Insmed má za čtvrtletí vykázat ztrátu 0,33 USD na akcii, což představuje meziroční změnu +81,1 %, při tržbách 501,26 milionu USD, meziročně vyšších o 252,2 %.
The market expects Insmed (INSM - Free Report) to deliver a year-over-year increase in earnings on higher revenues when it reports results for the quarter ended September 2026. This widely-known consensus outlook is important in assessing the company's earnings picture, but a powerful factor that might influence its near-term stock price is how the actual results compare to these estimates.
The stock might move higher if these key numbers top expectations in the upcoming earnings report, which is expected to be released on October 29. On the other hand, if they miss, the stock may move lower.
While management's discussion of business conditions on the earnings call will mostly determine the sustainability of the immediate price change and future earnings expectations, it's worth having a handicapping insight into the odds of a positive EPS surprise.
Zacks Consensus EstimateThis biopharmaceutical developing inhaled treatments for patients battling rare lung diseases is expected to post quarterly loss of $0.33 per share in its upcoming report, which represents a year-over-year change of +81.1%.
Revenues are expected to be $501.26 million, up 252.2% from the year-ago quarter.
Estimate Revisions TrendThe consensus EPS estimate for the quarter has been revised 37.75% higher over the last 30 days to the current level. This is essentially a reflection of how the covering analysts have collectively reassessed their initial estimates over this period.
Investors should keep in mind that an aggregate change may not always reflect the direction of estimate revisions by each of the covering analysts.
Price, Consensus and EPS Surprise
Earnings WhisperEstimate revisions ahead of a company's earnings release offer clues to the business conditions for the period whose results are coming out. Our proprietary surprise prediction model -- the Zacks Earnings ESP (Expected Surprise Prediction) -- has this insight at its core.
The Zacks Earnings ESP compares the Most Accurate Estimate to the Zacks Consensus Estimate for the quarter; the Most Accurate Estimate is a more recent version of the Zacks Consensus EPS estimate. The idea here is that analysts revising their estimates right before an earnings release have the latest information, which could potentially be more accurate than what they and others contributing to the consensus had predicted earlier.
Thus, a positive or negative Earnings ESP reading theoretically indicates the likely deviation of the actual earnings from the consensus estimate. However, the model's predictive power is significant for positive ESP readings only.
A positive Earnings ESP is a strong predictor of an earnings beat, particularly when combined with a Zacks Rank #1 (Strong Buy), 2 (Buy) or 3 (Hold). Our research shows that stocks with this combination produce a positive surprise nearly 70% of the time, and a solid Zacks Rank actually increases the predictive power of Earnings ESP.
Please note that a negative Earnings ESP reading is not indicative of an earnings miss. Our research shows that it is difficult to predict an earnings beat with any degree of confidence for stocks with negative Earnings ESP readings and/or Zacks Rank of 4 (Sell) or 5 (Strong Sell).
How Have the Numbers Shaped Up for Insmed?For Insmed, the Most Accurate Estimate is lower than the Zacks Consensus Estimate, suggesting that analysts have recently become bearish on the company's earnings prospects. This has resulted in an Earnings ESP of -3.48%.
On the other hand, the stock currently carries a Zacks Rank of #3.
So, this combination makes it difficult to conclusively predict that Insmed will beat the consensus EPS estimate.
Does Earnings Surprise History Hold Any Clue?While calculating estimates for a company's future earnings, analysts often consider to what extent it has been able to match past consensus estimates. So, it's worth taking a look at the surprise history for gauging its influence on the upcoming number.
For the last reported quarter, it was expected that Insmed would post a loss of$0.69 per share when it actually produced a loss of -$0.52, delivering a surprise of +24.64%.
Over the last four quarters, the company has beaten consensus EPS estimates two times.
Bottom LineAn earnings beat or miss may not be the sole basis for a stock moving higher or lower. Many stocks end up losing ground despite an earnings beat due to other factors that disappoint investors. Similarly, unforeseen catalysts help a number of stocks gain despite an earnings miss.
