second quarter, up from $6.5 million a year earlier, driven by higher volume.

Yutrepia appears to be gaining market share while expanding the inhaled prostacyclin market. As of July 31, 2026, Liquidia had received approximately 5,900 unique prescriptions since launch and started more than 5,000 patients on therapy. As of the aforementioned date, more than 1,100 physicians had prescribed Yutrepia since its launch, with more than 30% having written prescriptions for at least five patients. The prescription-to-start conversion rate remained above 85%.

Strong Yutrepia sales helped drive the company's fourth consecutive profitable quarter, with net income reaching $74.7 million in the second quarter.

Liquidia currently generates revenues from sales of Yutrepia inhalation powder, and through a profit-sharing arrangement with Sandoz under a promotion agreement originally signed in August 2018 and subsequently amended. The agreement allows Liquidia to share in the profits generated from sales of Sandoz's generic treprostinil Injection in the United States.

LQDA plans to explore Yutrepia in additional indications, including pulmonary hypertension associated with chronic obstructive pulmonary disease, idiopathic pulmonary fibrosis (IPF) progressive pulmonary fibrosis (PPF) and Raynaud’s phenomenon associated with systemic sclerosis.

Liquidia is leveraging its expertise in respiratory and vascular diseases to advance a pipeline of novel therapies that could support long-term growth. A key pipeline asset is L606, an investigational liposomal formulation of treprostinil licensed from Pharmosa Biopharm, designed for twice-daily administration using a short-duration, next-generation nebulizer. It is also being evaluated in PAH and PH-ILD. The phase III Re-Spire study on L606 is currently enrolling.

The Case for INSMInsmed’s portfolio includes two commercial products — Arikayce and Brinsupri.

Arikayce is indicated for the treatment of refractory mycobacterium avium complex lung disease as part of a combination antibacterial drug regimen in adult patients with limited or no alternative treatment options. The drug is also approved for a similar indication in Europe and Japan.

Insmed’s portfolio received a significant boost with the FDA approval of Brinsupri (brensocatib) in 2025. The drug is an oral, once-daily treatment for non-cystic fibrosis bronchiectasis (referred to as bronchiectasis or NCFB) in patients 12 years of age and older. The drug also received approval in the EU in November 2025.

Brinsupri’s initial market uptake has been strong. Insmed raised its full-year 2026 revenue guidance for the drug to $1.25-$1.40 billion from its previous forecast of at least $1 billion.

Insmed is also advancing several clinical-stage programs in respiratory diseases, including TPIP and INS1148.

TPIP is an inhaled dry powder formulation of the treprostinil prodrug treprostinil palmitil, which may offer a differentiated product profile for PH-ILD, PAH, PPF and IPF.

The company has made encouraging progress with the program. Insmed is currently enrolling patients in the PALM-ILD trial, a phase III study of TPIP in patients with PH-ILD. It is also actively enrolling patients in the PALM-PAH trial, a phase III study of TPIP in patients with PAH.

Last month, the company reported positive 12-month data from the ongoing open-label extension study of TPIP in patients with PAH.

The company also plans to initiate a phase III study of TPIP in patients with PPF in the second half of 2026, followed by a phase III study in IPF in the first half of 2027.

Insmed is advancing INS1148 in a phase II program initially focused on PPF and IPF. The company is also exploring additional diseases where inhibiting the inflammatory functions of Stem Cell Factor 248 (SCF248) could provide therapeutic benefits.

Beyond respiratory diseases, Insmed is evaluating INS1201, an intrathecally delivered gene therapy for Duchenne muscular dystrophy, and INS1202, an intrathecally delivered gene therapy for amyotrophic lateral sclerosis.

A Look at Estimates: LQDA vs INSMThe Zacks Consensus Estimate for LQDA’s 2026 sales implies a year-over-year increase of 340.72%, while that for earnings per share (EPS) suggests a year-over-year improvement of 421.25%.

The Zacks Consensus Estimate for 2026 EPS has moved south to $2.57 from $2.97 and that for 2027 EPS has decreased to $4.38 from $4.81 in the past 60 days.

LQDA’s Estimate Movement
Image Source: Zacks Investment Research

The Zacks Consensus Estimate for INSM’s 2026 sales implies a year-over-year increase of 194.19%, while that for EPS suggests a year-over-year increase of 74.14%.  Loss estimates for 2026 have improved to $1.66 from $2.63 in the past 60 days. EPS estimates for 2027 have moved north to $2.61 from 89 cents during the said time frame.

INSM’s Estimate Movement
Image Source: Zacks Investment Research

Price Performance and Valuation of LQDA and INSMFrom a price-performance perspective, LQDA has fetched better returns than INSM so far this year. Shares of LQDA have surged 106.9%, while those of INSM have lost 28.5%. The industry has gained 12.6% in the said period.

Image Source: Zacks Investment Research

From a valuation standpoint, INSM is more expensive than LQDA. LQDA’s shares currently trade at 6.53X forward sales, lower than 10.65X for INSM.

Image Source: Zacks Investment Research

Which Stock Is a Better Pick for Now?Since both LQDA and INSM stocks currently carry a Zacks Rank #3 (Hold), choosing one over the other could be tricky. You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.

Liquidia stands out for its impressive commercial momentum. Yutrepia’s rapid uptake has driven strong revenue growth and profitability, while its potential expansion into additional indications provides further upside. LQDA also trades at a lower forward-sales multiple than INSM. However, the company remains heavily reliant on Yutrepia, and competition from emerging inhaled therapies represents a key risk. The downward revisions to EPS estimates also warrant caution.

INSM offers a more diversified growth story. Brinsupri’s strong launch and higher-than-expected 2026 revenue guidance provide a solid commercial foundation, while Arikayce adds an established revenue stream. Insmed has a broader pipeline, with TPIP potentially expanding the company’s presence in the pulmonary hypertension market and additional programs targeting PPF, IPF and other serious diseases.

Although INSM is more expensive on a forward-sales basis and its shares have significantly underperformed LQDA this year, its broader commercial base and deeper pipeline reduce its reliance on a single product. Continued execution on Brinsupri and positive clinical progress with TPIP could provide additional catalysts.

Hence, we believe INSM’s diversified revenue base, strong Brinsupri opportunity and broader pipeline make it the more compelling choice for investors seeking a more sustainable long-term growth story.

Key Takeaways Insmed beat Q2 revenue and earnings estimates as Brinsupri and Arikayce sales topped expectations.INSM raised 2026 Brinsupri revenue guidance to $1.25-$1.40 billion after strong organic patient uptake.Insmed increased peak sales targets for Brinsupri and TPIP while maintaining 2027 cash-flow positivity goal. Insmed (INSM - Free Report) reported an adjusted loss of 52 cents per share in the second quarter of 2026, narrower than the Zacks Consensus Estimate of a loss of 69 cents.

The adjusted figure excluded a non-cash gain of $99.8 million tied to a change in the fair value of contingent consideration liabilities. Including this item, the reported loss was 6 cents per share. The company had incurred a loss of $1.70 per share in the year-ago quarter.

Quarterly revenues soared 296% year over year to $425.5 million, entirely from the sales of its two marketed products. The reported figure beat the Zacks Consensus Estimate of $389.7 million.

Shares of Insmed jumped 34% yesterday following the earnings announcement. The stock's upside was driven by strong organic patient uptake of Brinsupri during the quarter, prompting management to significantly raise its sales guidance.

Year to date, the stock has lost 24% against the industry’s nearly 4% growth.

Image Source: Zacks Investment Research

INSM’s Product Revenues Top ExpectationsInsmed currently has two marketed drugs, Arikayce and Brinsupri, in its portfolio. While Arikayce is approved to treat refractory mycobacterium avium complex (MAC) lung disease in adults with limited or no treatment options, Brinsupri is approved for non-cystic fibrosis bronchiectasis (NCFB).

Sales of Arikayce rose 8% year over year to $116.3 million, driven by strong growth across ex-U.S. markets. The metric also beat the Zacks Consensus Estimate of $113.9 million.

This was the third full quarter in which Insmed generated revenues from Brinsupri sales since its approval in August 2025. The drug contributed $309.2 million to the top line during the quarter, up from $207.9 million in the previous quarter. The reported figure also surpassed the Zacks Consensus Estimate of $275.8 million.

Around 7,000 new patients started Brinsupri during the quarter, ahead of management's prior expectation of approximately 6,300. Importantly, management stated that all these patient starts represented organic demand, with no contribution from the "ready and waiting" patient pool — those who were already aware of the drug before approval and began treatment quickly once it became available. Insmed expects roughly 7,000 new patient starts per quarter through the remainder of 2026.

Management also noted favorable payer access for Brinsupri, with an approximately 90% approval rate and approvals taking less than a week for most patients. Persistence and other patient-use metrics remained at or ahead of Insmed's internal benchmarks, supporting confidence in the growth trajectory.

INSM’s Operating Expenses RiseResearch and development expenses rose 18.5% year over year to $210 million. The increase was primarily caused by higher employee-related costs and increased clinical development expenses.

Selling, general and administrative expenses climbed 60% year over year to $247.5 million. Higher professional fees, external costs and employee-related expenses associated with Brinsupri commercial activities led to the increase.

As of June 30, 2026, Insmed had cash, cash equivalents and marketable securities of around $1.2 billion, in line with the previous quarter’s level.

INSM Raises Brinsupri Sales GuidanceFollowing the stronger-than-expected launch, Insmed raised its 2026 Brinsupri revenue guidance to $1.25-$1.40 billion from its previous expectation of at least $1 billion.

The company also increased its estimated global peak sales for Brinsupri to more than $7 billion from the previous guidance of over $5 billion. Management cited expectations for growth in the addressable bronchiectasis market through improved diagnosis and greater disease awareness.

Insmed maintained its 2026 Arikayce revenue guidance at $450-$470 million.

The company continues to expect to reach cash-flow positivity in 2027 without raising additional capital.

Updates on INSM’s PipelineLast month, Insmed submitted a regulatory filing with the FDA seeking to expand Arikayce's use to newly diagnosed patients with MAC lung disease. The company also plans discussions with Japanese regulators later this year to support a potential label expansion in Japan.

Insmed continues to advance its investigational treprostinil palmitil inhalation powder (TPIP) program across multiple pulmonary indications. The company is currently enrolling patients in separate late-stage studies for pulmonary hypertension associated with interstitial lung disease (PH-ILD) and pulmonary arterial hypertension (PAH).

The company remains on track to initiate two additional late-stage TPIP studies, one in progressive pulmonary fibrosis (PPF) in the second half of 2026 and another in idiopathic pulmonary fibrosis (IPF) in the first half of 2027.

Like Brinsupri, Insmed raised its peak sales estimate for TPIP to more than $6 billion from the previous guidance of over $2 billion. This reflects increased confidence following encouraging clinical data and the expansion of the program into additional indications.

INSM’s Zacks RankInsmed currently carries a Zacks Rank #3 (Hold).

Our Key Picks Among Biotech StocksSome better-ranked stocks in the biotech sector are Harmony Biosciences (HRMY - Free Report) and Liquidia Corporation (LQDA - Free Report) , each currently sporting a Zacks Rank #1 (Strong Buy). You can see the complete list of today’s Zacks #1 Rank stocks here.

Over the past 60 days, earnings per share (EPS) estimates for Harmony Biosciences have risen from $3.20 to $3.33 for 2026. Over the same period, EPS estimates have increased from $3.64 to $3.87 for 2027. HRMY shares have risen about 4% year to date.

Harmony Biosciences missed on earnings in three of the trailing four quarters and met on one occasion, delivering an average negative surprise of 13.97%.

Over the past 60 days, estimates for Liquidia’s 2026 EPS have increased to $3.02 from $2.97. Over the same period, EPS estimates for 2027 have risen from $4.81 to $5.31. LQDA shares have skyrocketed 159% so far this year.

Liquidia’s earnings beat estimates in three of the trailing four quarters and missed on one occasion, with the average surprise being 54.40%.

Insmed (INSM - Free Report) reported $425.49 million in revenue for the quarter ended June 2026, representing a year-over-year increase of 296.1%. EPS of -$0.52 for the same period compares to -$1.70 a year ago.

The reported revenue compares to the Zacks Consensus Estimate of $389.72 million, representing a surprise of +9.18%. The company delivered an EPS surprise of +24.64%, with the consensus EPS estimate being -$0.69.

While investors closely watch year-over-year changes in headline numbers -- revenue and earnings -- and how they compare to Wall Street expectations to determine their next course of action, some key metrics always provide a better insight into a company's underlying performance.

As these metrics influence top- and bottom-line performance, comparing them to the year-ago numbers and what analysts estimated helps investors project a stock's price performance more accurately.

Here is how Insmed performed in the just reported quarter in terms of the metrics most widely monitored and projected by Wall Street analysts:

Revenues- U.S.: $378.74 million versus the four-analyst average estimate of $334.1 million. The reported number represents a year-over-year change of +451.4%.Revenues- ARIKAYCE- International: $46.13 million compared to the $40.67 million average estimate based on four analysts.Revenues- ARIKAYCE- U.S.: $70.19 million versus $73.5 million estimated by four analysts on average.Revenues- International: $46.75 million compared to the $42.82 million average estimate based on four analysts. The reported number represents a change of +480% year over year.Revenues- ARIKAYCE- Total: $116.32 million compared to the $113.9 million average estimate based on seven analysts.Revenues- BRINSUPRI- Total: $309.17 million versus $275.82 million estimated by seven analysts on average.View all Key Company Metrics for Insmed here>>>

Shares of Insmed have returned -15% over the past month versus the Zacks S&P 500 composite's +3.3% change. The stock currently has a Zacks Rank #3 (Hold), indicating that it could perform in line with the broader market in the near term.

Insmed (INSM - Free Report) came out with a quarterly loss of $0.52 per share versus the Zacks Consensus Estimate of a loss of $0.69. This compares to a loss of $1.7 per share a year ago. These figures are adjusted for non-recurring items.

This quarterly report represents an earnings surprise of +24.64%. A quarter ago, it was expected that this biopharmaceutical developing inhaled treatments for patients battling rare lung diseases would post a loss of $0.9 per share when it actually produced a loss of $0.76, delivering a surprise of +15.56%.

Over the last four quarters, the company has surpassed consensus EPS estimates two times.

Insmed, which belongs to the Zacks Medical - Biomedical and Genetics industry, posted revenues of $425.49 million for the quarter ended June 2026, surpassing the Zacks Consensus Estimate by 9.18%. This compares to year-ago revenues of $107.42 million. The company has topped consensus revenue estimates two times over the last four quarters.

The sustainability of the stock's immediate price movement based on the recently-released numbers and future earnings expectations will mostly depend on management's commentary on the earnings call.

Insmed shares have lost about 43.1% since the beginning of the year versus the S&P 500's gain of 12.8%.

What's Next for Insmed?While Insmed has underperformed the market so far this year, the question that comes to investors' minds is: what's next for the stock?

There are no easy answers to this key question, but one reliable measure that can help investors address this is the company's earnings outlook. Not only does this include current consensus earnings expectations for the coming quarter(s), but also how these expectations have changed lately.

Empirical research shows a strong correlation between near-term stock movements and trends in earnings estimate revisions. Investors can track such revisions by themselves or rely on a tried-and-tested rating tool like the Zacks Rank, which has an impressive track record of harnessing the power of earnings estimate revisions.

Ahead of this earnings release, the estimate revisions trend for Insmed was mixed. While the magnitude and direction of estimate revisions could change following the company's just-released earnings report, the current status translates into a Zacks Rank #3 (Hold) for the stock. So, the shares are expected to perform in line with the market in the near future. You can see the complete list of today's Zacks #1 Rank (Strong Buy) stocks here.

It will be interesting to see how estimates for the coming quarters and the current fiscal year change in the days ahead. The current consensus EPS estimate is -$0.52 on $461.86 million in revenues for the coming quarter and -$2.43 on $1.69 billion in revenues for the current fiscal year.

Investors should be mindful of the fact that the outlook for the industry can have a material impact on the performance of the stock as well. In terms of the Zacks Industry Rank, Medical - Biomedical and Genetics is currently in the top 44% of the 250 plus Zacks industries. Our research shows that the top 50% of the Zacks-ranked industries outperform the bottom 50% by a factor of more than 2 to 1.

One other stock from the same industry, Eton Pharmaceuticals, Inc. (ETON - Free Report) , is yet to report results for the quarter ended June 2026. The results are expected to be released on August 13.

This company is expected to post quarterly earnings of $0.13 per share in its upcoming report, which represents a year-over-year change of +230%. The consensus EPS estimate for the quarter has remained unchanged over the last 30 days.

Eton Pharmaceuticals, Inc.'s revenues are expected to be $27.22 million, up 43.8% from the year-ago quarter.

Posted by Defense World Staff on Jul 29th, 2026

Bank of Nova Scotia reduced its position in Insmed, Inc. (NASDAQ:INSM – Free Report) by 75.0% during the 1st quarter, according to the company in its most recent filing with the Securities and Exchange Commission (SEC). The fund owned 15,203 shares of the biopharmaceutical company’s stock after selling 45,572 shares during the period. Bank of Nova Scotia’s holdings in Insmed were worth $2,486,000 at the end of the most recent quarter.

A number of other hedge funds and other institutional investors also recently made changes to their positions in INSM. EverSource Wealth Advisors LLC grew its stake in shares of Insmed by 65.6% in the 2nd quarter. EverSource Wealth Advisors LLC now owns 664 shares of the biopharmaceutical company’s stock valued at $67,000 after buying an additional 263 shares in the last quarter. First Trust Advisors LP lifted its stake in Insmed by 80.8% in the second quarter. First Trust Advisors LP now owns 47,392 shares of the biopharmaceutical company’s stock valued at $4,770,000 after acquiring an additional 21,176 shares during the last quarter. Baird Financial Group Inc. acquired a new stake in Insmed in the second quarter valued at approximately $2,589,000. Amundi grew its position in Insmed by 21,194.4% in the second quarter. Amundi now owns 11,499 shares of the biopharmaceutical company’s stock worth $1,130,000 after acquiring an additional 11,445 shares in the last quarter. Finally, Natixis bought a new stake in Insmed in the second quarter worth approximately $1,072,000.

Insiders Place Their Bets In other news, COO Roger Adsett sold 2,370 shares of Insmed stock in a transaction dated Wednesday, June 3rd. The stock was sold at an average price of $102.27, for a total value of $242,379.90. Following the transaction, the chief operating officer directly owned 98,603 shares in the company, valued at approximately $10,084,128.81. The trade was a 2.35% decrease in their ownership of the stock. The transaction was disclosed in a document filed with the SEC, which is accessible through this hyperlink. The sale was made to cover tax withholding obligations related to the vesting of equity awards. Also, CFO Sara Bonstein sold 2,404 shares of the business’s stock in a transaction dated Wednesday, June 3rd. The stock was sold at an average price of $102.27, for a total value of $245,857.08. Following the transaction, the chief financial officer directly owned 69,082 shares of the company’s stock, valued at $7,065,016.14. This represents a 3.36% decrease in their position. The disclosure for this sale is available in the SEC filing. The sale was made to cover tax withholding obligations related to the vesting of equity awards. In the last ninety days, insiders sold 54,590 shares of company stock valued at $5,793,738. 2.10% of the stock is owned by company insiders.

Insmed Price Performance NASDAQ INSM opened at $104.13 on Wednesday. The company has a current ratio of 4.47, a quick ratio of 4.10 and a debt-to-equity ratio of 0.80. The company has a fifty day simple moving average of $105.09 and a 200 day simple moving average of $132.25. The company has a market cap of $22.57 billion, a P/E ratio of -18.11 and a beta of 0.78. Insmed, Inc. has a 1 year low of $90.39 and a 1 year high of $212.75.

Insmed (NASDAQ:INSM – Get Free Report) last posted its earnings results on Thursday, May 7th. The biopharmaceutical company reported ($0.76) earnings per share (EPS) for the quarter, beating analysts’ consensus estimates of ($0.90) by $0.14. The business had revenue of $305.96 million for the quarter, compared to analyst estimates of $300.81 million. Insmed had a negative net margin of 144.44% and a negative return on equity of 130.11%. Insmed’s revenue was up 229.7% compared to the same quarter last year. During the same period last year, the business posted ($1.42) EPS. On average, sell-side analysts predict that Insmed, Inc. will post -2.43 EPS for the current year.

Wall Street Analysts Forecast Growth Several equities research analysts recently issued reports on the stock. Raymond James Financial began coverage on shares of Insmed in a research note on Friday, April 10th. They issued an “outperform” rating and a $200.00 price objective for the company. Cantor Fitzgerald reissued an “overweight” rating and set a $235.00 target price on shares of Insmed in a research report on Tuesday. Roth Capital restated a “buy” rating on shares of Insmed in a report on Monday, June 8th. Guggenheim reaffirmed a “buy” rating and issued a $207.00 price target on shares of Insmed in a research report on Friday, July 10th. Finally, HC Wainwright reiterated a “buy” rating and set a $220.00 price target on shares of Insmed in a research note on Monday, July 20th. Two research analysts have rated the stock with a Strong Buy rating, twenty-three have issued a Buy rating and one has given a Sell rating to the company’s stock. According to MarketBeat.com, Insmed presently has a consensus rating of “Buy” and an average target price of $209.35.