That said, betting on stocks that are expected to beat earnings expectations does increase the odds of success. This is why it's worth checking a company's Earnings ESP and Zacks Rank ahead of its quarterly release. Make sure to utilize our Earnings ESP Filter to uncover the best stocks to buy or sell before they've reported.
Insmed doesn't appear a compelling earnings-beat candidate. However, investors should pay attention to other factors too for betting on this stock or staying away from it ahead of its earnings release.
Stay on top of upcoming earnings announcements with the Zacks Earnings Calendar.
Společnost Insmed s okamžitou platností jmenovala Paula Hudsona, bývalého generálního ředitele společností Sanofi a Novartis Pharmaceuticals, a Utapala Koppikara, finančního ředitele společnosti Verily Health, nezávislými členy představenstva.
—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]
—BRINSUPRI, a First-in-Disease and First-in-Class Treatment for Patients With Non-Cystic Fibrosis Bronchiectasis (NCFB), Is Now Available by Prescription in 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 announced the commercial launch in Japan of BRINSUPRI® Tablets 25 mg (brensocatib hydrate), an oral, once-daily treatment for non-cystic fibrosis bronchiectasis (NCFB) in adults and pediatric patients 12 years and older.
"The commercial availability of BRINSUPRI in Japan is a meaningful step forward for the bronchiectasis community and a proud moment for our team," said Samuele Butera, Senior Vice President, General Manager, Global Respiratory for Insmed. "As the first approved therapy specifically designed to address the underlying inflammatory process of NCFB, we are pleased that BRINSUPRI can be made widely available to appropriate patients in Japan who have long needed a treatment option that addresses an unmet driver of their disease."
BRINSUPRI is the first and only approved and commercially available treatment for patients diagnosed with NCFB in Japan. The Japan Ministry of Health, Labour, and Welfare (MHLW) approved BRINSUPRI in August 2026 based on results from the Phase 3 ASPEN study.
"In patients living with bronchiectasis, recurrent exacerbations represent a substantial disease burden, making daily life harder to manage and affecting long-term clinical outcomes," said Makoto Nakamura, Senior Vice President, General Manager, Japan for Insmed. "By offering BRINSUPRI as a new treatment option for appropriate patients in Japan, we hope to contribute to better disease management for eligible patients. Insmed remains committed to supporting the bronchiectasis community through appropriate information provision to healthcare professionals and advancing the proper use of this therapy."
About Bronchiectasis
Bronchiectasis is a serious, chronic lung disease in which the bronchi become permanently dilated due to a cycle of infection, inflammation, and lung tissue damage. The condition is marked by frequent pulmonary exacerbations requiring antibiotic therapy and/or hospitalizations. Symptoms include chronic cough, excessive sputum production, shortness of breath, and repeated respiratory infections, which can worsen the underlying condition. Most bronchiectasis cases in adults are non-cystic fibrosis bronchiectasis (NCFB).
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.
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: failure to successfully commercialize BRINSUPRI in the U.S., Europe, or Japan, or to maintain U.S., European, or Japanese approval for BRINSUPRI; uncertainties in the degree of market acceptance of BRINSUPRI by physicians, patients, third-party payors and others in the health care community; inaccuracies in the Company's estimates of the size of the potential markets for BRINSUPRI 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; the Company's inability to obtain adequate reimbursement from government or third-party payors for BRINSUPRI or acceptable prices for BRINSUPRI; development of unexpected safety or efficacy concerns related to BRINSUPRI, including the risk that data generated in further clinical trials of brensocatib may not be consistent with the results of the ASPEN study, which may result in changes to the product label and may adversely affect sales, or result in withdrawal of BRINSUPRI from the market; failure by us to comply with agreements related to brensocatib, including our license agreement with AstraZeneca AB; risk that health care legislation or other government action materially adversely affects the Company's business; and failure of third parties on which the Company is dependent to manufacture sufficient quantities of brensocatib for commercial needs, or to comply with the Company's agreements or laws and regulations that impact the Company's business or agreements with the Company.
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]
Insmed na konferencích CHEST 2026 a IDWeek 2026 představí nová data o přípravcích TPIP, BRINSUPRI a ARIKAYCE, včetně studie rezistence u pacientů s plicním onemocněním způsobeným komplexem MAC.