Read Our Latest Analysis on INSM

Insmed Profile (Free Report)

Insmed Incorporated is a biopharmaceutical company focused on developing and commercializing therapies for patients with rare and serious diseases, with a particular emphasis on difficult-to-treat pulmonary infections. Headquartered in Bridgewater, New Jersey, the company concentrates its research and development efforts on targeted drug delivery technologies and novel formulations intended to improve clinical outcomes for patients who have limited treatment options.

The company’s principal marketed product is ARIKAYCE (amikacin liposome inhalation suspension), an inhaled liposomal formulation of the antibiotic amikacin that is approved by the U.S.

Read More Five stocks we like better than Insmed These 3 Stocks Have Soared in 2026—Can They Keep Climbing? Hasbro’s Earnings Beat Shows Why This Is No Longer Just a Toy Story Rambus: Another AI Phoenix Ready to Rise From the Ashes of Correction Chips & Clips: Memory Tariffs Rewire Tech Supply Chains Want to see what other hedge funds are holding INSM? Visit HoldingsChannel.com to get the latest 13F filings and insider trades for Insmed, Inc. (NASDAQ:INSM – Free Report).

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, /PRNewswire/ -- Insmed Incorporated (Nasdaq: INSM), a people-first global biopharmaceutical company striving to deliver first- and best-in-class therapies to transform the lives of patients facing serious diseases, today announced that it will release its second-quarter 2026 financial results on Thursday, August 6, 2026.

Insmed management will host a conference call for investors beginning at 8:00 a.m. ET on Thursday, August 6, 2026, to discuss financial results and provide a business update.

Shareholders and other interested parties may participate in the conference call by dialing (888) 210-2654 (U.S.) and (646) 960-0278 (international) and referencing access code 7862189. The call will also be webcast live on the Company's website at www.insmed.com.

A replay of the conference call will be accessible approximately 1 hour after its completion through August 13, 2026, by dialing (800) 770-2030 (U.S.) and (609) 800-9909 (international) and referencing access code 7862189. A webcast of the call will also be archived for 90 days under the Investor Relations section of the Company's website at www.insmed.com.

About Insmed

Insmed Incorporated is a people-first global biopharmaceutical company striving to deliver first- and best-in-class therapies to transform the lives of patients facing serious diseases. The Company is advancing a diverse portfolio of approved and mid- to late-stage investigational medicines—including two approved therapies to treat chronic, debilitating lung diseases— as well as cutting-edge drug discovery focused on serving patient communities where the need is greatest. Insmed's commercial portfolio and clinical pipeline are organized around three therapeutic areas: Respiratory, Immunology & Inflammation, and Neuro & Other Rare. The Company's research engine is advancing a wide range of technologies and modalities, including gene therapy, AI-driven protein engineering, RNA end-joining, and synthetic rescue, in the pursuit of future pipeline candidates.

Headquartered in Bridgewater, New Jersey, Insmed has offices and research locations throughout the United States, Europe, and Japan. Insmed is proud to be recognized as one of the best employers in the biopharmaceutical industry, including spending five consecutive years as the No. 1 Science Top Employer. Visit www.insmed.com to learn more or follow us on LinkedIn, Instagram, YouTube, and X.

Contact:

Investors:
Bryan Dunn
Vice President, Investor Relations
(646) 812-4030
[email protected]

Media:
Claire Mulhearn
Vice President, Corporate Communications
(862) 842-6819
[email protected]

SOURCE Insmed Incorporated

© Chaay_Tee / iStock via Getty Images

Pre-Market Stock Futures: Futures are trading higher on Tuesday as traders anxiously await more positive earnings reports after a lower day on Wall Street, as chip stocks rebounded somewhat, and Iran, after 9 straight nights of U.S. attacks, had its foreign ministry indicate that discussions could be pursued further. That is a good idea, given that the Iranian government had also told citizens to limit their electricity use. When the smoke cleared on Monday, all four of the major indices closed lower. The Nasdaq closed at 25,508, down 0.05%, while the Dow Jones Industrial Average closed the session at 51,839, down 0.59%. The S&P 500 closed at 7,443, down 0.19%, while the small-cap Russell 2000 was the biggest loser, last seen at 2,942, down 0.67%. With earnings season now in full swing, all eyes will not only be on earnings but also on forward guidance. Any ambiguity in either could spell trouble for the reporting company.

Treasury Bonds: Yields were up across the Treasury curve, with the only buying in the shortest T-bill maturities. The mixed messages from Iran, along with the continued rise in oil prices, sparked renewed concerns about inflation. When trading ended, the 30-year bond closed at 5.11%, while the 10-year note closed at 4.59%.

Oil and Gas: Prices were higher across the energy complex, but not the drastic spike we saw there last week. The ongoing hostilities with Iran are the biggest fly in the ointment, with Iran launching strikes on its neighboring Arab countries, also helping to push prices higher. Brent Crude closed the session at $88.97, up 0.99%, while West Texas Intermediate closed the day at $82.45, up 0.82%. 

Gold: Precious metals were mixed as we opened the trading week. The ongoing geopolitical pressure and rising interest rates kept the bullion in check, as Gold closed the day at $4,005, down 0.60%, while Silver finished the day positive at $56.25, up 0.77%

Crypto: Cryptocurrencies posted modest gains on Monday as the broader market weighed ongoing inflation concerns against strength in tech and AI-related assets. Bitcoin rose about 1.4% to hit a one-month high of $65,400. Ethereum and other major altcoins, including XRP and Solana, followed with similar advances. Earlier in the day, Bitcoin traded in a narrower range between $64,200 and $64,700. At 8 AM EDT, Bitcoin was trading at $66,215, while Ethereum was quoted at $1,929.

24/7 Wall St. reviews dozens of analyst research reports every day to identify fresh investment ideas for investors and traders alike. These daily analyst notes include recommendations on stocks to buy, sell, or avoid, as well as new coverage initiations. Important reminder: No single analyst report should ever be the sole basis for buying or selling a stock.

Here are some of the top Wall Street analyst upgrades, downgrades, and initiations seen on Tuesday, July 21, 2026.  

Upgrades: Five Below (NASDAQ: FIVE | FIVE Price Prediction) was upgraded to Outperform from Market Perform at Bernstein, which nudged the target price for the popular retailer to $250 from $247. Fortinet (NASDAQ: FTNT) was raised to Equal Weight from Underweight at Morgan Stanley, which boosted the target price for the shares to $133 from $80. Goldman Sachs Group (NYSE: GS) was upgraded to Hold from Reduce at HSBC, with a $995 target price. Ralph Lauren (NYSE: RL) was upgraded to Outperform from Market Perform at Raymond James, with a $410 target price for the clothing and fragrance giant. UDR (NYSE: UDR) was upgraded to Buy from Hold at Deutsche Bank, which bumped the target price to $45 from $39. Downgrades: Adobe (NASDAQ: ADBE) was downgraded to Underweight from Equal Weight, which slashed the target price for the stock to $240 from $365. Apple Hospitality REIT (NASDAQ: APLE) was downgraded to Equal Weight from Overweight at Barclays, which bumped the target price for the stock to $17 from $16. Datadog (NASDAQ: DDOG) was cut to Hold from Buy at Jefferies, which actually raised the target price for the shares to $280 from $210. Gilead Sciences (NASDAQ: GILD) was downgraded to Market Perform from Outperform at Leerink, which cut the target price on the biotech giant to $127 from $146. Salesforce (NYSE: CRM) was cut to Equal Weight from Overweight at Morgan Stanley, which crashed the target price for the shares to $185 from $287. Initiations: American Healthcare REIT (NYSE: AHR) was initiated with a Buy at Compass Point, with a $70 target price. Insmed (NASDAQ: INSM) was initiated with an Outperform rating at BMO Capital, with a $192 target price. 
Ligand Pharmaceutical (NASDAQ: LGND) was resumed with a Buy rating at Citigroup, which has a $387 target price for the stock. Microsoft Corporation (NASDAQ: MSFT) was assumed in coverage with an Overweight rating at Morgan Stanley, which has a $600 target price for the legacy software giant. Stewart Information Services (NYSE: STC) was initiated with a Buy rating at Benchmark, which has an $87 target price. Act now: the analyst who called NVIDIA in 2010 just named his top 10 AI stocks — and Microsoft didn't make the cut. Grab the names FREE today.

Contact [email protected] for any questions or corrections.

Posted by Defense World Staff on Jul 19th, 2026

Bank of New York Mellon Corp lessened its stake in shares of Insmed, Inc. (NASDAQ:INSM – Free Report) by 9.2% during the first quarter, according to the company in its most recent disclosure with the Securities and Exchange Commission (SEC). The institutional investor owned 1,262,749 shares of the biopharmaceutical company’s stock after selling 127,293 shares during the quarter. Bank of New York Mellon Corp owned 0.59% of Insmed worth $206,485,000 at the end of the most recent quarter.

Several other institutional investors and hedge funds also recently modified their holdings of the stock. CIBC Private Wealth Group LLC grew its stake in shares of Insmed by 42.1% in the third quarter. CIBC Private Wealth Group LLC now owns 179 shares of the biopharmaceutical company’s stock valued at $26,000 after buying an additional 53 shares in the last quarter. CoreCap Advisors LLC purchased a new stake in shares of Insmed during the fourth quarter valued at approximately $27,000. GraniteShares Advisors LLC purchased a new stake in shares of Insmed during the fourth quarter valued at approximately $30,000. Reflection Asset Management acquired a new position in shares of Insmed during the fourth quarter worth $30,000. Finally, Raiffeisen Bank International AG acquired a new position in shares of Insmed during the fourth quarter worth $32,000.

Insider Activity at Insmed In related news, insider Michael Alexander Smith sold 6,149 shares of Insmed stock in a transaction dated Friday, May 22nd. The stock was sold at an average price of $108.47, for a total value of $666,982.03. Following the completion of the transaction, the insider directly owned 41,613 shares in the company, valued at approximately $4,513,762.11. This trade represents a 12.87% decrease in their ownership of the stock. The transaction was disclosed in a document filed with the Securities & Exchange Commission, which is accessible through this link. The transaction was executed under a pre-arranged Rule 10b5-1 trading plan. Also, CEO William Lewis sold 21,398 shares of the business’s stock in a transaction dated Thursday, June 25th. The shares were sold at an average price of $103.32, for a total value of $2,210,841.36. Following the completion of the sale, the chief executive officer directly owned 258,917 shares of the company’s stock, valued at approximately $26,751,304.44. This represents a 7.63% decrease in their ownership of the stock. The SEC filing for this sale provides additional information. The transaction was executed under a pre-arranged Rule 10b5-1 trading plan. Over the last three months, insiders sold 54,590 shares of company stock worth $5,793,738. 2.10% of the stock is currently owned by company insiders.

Insmed Trading Up 0.8% INSM opened at $108.32 on Friday. Insmed, Inc. has a 12-month low of $90.39 and a 12-month high of $212.75. The company has a debt-to-equity ratio of 0.80, a current ratio of 4.47 and a quick ratio of 4.10. The stock has a market capitalization of $23.48 billion, a PE ratio of -18.84 and a beta of 0.78. The firm’s fifty day moving average price is $105.72 and its 200 day moving average price is $135.91.

Insmed (NASDAQ:INSM – Get Free Report) last announced its quarterly earnings data on Thursday, May 7th. The biopharmaceutical company reported ($0.76) earnings per share for the quarter, topping the consensus estimate of ($0.90) by $0.14. The company had revenue of $305.96 million during the quarter, compared to analyst estimates of $300.81 million. Insmed had a negative net margin of 144.44% and a negative return on equity of 130.11%. The firm’s revenue for the quarter was up 229.7% compared to the same quarter last year. During the same period last year, the business earned ($1.42) EPS. As a group, research analysts expect that Insmed, Inc. will post -2.43 EPS for the current fiscal year.

Analyst Upgrades and Downgrades A number of research firms recently weighed in on INSM. Wells Fargo & Company raised their price target on shares of Insmed from $160.00 to $161.00 and gave the company an “overweight” rating in a report on Wednesday. Guggenheim reiterated a “buy” rating and issued a $207.00 price objective on shares of Insmed in a report on Friday, July 10th. Roth Capital reissued a “buy” rating on shares of Insmed in a research report on Monday, June 8th. JPMorgan Chase & Co. lowered their target price on Insmed from $180.00 to $179.00 and set an “overweight” rating for the company in a research note on Monday, June 8th. Finally, Weiss Ratings reaffirmed a “sell (d-)” rating on shares of Insmed in a research report on Tuesday, April 21st. One analyst has rated the stock with a Strong Buy rating, twenty-three have issued a Buy rating and one has assigned a Sell rating to the stock. According to data from MarketBeat.com, the company has a consensus rating of “Moderate Buy” and an average price target of $211.05.

Read Our Latest Stock Report on Insmed

Insmed Company Profile (Free Report)

Insmed Incorporated is a biopharmaceutical company focused on developing and commercializing therapies for patients with rare and serious diseases, with a particular emphasis on difficult-to-treat pulmonary infections. Headquartered in Bridgewater, New Jersey, the company concentrates its research and development efforts on targeted drug delivery technologies and novel formulations intended to improve clinical outcomes for patients who have limited treatment options.

The company’s principal marketed product is ARIKAYCE (amikacin liposome inhalation suspension), an inhaled liposomal formulation of the antibiotic amikacin that is approved by the U.S.

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PAH is a rare, progressive disease where the tiny arteries in the lungs narrow, increasing blood pressure and forcing the heart to work harder.

Sustained Efficacy Seen Across Key Clinical MeasuresThe company said the data showed sustained improvements across multiple efficacy measures and similar benefits among patients who switched from placebo to TPIP, reinforcing its confidence as the Phase 3 PALM-PAH trial moves forward.

The OLE study was designed to assess the long-term safety, tolerability, and effectiveness of TPIP over 24 months in patients who completed earlier TPIP PAH studies.

The non-placebo-controlled trial enrolled patients who either continued TPIP treatment or crossed over from placebo.

Patients Continuing And Switching To TPIP Posted Similar ResultsAt the 12-month mark, patients who remained on TPIP (n=60) and those who switched from placebo (n=31) produced comparable outcomes across all major efficacy endpoints.

Patients continuing TPIP improved their six-minute walk distance by an average of 55.7 meters from baseline, while those crossing over from placebo improved by 54.1 meters.

Both groups also recorded roughly a 60% reduction in N-terminal fragment pro-B-type natriuretic peptide (NT-proBNP, a biomarker for heart failure) concentrations.

In addition, 78.3% of patients in the TPIP continued group and 80.6% in the placebo crossover group achieved World Health Organization Functional Class I or II by Month 12.

More than one-quarter of patients across both groups reached Functional Class I.

The mean REVEAL Lite 2.0 score improved by 2.0 points in the TPIP continued group and 1.4 points among patients who switched from placebo.

Approximately 65% of patients achieved Refined Low Risk status, which is associated with an estimated mortality risk of less than 5% over three years and about a 7% risk of clinical worsening within one year.

Safety Profile Supports Ongoing Phase 3 DevelopmentInsmed said once-daily TPIP remained generally well tolerated at doses up to 1,280 micrograms through Month 12, with no newly identified safety signals.

The company said the findings support continued development of TPIP and the recently initiated Phase 3 PALM-PAH trial.

INSM Stock Price Activity: Insmed shares were down 3.67% at $105.77 at the time of publication on Thursday, according to Benzinga Pro data.

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–12-Month Data Demonstrated Sustained Improvement with TPIP Across All Secondary Efficacy Measures Including Reduction in Mortality Risk Status by REVEAL Lite 2.0–

–Placebo Crossed Group Demonstrated Treatment Response on TPIP, Achieving Similar Outcomes to the TPIP Continued Group by Month 12–

–TPIP Was Safe and Well-tolerated with No Newly Identified Safety Signals through Month 12; Doses Up to 1,280 µg Once Daily Were Permitted in the OLE Study–

–These OLE Data, Combined with Once-Daily Inhaled Administration, Reinforce TPIP's Potential to Become the Prostanoid of Choice for Patients with PAH–

–Insmed to Host Investor Call Thursday, July 16, 2026, at 8:00 a.m. ET–

, /PRNewswire/ -- Insmed Incorporated (Nasdaq: INSM), a people-first global biopharmaceutical company striving to deliver first- and best-in-class therapies to transform the lives of patients facing serious diseases, today announced positive 12-Month data from the ongoing open-label extension (OLE) study evaluating treprostinil palmitil inhalation powder (TPIP), administered once daily in patients with pulmonary arterial hypertension (PAH, World Health Organization Group 1). The OLE study is a non-placebo-controlled trial and was designed to evaluate the long-term safety, tolerability, and effectiveness of TPIP over 24 months in patients who completed the lead-in TPIP PAH studies.

"These data from our ongoing OLE study with TPIP represent an important milestone in our efforts to fully harness the potential of treprostinil and provide meaningful benefit to patients with pulmonary arterial hypertension," said Gene Sullivan, M.D., Chief Product Strategy Officer of Insmed. "In this analysis, TPIP demonstrated sustained improvement across all efficacy endpoints and was well tolerated with no newly identified safety signals, and notably, patients who switched from placebo to TPIP in the OLE study achieved similar clinical benefit. These data, coupled with the statistically significant and clinically meaningful results from our Phase 2b randomized study, demonstrate TPIP's potential to become the prostanoid of choice for PAH patients, and we remain excited to be advancing our Phase 3 PALM-PAH study."

12-Month Results from the Ongoing OLE Study with TPIP in Patients with PAH
Results for secondary efficacy endpoints demonstrated sustained improvement with TPIP in six-minute walk distance (6MWD), N-terminal fragment pro-B-type natriuretic peptide (NT-proBNP) concentration, and World Health Organization (WHO) Functional Class, as well as a clinically meaningful improvement in REVEAL Lite 2.0 score at Month 12. Patients in the Placebo Crossed group (N=31) showed similar outcomes to patients in the TPIP Continued group (N=60) across all efficacy measures at Month 12.

The results at Month 12 were as follows:

Mean improvement from baseline for 6MWD was +55.7 meters for the TPIP Continued group and +54.1 meters for the Placebo Crossed group. NT-proBNP concentration was reduced by approximately 60% in both groups with geometric mean ratios [GMR] to baseline of 0.40 and 0.41 in TPIP Continued and Placebo Crossed, respectively. WHO Functional Class I or II was achieved in 78.3% of TPIP Continued group and 80.6% of Placebo Crossed group patients, and more than 25% of patients across both groups achieved WHO Functional Class I.  Mean REVEAL Lite 2.0 score improved 2.0-points from baseline for the TPIP Continued group and 1.4-points from baseline for the Placebo Crossed group. Approximately 65% of all patients achieved Refined Low Risk status, which is associated with a less than 5% estimated risk of mortality at three years and an approximately 7% risk of clinical worsening at one year. "Pulmonary arterial hypertension is one of the most devastating diseases we face as clinicians, and these results from the ongoing TPIP OLE study give us genuine reason for optimism," said Dr. Raymond Benza, M.D., F.A.C.C., FAHA, FACP, Phase 2b PAH study Steering Committee Member, George M. and Linda H. Kaufman Academic Chair of Cardiology, Sentara Health. "The REVEAL Lite 2.0 risk score provides a powerful, non-invasive way to track disease trajectory. Previous REVEAL Lite 2.0 validation showed that a 1-point score improvement reduces risk of mortality by 23% and reduces the risk of clinical worsening by 21%. Here we saw that patients on TPIP averaged a greater than 1-point improvement from baseline, which is really meaningful for patients. Sustained improvements of this magnitude, alongside gains in exercise capacity and Functional Class, provide a strong clinical rationale to advance this therapy into Phase 3 development." 

Results for the primary endpoint of safety & tolerability showed that once-daily TPIP therapy was generally well tolerated with no newly identified safety signals at doses up to 1,280 µg through Month 12. Of the 91 patients in the study, treatment-emergent adverse events (TEAEs) occurred in 89.0% of patients; serious TEAEs were observed in 18.7% of patients; and severe TEAEs were observed in 16.5% of patients in the study. TEAEs leading to study discontinuation were experienced by 7.7% of patients. There were four deaths, none of which were considered related to TPIP treatment. The most common TEAEs through Month 12 occurring in 5.0% or more of all patients were headache (28.6%), cough (15.4%), nasopharyngitis (14.3%), diarrhea (11.0%), upper respiratory tract infection (9.9%), bronchitis (7.7%), dizziness (6.6%), epistaxis (6.6%), nausea (6.6%), anemia (5.5%), influenza (5.5%), and pneumonia (5.5%).

The 12-Month OLE findings support the continued clinical development of TPIP and the recent initiation of PALM-PAH, a Phase 3, randomized, double-blind, placebo-controlled trial evaluating once-daily TPIP in patients with PAH over 24 weeks. The primary endpoint of PALM-PAH is change in 6MWD, with additional assessments of safety, tolerability, and overall efficacy. Insmed plans to publish the 12-Month results from this OLE study in the future. Topline results from the Phase 2b study of TPIP in patients with PAH were previously reported in June 2025.