—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]
Akcie společnosti Insmed v pondělí klesly téměř o 7 % poté, co finanční ředitelka Sara Bonstein oznámila, že k 30. říjnu odejde. Společnost potvrdila výhled tržeb přípravku Brinsupri na rok 2026 ve výši 1,25 až 1,40 mld. USD.
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%.
Insmed oznámil, že finanční ředitelka Sara Bonsteinová odstoupí 30. října a firma zahájila hledání nástupce. Zároveň potvrdila celoroční výhled na rok 2026.
—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]
FDA přijala žádost Insmed o rozšíření indikace Arikayce pro nově diagnostikované pacienty s MAC plicním onemocněním a dala jí přednostní přezkum. Rozhodnutí čeká do 28. ledna 2027.
Key Takeaways INSM's Arikayce filing seeks approval for newly diagnosed MAC lung disease patients.The FDA granted priority review, with a decision expected by Jan. 28, 2027.Arikayce sales rose 7% to $214.4 million in first-half 2026. Insmed (INSM - Free Report) announced that the FDA has accepted a regulatory filing seeking label expansion for Arikayce in mycobacterium avium complex (MAC) lung disease.
The FDA has granted the filing priority review, shortening the review period by four months. A final decision is expected by Jan. 28, 2027.
The regulatory filing is seeking approval for Arikayce as part of a combination antibacterial drug regimen for newly diagnosed MAC lung disease patients. It would also fulfil the post-marketing requirement associated with the drug’s existing accelerated approval.
Arikayce was approved by the FDA in 2018 under the accelerated pathway to treat refractory MAC lung disease as part of a combination antibacterial drug regimen in adult patients with limited or no alternative treatment options. It is approved for similar indications in Europe and Japan.
The filing is supported by results from the phase IIIb ENCORE study, which met its primary endpoint of improvement in the respiratory symptom score (RSS), a patient-reported outcome measure. The study also achieved several key secondary endpoints.
Insmed intends to engage with regulatory authorities in Japan during the fourth quarter of 2026 regarding Arikayce’s label expansion.
INSM Stock PerformanceShares of Insmed have underperformed the industry in the year-to-date period, as seen in the chart below.
Image Source: Zacks Investment Research
Arikayce: A Top-line Driver for InsmedArikayce was the first marketed product in Insmed’s portfolio. Despite its approval for a limited treatment population, sales of the drug have continued to grow, driven by encouraging demand across all markets.
Sales of the drug rose 7% year over year to $214.4 million in first-half 2026. For the full year, the company expects to record sales between $450 million and $470 million, suggesting 6% year-over-year growth at the midpoint.
The label expansion has been viewed positively by investors, given the potential for a significant expansion in Arikayce’s addressable market. The company has previously estimated the total addressable market (TAM) for refractory MAC lung disease at around 30,000 patients across the United States, Europe and Japan. Insmed estimates that the broader MAC lung disease population across these markets could exceed 200,000 patients. If approved for use in newly diagnosed patients, the expanded indication could significantly increase Arikayce’s addressable market and commercial potential.
INSM’s Zacks RankInsmed currently carries a Zacks Rank #3 (Hold).
Key Picks Among Biotech StocksSome better-ranked stocks in the biotech sector are Precigen (PGEN - Free Report) and AC Immune (ACIU - Free Report) . While PGEN sports a Zacks Rank #1 (Strong Buy), ACIU carries a Zacks Rank #2 (Buy). You can see the complete list of today’s Zacks #1 Rank stocks here.
Over the past 60 days, estimates for Precigen’s 2026 bottom line have improved from a loss of 2 cents to earnings per share (EPS) of 25 cents. Over the same period, EPS estimates for 2027 have risen from 25 cents to 86 cents. PGEN shares have gained 84% year to date.
Precigen’s earnings beat estimates in three of the trailing four quarters and missed in the remaining one, with the average surprise being 108.96%.
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, EPS estimates for 2027 remained unchanged at 17 cents. ACIU shares have lost nearly 16% year-to-date.
AC Immune’s earnings beat estimates in each of the trailing four quarters, with the average surprise being 33.25%.