Conference Call Information 

Insmed management will host a conference call for investors beginning at 8:00 a.m. ET on Thursday, July 16, 2026, to discuss the TPIP OLE study results. Shareholders and other interested parties may participate in the conference call by dialing (800) 715-9871 (U.S.) or +1 (646) 307-1963 (International) and referencing access code 2033335. The call will also be webcast live on the Company's website at www.insmed.com. 

A replay of the conference call will be accessible approximately one hour after its completion through July 23, 2026, by dialing (800) 770-2030 (U.S. and Canada) or +1 (609) 800-9909 (International) and referencing access code 2033335. A webcast of the call will also be archived for 90 days under the Investor Relations section of the Company's website at www.insmed.com.

About TPIP

Treprostinil palmitil inhalation powder (TPIP) is a dry powder formulation of treprostinil palmitil, a treprostinil prodrug consisting of treprostinil linked by an ester bond to a 16-carbon chain. Developed entirely in Insmed's laboratories, TPIP is a potentially highly differentiated prostanoid being evaluated as a once-daily therapy for the treatment of patients with PAH, pulmonary hypertension associated with interstitial lung disease (PH-ILD), progressive pulmonary fibrosis (PPF), and idiopathic pulmonary fibrosis (IPF). TPIP is administered in a capsule-based inhalation device. TPIP is an investigational drug product that has not been approved for any indication in any jurisdiction. 

About the TPIP Open-Label Extension Study

The 24-month open-label extension (OLE) study of treprostinil palmitil inhalation powder (TPIP) in patients with pulmonary arterial hypertension (PAH) was designed to evaluate the long-term safety, tolerability, and effectiveness of TPIP administered once daily in patients who completed the lead-in TPIP PAH studies. The OLE is being conducted at 45 sites globally and enrolled 91 eligible patients. The study included a 3-week blinded titration period followed by open-label treatment. Patients who received TPIP in the lead-in studies (TPIP Continued) received their achieved dose of TPIP; patients who received placebo in the lead-in studies (Placebo Crossed), or had delayed rollover, underwent titration starting at 80 µg once daily up to their target dose (i.e., 640 µg or highest tolerated dose) over three weeks. Further escalation up to 1,280 µg was permitted after the initial titration period at investigator discretion to optimize clinical benefit. Outcomes were evaluated against the Phase 2b lead-in study in PAH (NCT05147805) pre-randomization baseline values for relevant measurements. 

The primary endpoint is evaluating long-term safety and tolerability, including treatment-emergent adverse events (TEAEs) and TEAEs by severity. Secondary endpoints include change from lead-in study pre-randomization baseline in six-minute walk distance (6MWD), N-terminal fragment pro-B-type natriuretic peptide (NT-proBNP) concentration, World Health Organization (WHO) Functional Class, REVEAL Lite 2.0 score, and additional exploratory measures over 24 months of treatment. 

About Pulmonary Arterial Hypertension

Pulmonary arterial hypertension (PAH) is a serious, progressive, rare disease in which the blood vessels in the lungs narrow or become obstructed, leading to high blood pressure in the pulmonary arteries. The most common symptoms include shortness of breath, chest pain, dizziness or fainting, fatigue, and weakness. It is estimated that approximately 35,000 patients in the U.S., 40,000 patients in the EU5 (France, Germany, Italy, Spain, and the UK), and 15,000 patients in Japan have been diagnosed with the disease. Untreated PAH can be debilitating and often fatal.

About Insmed

Insmed Incorporated is a people-first global biopharmaceutical company striving to deliver first- and best-in-class therapies to transform the lives of patients facing serious diseases. The Company is advancing a diverse portfolio of approved and mid- to late-stage investigational medicines—including two approved therapies to treat chronic, debilitating lung diseases—as well as cutting-edge drug discovery focused on serving patient communities where the need is greatest. Insmed's commercial portfolio and clinical pipeline are organized around three therapeutic areas: Respiratory, Immunology & Inflammation, and Neuro & Other Rare. The Company's research engine is advancing a wide range of technologies and modalities, including gene therapy, AI-driven protein engineering, RNA end-joining, and synthetic rescue, in the pursuit of future pipeline candidates.

Headquartered in Bridgewater, New Jersey, Insmed has offices and research locations throughout the United States, Europe, and Japan. Insmed is proud to be recognized as one of the best employers in the biopharmaceutical industry, including spending five consecutive years as the No. 1 Science Top Employer. Visit www.insmed.com to learn more or follow us on LinkedIn, Instagram, YouTube, and X.

Forward-looking Statements 

This press release contains forward-looking statements that involve substantial risks and uncertainties. "Forward-looking statements," as that term is defined in the Private Securities Litigation Reform Act of 1995, are statements that are not historical facts and involve a number of risks and uncertainties. Words herein such as "may," "will," "should," "could," "would," "expects," "plans," "anticipates," "believes," "estimates," "projects," "predicts," "intends," "potential," "continues," and similar expressions (as well as other words or expressions referencing future events, conditions or circumstances) may identify forward-looking statements.

The forward-looking statements in this press release are based upon the Company's current expectations and beliefs, and involve known and unknown risks, uncertainties and other factors, which may cause the Company's actual results, performance and achievements and the timing of certain events to differ materially from the results, performance, achievements or timings discussed, projected, anticipated or indicated in any forward-looking statements. Such risks, uncertainties and other factors include, among others, the following: the risk that the full data set from the OLE study of TPIP in PAH (the "Study") or data generated in further clinical trials of TPIP will not be consistent with the interim results of the Study; the risk that data from the Study, which is conducted in a single-arm, open-label design without a concurrent placebo control group, may not be predictive of, or may differ materially from, results obtained in the Phase 3 PALM-PAH randomized, double-blind, placebo-controlled trial; the risk that the Study's efficacy endpoints, which are secondary and exploratory in nature, may overestimate or otherwise not accurately reflect the true treatment effect of TPIP; failure to successfully conduct future clinical trials for TPIP, such as the Company's planned Phase 3 program for TPIP, including due to the Company's potential inability to enroll or retain sufficient patients to conduct and complete the trials or generate data necessary for regulatory approval, among other things; development of unexpected safety or efficacy concerns related to TPIP; failure of third parties on which the Company is dependent to manufacture sufficient quantities of TPIP for clinical needs, to conduct the Company's clinical trials, or to comply with the Company's agreements or laws and regulations that impact the Company's business or agreements with the Company; failure to obtain regulatory approval for TPIP; inaccuracies in the Company's estimates of the size of the potential markets for TPIP or in data the Company has used to identify physicians; expected rates of patient uptake, duration of expected treatment, or expected patient adherence or discontinuation rates, if TPIP is approved; inability of the Company or the Company's third-party manufacturers to comply with regulatory requirements related to TPIP; the Company's inability to obtain adequate reimbursement from government or third-party payors for TPIP or acceptable prices for TPIP, if approved; restrictions or other obligations imposed on the Company by agreements related to TPIP and failure to comply with the Company's obligations under such agreements; risks that the Company's clinical studies will be delayed or that serious side effects will be identified during drug development; the strength and enforceability of the Company's intellectual property rights or the rights of third parties; and the cost and potential reputational damage resulting from litigation to which the Company may become a party, including product liability claims.

The Company may not actually achieve the results, plans, intentions or expectations indicated by the Company's forward-looking statements because, by their nature, forward-looking statements involve risks and uncertainties because they relate to events and depend on circumstances that may or may not occur in the future. For additional information about the risks and uncertainties that may affect the Company's business, please see the factors discussed in Item 1A, "Risk Factors," in the Company's Annual Report on Form 10-K for the year ended December 31, 2025 and any subsequent Company filings with the Securities and Exchange Commission (SEC).

The Company cautions readers not to place undue reliance on any such forward-looking statements, which speak only as of the date of this press release. The Company disclaims any obligation, except as specifically required by law and the rules of the SEC, to publicly update or revise any such statements to reflect any change in expectations or in events, conditions or circumstances on which any such statements may be based, or that may affect the likelihood that actual results will differ from those set forth in the forward-looking statements.

Contact:

Investors:
Bryan Dunn
Vice President, Investor Relations
(646) 812-4030
[email protected]

Media:
Claire Mulhearn
Vice President, Corporate Communications
(862) 842-6819
[email protected]

SOURCE Insmed Incorporated

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Posted by Defense World Staff on Apr 20th, 2026

Mirae Asset Global Investments Co. Ltd. increased its holdings in shares of Insmed, Inc. (NASDAQ:INSM – Free Report) by 764.3% during the 4th quarter, according to its most recent Form 13F filing with the Securities and Exchange Commission (SEC). The institutional investor owned 78,492 shares of the biopharmaceutical company’s stock after acquiring an additional 69,410 shares during the period. Mirae Asset Global Investments Co. Ltd.’s holdings in Insmed were worth $13,661,000 at the end of the most recent reporting period.

Several other hedge funds have also bought and sold shares of INSM. EverSource Wealth Advisors LLC boosted its stake in Insmed by 65.6% during the second quarter. EverSource Wealth Advisors LLC now owns 664 shares of the biopharmaceutical company’s stock worth $67,000 after acquiring an additional 263 shares in the last quarter. First Trust Advisors LP lifted its stake in shares of Insmed by 80.8% in the second quarter. First Trust Advisors LP now owns 47,392 shares of the biopharmaceutical company’s stock worth $4,770,000 after buying an additional 21,176 shares in the last quarter. Baird Financial Group Inc. bought a new position in shares of Insmed in the second quarter worth approximately $2,589,000. Amundi lifted its stake in shares of Insmed by 21,194.4% in the second quarter. Amundi now owns 11,499 shares of the biopharmaceutical company’s stock worth $1,130,000 after buying an additional 11,445 shares in the last quarter. Finally, Natixis bought a new position in shares of Insmed in the second quarter worth approximately $1,072,000.

Analyst Ratings Changes INSM has been the topic of several analyst reports. Roth Mkm reiterated a “buy” rating and issued a $212.00 target price on shares of Insmed in a research note on Friday. Wells Fargo & Company dropped their target price on shares of Insmed from $208.00 to $175.00 and set an “overweight” rating on the stock in a research note on Monday, March 23rd. Raymond James Financial initiated coverage on shares of Insmed in a research note on Friday, April 10th. They issued an “outperform” rating and a $200.00 target price on the stock. Guggenheim reiterated a “buy” rating and issued a $230.00 target price on shares of Insmed in a research note on Thursday. Finally, Leerink Partners upped their target price on shares of Insmed from $210.00 to $215.00 and gave the stock an “outperform” rating in a research note on Tuesday, March 24th. Two equities research analysts have rated the stock with a Strong Buy rating, twenty-two have issued a Buy rating and one has assigned a Sell rating to the company’s stock. Based on data from MarketBeat, the company presently has an average rating of “Buy” and an average price target of $213.23.

Get Our Latest Research Report on Insmed

Insider Activity at Insmed In related news, CEO William Lewis sold 13,396 shares of the stock in a transaction that occurred on Monday, February 9th. The shares were sold at an average price of $147.79, for a total transaction of $1,979,794.84. Following the transaction, the chief executive officer owned 301,185 shares in the company, valued at $44,512,131.15. This represents a 4.26% decrease in their ownership of the stock. The sale was disclosed in a document filed with the Securities & Exchange Commission, which is available at the SEC website. Also, COO Roger Adsett sold 88,060 shares of the stock in a transaction that occurred on Wednesday, April 1st. The shares were sold at an average price of $164.63, for a total transaction of $14,497,317.80. Following the transaction, the chief operating officer owned 106,810 shares in the company, valued at approximately $17,584,130.30. This trade represents a 45.19% decrease in their position. The disclosure for this sale is available in the SEC filing. Insiders have sold a total of 190,476 shares of company stock worth $29,953,112 over the last quarter. Company insiders own 2.10% of the company’s stock.

Insmed Price Performance Shares of Insmed stock opened at $144.48 on Monday. The company has a market cap of $31.19 billion, a price-to-earnings ratio of -22.54 and a beta of 1.10. The company’s 50 day moving average is $149.95 and its 200 day moving average is $167.61. Insmed, Inc. has a twelve month low of $63.81 and a twelve month high of $212.75. The company has a quick ratio of 3.54, a current ratio of 3.83 and a debt-to-equity ratio of 0.76.

Insmed (NASDAQ:INSM – Get Free Report) last issued its quarterly earnings data on Thursday, February 19th. The biopharmaceutical company reported ($1.54) earnings per share for the quarter, missing analysts’ consensus estimates of ($1.07) by ($0.47). The company had revenue of $263.84 million for the quarter, compared to the consensus estimate of $263.97 million. Insmed had a negative net margin of 210.54% and a negative return on equity of 168.36%. The firm’s revenue for the quarter was up 152.6% on a year-over-year basis. During the same quarter last year, the company earned ($1.32) EPS. Research analysts anticipate that Insmed, Inc. will post -4.56 EPS for the current year.

Insmed Company Profile (Free Report)

Insmed Incorporated is a biopharmaceutical company focused on developing and commercializing therapies for patients with rare and serious diseases, with a particular emphasis on difficult-to-treat pulmonary infections. Headquartered in Bridgewater, New Jersey, the company concentrates its research and development efforts on targeted drug delivery technologies and novel formulations intended to improve clinical outcomes for patients who have limited treatment options.

The company’s principal marketed product is ARIKAYCE (amikacin liposome inhalation suspension), an inhaled liposomal formulation of the antibiotic amikacin that is approved by the U.S.

Featured Articles Five stocks we like better than Insmed Want to see what other hedge funds are holding INSM? Visit HoldingsChannel.com to get the latest 13F filings and insider trades for Insmed, Inc. (NASDAQ:INSM – Free Report).

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Posted by Defense World Staff on Apr 21st, 2026

GraniteShares Advisors LLC purchased a new position in shares of Insmed, Inc. (NASDAQ:INSM – Free Report) in the fourth quarter, according to its most recent filing with the Securities and Exchange Commission (SEC). The fund purchased 3,905 shares of the biopharmaceutical company’s stock, valued at approximately $680,000.

A number of other large investors also recently modified their holdings of the business. EULAV Asset Management bought a new stake in shares of Insmed in the 3rd quarter worth approximately $12,961,000. Artisan Partners Limited Partnership lifted its position in shares of Insmed by 49.0% in the 3rd quarter. Artisan Partners Limited Partnership now owns 4,937,683 shares of the biopharmaceutical company’s stock worth $711,076,000 after acquiring an additional 1,623,342 shares during the period. Atika Capital Management LLC bought a new stake in shares of Insmed in the 3rd quarter worth approximately $13,681,000. Nisa Investment Advisors LLC lifted its position in shares of Insmed by 374.6% in the 3rd quarter. Nisa Investment Advisors LLC now owns 10,466 shares of the biopharmaceutical company’s stock worth $1,507,000 after acquiring an additional 8,261 shares during the period. Finally, Nordea Investment Management AB bought a new stake in shares of Insmed in the 4th quarter worth approximately $3,492,000.

Insmed Trading Down 1.1% INSM opened at $142.82 on Tuesday. The company has a current ratio of 3.83, a quick ratio of 3.54 and a debt-to-equity ratio of 0.76. The stock has a market capitalization of $30.83 billion, a PE ratio of -22.28 and a beta of 1.10. Insmed, Inc. has a 1-year low of $63.81 and a 1-year high of $212.75. The firm has a 50-day moving average price of $149.82 and a two-hundred day moving average price of $167.54.

Insmed (NASDAQ:INSM – Get Free Report) last posted its quarterly earnings data on Thursday, February 19th. The biopharmaceutical company reported ($1.54) earnings per share for the quarter, missing the consensus estimate of ($1.07) by ($0.47). The company had revenue of $263.84 million during the quarter, compared to analyst estimates of $263.97 million. Insmed had a negative net margin of 210.54% and a negative return on equity of 168.36%. The company’s revenue was up 152.6% compared to the same quarter last year. During the same quarter in the previous year, the business posted ($1.32) EPS. As a group, equities analysts anticipate that Insmed, Inc. will post -2.51 earnings per share for the current fiscal year.

Analyst Ratings Changes A number of brokerages have commented on INSM. Weiss Ratings reiterated a “sell (d-)” rating on shares of Insmed in a research report on Thursday, January 22nd. Raymond James Financial began coverage on Insmed in a research report on Friday, April 10th. They issued an “outperform” rating and a $200.00 price objective for the company. Roth Mkm reiterated a “buy” rating and issued a $212.00 price objective on shares of Insmed in a research report on Friday. Jefferies Financial Group initiated coverage on Insmed in a research report on Monday, March 16th. They issued a “buy” rating and a $228.00 price objective for the company. Finally, Stifel Nicolaus lifted their price objective on Insmed from $205.00 to $208.00 and gave the company a “buy” rating in a report on Tuesday, March 24th. Two research analysts have rated the stock with a Strong Buy rating, twenty-two have issued a Buy rating and one has assigned a Sell rating to the company’s stock. According to data from MarketBeat, the stock presently has a consensus rating of “Buy” and a consensus target price of $213.23.

View Our Latest Research Report on Insmed

Insiders Place Their Bets In other Insmed news, CEO William Lewis sold 10,699 shares of the business’s stock in a transaction dated Thursday, April 16th. The stock was sold at an average price of $143.97, for a total transaction of $1,540,335.03. Following the completion of the sale, the chief executive officer directly owned 301,185 shares of the company’s stock, valued at approximately $43,361,604.45. The trade was a 3.43% decrease in their position. The sale was disclosed in a document filed with the SEC, which can be accessed through the SEC website. The transaction was executed under a pre-arranged Rule 10b5-1 trading plan. Also, COO Roger Adsett sold 88,060 shares of the business’s stock in a transaction dated Wednesday, April 1st. The stock was sold at an average price of $164.63, for a total value of $14,497,317.80. Following the sale, the chief operating officer directly owned 106,810 shares of the company’s stock, valued at $17,584,130.30. This represents a 45.19% decrease in their ownership of the stock. The SEC filing for this sale provides additional information. In the last three months, insiders sold 179,777 shares of company stock valued at $28,252,720. 2.10% of the stock is currently owned by insiders.

About Insmed (Free Report)

Insmed Incorporated is a biopharmaceutical company focused on developing and commercializing therapies for patients with rare and serious diseases, with a particular emphasis on difficult-to-treat pulmonary infections. Headquartered in Bridgewater, New Jersey, the company concentrates its research and development efforts on targeted drug delivery technologies and novel formulations intended to improve clinical outcomes for patients who have limited treatment options.

The company’s principal marketed product is ARIKAYCE (amikacin liposome inhalation suspension), an inhaled liposomal formulation of the antibiotic amikacin that is approved by the U.S.

Read More Five stocks we like better than Insmed Want to see what other hedge funds are holding INSM? Visit HoldingsChannel.com to get the latest 13F filings and insider trades for Insmed, Inc. (NASDAQ:INSM – Free Report).

Receive News & Ratings for Insmed Daily - Enter your email address below to receive a concise daily summary of the latest news and analysts' ratings for Insmed and related companies with MarketBeat.com's FREE daily email newsletter.

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, /PRNewswire/ -- Insmed Incorporated (Nasdaq: INSM), a people-first global biopharmaceutical company striving to deliver first- and best-in-class therapies to transform the lives of patients facing serious diseases, today announced that management will present at the following investor conferences:

BofA Securities 2026 Healthcare Conference in Las Vegas on Tuesday, May 12, 2026, at 1:40 p.m. PT. 2026 RBC Capital Markets Global Healthcare Conference in New York City on Wednesday, May 20, 2026, at 10:30 a.m. ET. These events will be webcast live and can be accessed by visiting the investor relations section of the Company's website at www.insmed.com. Webcasts will be archived for a period of 30 days following the conclusion of the live events.

About Insmed

Insmed Incorporated is a people-first global biopharmaceutical company striving to deliver first- and best-in-class therapies to transform the lives of patients facing serious diseases. The Company is advancing a diverse portfolio of approved and mid- to late-stage investigational medicines as well as cutting-edge drug discovery focused on serving patient communities where the need is greatest. Insmed's most advanced programs are in pulmonary and inflammatory conditions, including two approved therapies to treat chronic, debilitating lung diseases. The Company's early-stage programs encompass a wide range of technologies and modalities, including gene therapy, AI-driven protein engineering, protein manufacturing, RNA end-joining, and synthetic rescue.

Headquartered in Bridgewater, New Jersey, Insmed has offices and research locations throughout the United States, Europe, and Japan. Insmed is proud to be recognized as one of the best employers in the biopharmaceutical industry, including spending five consecutive years as the No. 1 Science Top Employer. Visit www.insmed.com to learn more or follow us on LinkedIn, Instagram, YouTube, and X. 

Contact:

Investors:
Bryan Dunn
Vice President, Investor Relations
(646) 812-4030
[email protected]

Media:
Claire Mulhearn
Vice President, Corporate Communications
(862) 842-6819
[email protected]

SOURCE Insmed Incorporated

—New Data in Non-Cystic Fibrosis Bronchiectasis Further Define Impact of BRINSUPRI® on Respiratory Symptoms—

—Findings from a Pharmacokinetic Study Continue to Support Further Evaluation of Treprostinil Palmitil Inhalation Powder Phase 3 Development Program—

—Additionally, Insmed Provides Independent Research Grant to the American Thoracic Society for a Landmark Quality Initiative to Improve Diagnosis of Bronchiectasis across the U.S.—

, /PRNewswire/ -- Insmed Incorporated (Nasdaq: INSM), a people-first global biopharmaceutical company striving to deliver first- and best-in-class therapies to transform the lives of patients facing serious diseases, today announced that it will present six abstracts from across its respiratory portfolio and pipeline at the American Thoracic Society International Conference 2026 (ATS 2026), taking place May 17–20 in Orlando, Florida.

Notably, data will be presented from the Phase 3b ENCORE study evaluating ARIKAYCE® (amikacin liposome inhalation suspension) with multidrug therapy (azithromycin 250 mg + ethambutol 15 mg/kg) once-daily versus placebo with multidrug therapy once-daily in diagnosed adult patients with a new occurrence of Mycobacterium avium complex (MAC) lung infection who had not received antibiotics. Additional presentations include a post-hoc analysis from the Phase 3 ASPEN trial of BRINSUPRI® (brensocatib), real-world experience data in patients with non-cystic fibrosis bronchiectasis (NCFB), a pharmacokinetic analysis of investigational treprostinil palmitil inhalation powder (TPIP), and data highlighting disease burden in pulmonary hypertension associated with interstitial lung disease (PH-ILD).

"At Insmed, our work in respiratory disease is guided by the experiences of people living with serious and rare pulmonary conditions, where meaningful treatment advances are still urgently needed," said Martina Flammer, M.D., MBA, Chief Medical Officer of Insmed. "The research we're presenting at ATS 2026 reflects the strength of Insmed's respiratory portfolio and pipeline, and our unwavering commitment to patients. Additionally, we're honored to present the Phase 3b ENCORE study findings as a late breaker, which will highlight compelling evidence of ARIKAYCE's potential use earlier in the treatment journey for patients living with Mycobacterium avium complex lung disease."

Presentations:

Late Breaking Science A71, Sunday, May 17, 11:30 AM – 1:15 PM EDT

Amikacin Liposome Inhalation Suspension for Newly Diagnosed Mycobacterium Avium Complex Lung Disease: Efficacy and Safety From a Phase 3b Study (ENCORE) Poster Session B45, Monday, May 18, 11:30 AM – 1:15 PM EDT

Effect of Brensocatib on Patient-Reported Symptoms in Patients with Non-Cystic Fibrosis Bronchiectasis: A Post Hoc Analysis of QOL-B RSS Individual Items from the ASPEN Phase 3 Trial Poster Session B106, Monday, May 18, 2:15 – 4:15 PM EDT

Population Pharmacokinetics Analysis of Treprostinil Using Data From Phase 1 and 2 Studies of Treprostinil Palmitil Inhalation Powder Poster Session B107, Monday, May 18, 2:15 – 4:15 PM EDT

Patient and Caregiver Survey of Burden of Bronchiectasis in the US and Europe Poster Session C58, Tuesday, May 19, 11:30 AM – 1:15 PM EDT

Long-term Hospitalizations, Comorbidities, and Survival in Patients with Pulmonary Hypertension Associated With Interstitial Lung Disease in Real-World Settings Using the NorstellaLinQ Claims Database Mini Symposium D92, Wednesday, May 20, 11:00 AM – 1:00 PM EDT

Exposure-response Relationships of Brensocatib in Adult and Adolescent Patients With Non-Cystic Fibrosis Bronchiectasis In addition to its scientific presentations, Insmed will also host a Medical Affairs exhibit booth (location #937) at the ATS conference.

American Thoracic Society (ATS) Bronchiectasis Diagnosis Quality Initiative
As announced by the ATS, Insmed is supporting the organization with an independent research grant for a landmark quality improvement initiative aimed at addressing the widespread underdiagnosis of bronchiectasis across the United States. Working with seven academic medical systems, the ATS will independently conduct a large-scale electronic health record study to identify patients misdiagnosed with asthma or COPD, pilot scalable diagnostic interventions, and disseminate findings nationally, with the goal of ensuring patients receive timely, accurate diagnoses and guideline-directed care.

About ARIKAYCE
ARIKAYCE® is approved in the United States as ARIKAYCE (amikacin liposome inhalation suspension), in Europe as ARIKAYCE Liposomal 590 mg Nebuliser Dispersion, and in Japan as ARIKAYCE inhalation 590 mg (amikacin sulfate inhalation drug product). Current international treatment guidelines recommend the use of ARIKAYCE for appropriate patients. ARIKAYCE is a novel, inhaled, once-daily formulation of amikacin, an established antibiotic that was historically administered intravenously and associated with severe toxicity to hearing, balance, and kidney function. Insmed's proprietary PULMOVANCE™ liposomal technology enables the delivery of amikacin directly to the lungs, where liposomal amikacin is taken up by lung macrophages where the infection resides, while limiting systemic exposure. ARIKAYCE is administered once daily using the Lamira® Nebulizer System manufactured by PARI Pharma GmbH (PARI). 

About BRINSUPRI
BRINSUPRI® (brensocatib) is a small molecule, once-daily, oral, reversible inhibitor of dipeptidyl peptidase 1 (DPP1). BRINSUPRI (brensocatib 10 mg and 25 mg tablets) is indicated in the United States for the treatment of non-cystic fibrosis bronchiectasis (NCFB) in adult and pediatric patients 12 years of age or older. In the European Union, BRINSUPRI (brensocatib 25 mg tablets) is approved for the treatment of NCFB in patients 12 years of age and older with two or more exacerbations in the prior 12 months. Brensocatib is designed to inhibit the activation of enzymes (neutrophil serine proteases) in neutrophils that are key drivers of chronic airway inflammation in NCFB.

About TPIP
Treprostinil palmitil inhalation powder (TPIP) is an investigational dry powder formulation of treprostinil palmitil, a treprostinil prodrug consisting of treprostinil linked by an ester bond to a 16-carbon chain. Developed entirely in Insmed's laboratories, TPIP is a potentially highly differentiated prostanoid being evaluated as once-daily therapy for the treatment of patients with pulmonary arterial hypertension (PAH), pulmonary hypertension associated with interstitial lung disease (PH-ILD), and other rare and serious pulmonary disorders. TPIP is administered in a capsule-based inhalation device. TPIP is an investigational drug product that has not been approved for any indication in any jurisdiction. 

IMPORTANT SAFETY INFORMATION AND BOXED WARNING FOR ARIKAYCE IN THE U.S.

WARNING: RISK OF INCREASED RESPIRATORY ADVERSE REACTIONS

ARIKAYCE has been associated with an increased risk of respiratory adverse reactions, including hypersensitivity pneumonitis, hemoptysis, bronchospasm, and exacerbation of underlying pulmonary disease that have led to hospitalizations in some cases.

Hypersensitivity Pneumonitis has been reported with the use of ARIKAYCE in the clinical trials. Hypersensitivity pneumonitis (reported as allergic alveolitis, pneumonitis, interstitial lung disease, allergic reaction to ARIKAYCE) was reported at a higher frequency in patients treated with ARIKAYCE plus background regimen (3.1%) compared to patients treated with a background regimen alone (0%). Most patients with hypersensitivity pneumonitis discontinued treatment with ARIKAYCE and received treatment with corticosteroids. If hypersensitivity pneumonitis occurs, discontinue ARIKAYCE and manage patients as medically appropriate.

Hemoptysis has been reported with the use of ARIKAYCE in the clinical trials. Hemoptysis was reported at a higher frequency in patients treated with ARIKAYCE plus background regimen (17.9%) compared to patients treated with a background regimen alone (12.5%). If hemoptysis occurs, manage patients as medically appropriate.

Bronchospasm has been reported with the use of ARIKAYCE in the clinical trials. Bronchospasm (reported as asthma, bronchial hyperreactivity, bronchospasm, dyspnea, dyspnea exertional, prolonged expiration, throat tightness, wheezing) was reported at a higher frequency in patients treated with ARIKAYCE plus background regimen (28.7%) compared to patients treated with a background regimen alone (10.7%). If bronchospasm occurs during the use of ARIKAYCE, treat patients as medically appropriate. 

Exacerbations of underlying pulmonary disease has been reported with the use of ARIKAYCE in the clinical trials. Exacerbations of underlying pulmonary disease (reported as chronic obstructive pulmonary disease (COPD), infective exacerbation of COPD, infective exacerbation of bronchiectasis) have been reported at a higher frequency in patients treated with ARIKAYCE plus background regimen (14.8%) compared to patients treated with background regimen alone (9.8%). If exacerbations of underlying pulmonary disease occur during the use of ARIKAYCE, treat patients as medically appropriate.

Anaphylaxis and Hypersensitivity Reactions: Serious and potentially life-threatening hypersensitivity reactions, including anaphylaxis, have been reported in patients taking ARIKAYCE. Signs and symptoms include acute onset of skin and mucosal tissue hypersensitivity reactions (hives, itching, flushing, swollen lips/tongue/uvula), respiratory difficulty (shortness of breath, wheezing, stridor, cough), gastrointestinal symptoms (nausea, vomiting, diarrhea, crampy abdominal pain), and cardiovascular signs and symptoms of anaphylaxis (tachycardia, low blood pressure, syncope, incontinence, dizziness). Before therapy with ARIKAYCE is instituted, evaluate for previous hypersensitivity reactions to aminoglycosides. If anaphylaxis or a hypersensitivity reaction occurs, discontinue ARIKAYCE and institute appropriate supportive measures.

Ototoxicity has been reported with the use of ARIKAYCE in the clinical trials. Ototoxicity (including deafness, dizziness, presyncope, tinnitus, and vertigo) were reported with a higher frequency in patients treated with ARIKAYCE plus background regimen (17%) compared to patients treated with background regimen alone (9.8%). This was primarily driven by tinnitus (7.6% in ARIKAYCE plus background regimen vs 0.9% in the background regimen alone arm) and dizziness (6.3% in ARIKAYCE plus background regimen vs 2.7% in the background regimen alone arm). Closely monitor patients with known or suspected auditory or vestibular dysfunction during treatment with ARIKAYCE. If ototoxicity occurs, manage patients as medically appropriate, including potentially discontinuing ARIKAYCE.

Nephrotoxicity was observed during the clinical trials of ARIKAYCE in patients with MAC lung disease but not at a higher frequency than background regimen alone. Nephrotoxicity has been associated with the aminoglycosides. Close monitoring of patients with known or suspected renal dysfunction may be needed when prescribing ARIKAYCE.

Neuromuscular Blockade: Patients with neuromuscular disorders were not enrolled in ARIKAYCE clinical trials. Patients with known or suspected neuromuscular disorders, such as myasthenia gravis, should be closely monitored since aminoglycosides may aggravate muscle weakness by blocking the release of acetylcholine at neuromuscular junctions.

Embryo-Fetal Toxicity: Aminoglycosides can cause fetal harm when administered to a pregnant woman. Aminoglycosides, including ARIKAYCE, may be associated with total, irreversible, bilateral congenital deafness in pediatric patients exposed in utero. Patients who use ARIKAYCE during pregnancy, or become pregnant while taking ARIKAYCE should be apprised of the potential hazard to the fetus.

Contraindications: ARIKAYCE is contraindicated in patients with known hypersensitivity to any aminoglycoside.

Most Common Adverse Reactions: The most common adverse reactions in Trial 1 at an incidence ≥5% for patients using ARIKAYCE plus background regimen compared to patients treated with background regimen alone were dysphonia (47% vs 1%), cough (39% vs 17%), bronchospasm (29% vs 11%), hemoptysis (18% vs 13%), ototoxicity (17% vs 10%), upper airway irritation (17% vs 2%), musculoskeletal pain (17% vs 8%), fatigue and asthenia (16% vs 10%), exacerbation of underlying pulmonary disease (15% vs 10%), diarrhea (13% vs 5%), nausea (12% vs 4%), pneumonia (10% vs 8%), headache (10% vs 5%), pyrexia (7% vs 5%), vomiting (7% vs 4%), rash (6% vs 2%), decreased weight (6% vs 1%), change in sputum (5% vs 1%), and chest discomfort (5% vs 3%).

Drug Interactions: Avoid concomitant use of ARIKAYCE with medications associated with neurotoxicity, nephrotoxicity, and ototoxicity. Some diuretics can enhance aminoglycoside toxicity by altering aminoglycoside concentrations in serum and tissue. Avoid concomitant use of ARIKAYCE with ethacrynic acid, furosemide, urea, or intravenous mannitol.

Overdosage: Adverse reactions specifically associated with overdose of ARIKAYCE have not been identified. Acute toxicity should be treated with immediate withdrawal of ARIKAYCE, and baseline tests of renal function should be undertaken. Hemodialysis may be helpful in removing amikacin from the body. In all cases of suspected overdosage, physicians should contact the Regional Poison Control Center for information about effective treatment.

U.S. INDICATION
LIMITED POPULATION: ARIKAYCE® is indicated in adults, who have limited or no alternative treatment options, for the treatment of Mycobacterium avium complex (MAC) lung disease as part of a combination antibacterial drug regimen in patients who do not achieve negative sputum cultures after a minimum of 6 consecutive months of a multidrug background regimen therapy. As only limited clinical safety and effectiveness data for ARIKAYCE are currently available, reserve ARIKAYCE for use in adults who have limited or no alternative treatment options. This drug is indicated for use in a limited and specific population of patients.

This indication is approved under accelerated approval based on achieving sputum culture conversion (defined as 3 consecutive negative monthly sputum cultures) by Month 6. Clinical benefit has not yet been established. Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trials.

Limitation of Use:
ARIKAYCE has only been studied in patients with refractory MAC lung disease defined as patients who did not achieve negative sputum cultures after a minimum of 6 consecutive months of a multidrug background regimen therapy. The use of ARIKAYCE is not recommended for patients with non-refractory MAC lung disease.

Patients are encouraged to report negative side effects of prescription drugs to the FDA.
Visit www.fda.gov/medwatch, or call 1‑800‑FDA‑1088. You can also call the Company at 1-844-4-INSMED. 

Please see Full Prescribing Information. 

BRINSUPRI® (brensocatib) U.S. INDICATION AND IMPORTANT SAFETY INFORMATION
Indication in the U.S.
BRINSUPRI is indicated for the treatment of non-cystic fibrosis bronchiectasis (NCFB) in adult and pediatric patients 12 years of age and older.

Important Safety Information in the U.S.

WARNINGS AND PRECAUTIONS 

Dermatologic Adverse Reactions
Treatment with BRINSUPRI is associated with an increase in dermatologic adverse reactions, including rash, dry skin, and hyperkeratosis. Monitor patients for development of new rashes or skin conditions and refer patients to a dermatologist for evaluation of new dermatologic findings. 

Gingival and Periodontal Adverse Reactions
Treatment with BRINSUPRI is associated with an increase in gingival and periodontal adverse reactions. Refer patients to dental care services for regular dental checkups while taking BRINSUPRI. Advise patients to perform routine dental hygiene. 

Live Attenuated Vaccines
It is unknown whether administration of live attenuated vaccines during BRINSUPRI treatment will affect the safety or effectiveness of these vaccines. The use of live attenuated vaccines should be avoided in patients receiving BRINSUPRI. 

ADVERSE REACTIONS
The most common adverse reactions ≥2% in the ASPEN trial included upper respiratory tract infection, headache, rash, dry skin, hyperkeratosis, and hypertension. The safety profile for adult patients with NCFB in WILLOW was generally similar to ASPEN, except for a higher incidence of gingival and periodontal adverse reactions. 

Less Common Adverse Reactions
Liver Function Test Elevations
In ASPEN, there was an increase from baseline in average ALT, AST, and alkaline phosphatase levels at all time points from Week 4 through Week 56 in both BRINSUPRI 10 mg and 25 mg arms compared to placebo. The incidence of ALT >3X upper limit of normal (ULN) was 0%, 1.2%, and 0.9%; the incidence of AST >3X ULN was 0.2%, 0.3%, and 0.5%; and the incidence of alkaline phosphatase >1.5X ULN was 2.5%, 4.1%, and 4.0% in patients treated with placebo and BRINSUPRI 10 mg and 25 mg, respectively. 

Skin Cancers
In ASPEN, the incidence of skin cancers among patients treated with BRINSUPRI 10 mg and 25 mg was 0.5% and 1.9%, respectively, compared to 1.1% in placebo-treated patients. 

Alopecia
In ASPEN, the incidence of alopecia among patients treated with BRINSUPRI 10 mg and 25 mg was 1.5% and 1.6% respectively, compared to 0.4% in placebo-treated patients.

USE IN SPECIFIC POPULATIONS 

Pregnancy: There are no clinical data on the use of BRINSUPRI in pregnant women. 

Lactation: There is no information regarding the presence of BRINSUPRI and/or its metabolite(s) in human milk, the effects on the breastfed infant, or the effects on milk production. The developmental and health benefits of breastfeeding should be considered along with the mother's clinical need for BRINSUPRI and any potential adverse effects on the breastfed child from BRINSUPRI or from the underlying maternal condition. 

Pediatric use: The safety and effectiveness of BRINSUPRI for the treatment of NCFB have been established in pediatric patients aged 12 years and older. Common adverse reactions in pediatric patients aged 12 years and older enrolled in ASPEN were consistent with those in adults. The safety and effectiveness of BRINSUPRI have not been established in pediatric patients younger than 12 years of age. 

Please see full US Prescribing Information. 

About Insmed
Insmed Incorporated is a people-first global biopharmaceutical company striving to deliver first- and best-in-class therapies to transform the lives of patients facing serious diseases. The Company is advancing a diverse portfolio of approved and mid- to late-stage investigational medicines as well as cutting-edge drug discovery focused on serving patient communities where the need is greatest. Insmed's most advanced programs are in pulmonary and inflammatory conditions, including two approved therapies to treat chronic, debilitating lung diseases. The Company's early-stage programs encompass a wide range of technologies and modalities, including gene therapy, AI-driven protein engineering, protein manufacturing, RNA end-joining, and synthetic rescue.

Headquartered in Bridgewater, New Jersey, Insmed has offices and research locations throughout the United States, Europe, and Japan. Insmed is proud to be recognized as one of the best employers in the biopharmaceutical industry, including spending five consecutive years as the No. 1 Science Top Employer. Visit www.insmed.com to learn more or follow us on LinkedIn, Instagram, YouTube, and X. 

Forward-looking Statements
This press release contains forward-looking statements that involve substantial risks and uncertainties. "Forward-looking statements," as that term is defined in the Private Securities Litigation Reform Act of 1995, are statements that are not historical facts and involve a number of risks and uncertainties. Words herein such as "may," "will," "should," "could," "would," "expects," "plans," "anticipates," "believes," "estimates," "projects," "predicts," "intends," "potential," "continues," and similar expressions (as well as other words or expressions referencing future events, conditions or circumstances) may identify forward-looking statements.

The forward-looking statements in this press release are based upon the Company's current expectations and beliefs, and involve known and unknown risks, uncertainties and other factors, which may cause the Company's actual results, performance and achievements and the timing of certain events to differ materially from the results, performance, achievements or timings discussed, projected, anticipated or indicated in any forward-looking statements. Such risks, uncertainties and other factors include, among others, the following: risk that interim, topline or preliminary data from our clinical trials that we announce or publish from time to time may change as more patient data become available or may be interpreted differently if additional data are disclosed; failure to successfully conduct future clinical trials for our marketed products or our product candidates and our potential inability to enroll or retain sufficient patients to conduct and complete the trials or generate data necessary for regulatory approval of our product candidates; development of unexpected safety or efficacy concerns related to our marketed products or our product candidates; risks that our clinical studies will be delayed, that serious side effects will be identified during drug development, or that any protocol amendments submitted will be rejected; our inability to obtain full approval of ARIKAYCE from the FDA or our failure to obtain regulatory approval to expand ARIKAYCE's indication to a broader patient population; failure to obtain, or delays in obtaining, regulatory approvals for our product candidates in the U.S., Europe or Japan, for ARIKAYCE outside the U.S., Europe or Japan, including separate regulatory approval for Lamira® in each market and for each usage, or for brensocatib in NCFB in Japan; and failure to successfully commercialize our marketed products and product candidates, if approved by applicable regulatory authorities, or to maintain applicable regulatory approvals for our marketed products and product candidates, if approved.

The Company may not actually achieve the results, plans, intentions, or expectations indicated by the Company's forward-looking statements because, by their nature, forward-looking statements involve risks and uncertainties because they relate to events and depend on circumstances that may or may not occur in the future. For additional information about the risks and uncertainties that may affect the Company's business, please see the factors discussed in Item 1A, "Risk Factors," in the Company's Annual Report on Form 10-K for the year ended December 31, 2025 and any subsequent Company filings with the Securities and Exchange Commission (SEC).

The Company cautions readers not to place undue reliance on any such forward-looking statements, which speak only as of the date of this press release. The Company disclaims any obligation, except as specifically required by law and the rules of the SEC, to publicly update or revise any such statements to reflect any change in expectations or in events, conditions or circumstances on which any such statements may be based, or that may affect the likelihood that actual results will differ from those set forth in the forward-looking statements.

Contact:
Investors:
Bryan Dunn
Vice President, Investor Relations
(646) 812-4030
[email protected]

Media:
Claire Mulhearn
Vice President, Corporate Communications
(862) 842-6819
[email protected]

SOURCE Insmed Incorporated