Insmed uvedl, že uvedení BRINSUPRI na trh výrazně překonalo očekávání; odhaduje první plný rok tržeb na 1,25 až 1,4 miliardy USD, proti původním 500 až 700 milionům USD.
Insmed Incorporated (INSM) Morgan Stanley 24th Annual Global Healthcare Conference September 14, 2026 2:35 PM EDT
Company Participants
William Lewis - President, CEO & Chairman
Conference Call Participants
Maxwell Skor - Morgan Stanley, Research Division
Presentation
Maxwell Skor
Morgan Stanley, Research Division
Hello, everyone. I'm Max Skor, a biotech analyst with Morgan Stanley. And before we get started, for important disclosures, please see the Morgan Stanley research disclosure website, www.morganstanley.com/researchdisclosures.
And with that, I'd like to welcome Will Lewis, the CEO of Insmed. Thank you very much for joining us today.
William Lewis
President, CEO & Chairman
Thanks for having me here.
Question-and-Answer Session
Maxwell Skor
Morgan Stanley, Research Division
All right. Great. Maybe if we could start off, we're almost a year out from -- a little over a year from the approval of BRINSUPRI. I was hoping you can just kind of step back and give us some key takeaways, learnings, anything that you would glean as important from the launch so far?
William Lewis
President, CEO & Chairman
Yes. Well, I'll just start out by saying this launch has blown away all our expectations. We started out, I remember vividly describing that we were going to use a basket of other specialty respiratory launches to help benchmark whether or not we thought the launch was going well. And we took from that basket of best performers a first year revenue production of about $500 million to $700 million. And at the time, I got a lot of heat for that because people thought, well, why would you set yourself against the best launches out there? You might not be able to achieve that and you'd set yourself on your back heel.
Today, as you know, we sit with an estimate for the first full year of $1.25 billion to $1.4 billion, which
Insmed oznámil, že na kongresu ERS 2026 představí pět abstraktů z respiračního portfolia, včetně pozdně zveřejněných výsledků studie ENCORE k ARIKAYCE.
—New Data Explore Efficacy and Safety of BRINSUPRI ® (brensocatib) in Patients With Non-Cystic Fibrosis Bronchiectasis (NCFB) and History of Nontuberculous Mycobacterial (NTM) Lung Disease—
—New Research Examines Treprostinil Palmitil Inhalation Powder (TPIP) via COMPERA 2.0 Risk Assessment in Pulmonary Arterial Hypertension (PAH)—
, /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 five abstracts highlighting data from its respiratory portfolio have been accepted for presentation at the European Respiratory Society (ERS) Congress 2026 taking place Sept. 5–9, 2026, in Barcelona.
Presentation highlights include a late-breaking abstract from the Phase 3b ENCORE study, which evaluated 12 months of treatment with ARIKAYCE® (amikacin liposome inhalation suspension) plus multidrug therapy (azithromycin 250 mg and ethambutol 15 mg/kg) in patients diagnosed with a new occurrence of Mycobacterium avium complex (MAC) lung infection who had not received antibiotics. The scientific program will also include a post hoc analysis of COMPERA 2.0 risk score data from the Phase 2 study of treprostinil palmitil inhalation powder (TPIP) in patients with pulmonary arterial hypertension (PAH). Additionally, data will be presented on the psychosocial burden of exacerbations, treatment patterns, and healthcare resource utilization associated with bronchiectasis, as well as from 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).
"The data presented at the ERS Congress 2026 reflect our commitment to advancing research and improving outcomes for patients with serious respiratory diseases," said Martina Flammer, M.D., MBA, Chief Medical Officer of Insmed. "We are particularly pleased to present findings from our Phase 3b ENCORE study addressing rates of recurrence following treatment for NTM lung disease, an important challenge in long-term disease management. These findings, together with data from our broader respiratory portfolio, contribute to a growing body of evidence that can help shape the future of care for patients who have long faced limited treatment options."
Presentations:
Oral Session OA1207, Sunday, Sept. 6, 9:30 a.m. CEST to 10:45 a.m. CEST (3:30 a.m. ET to 4:45 a.m. ET)
Late-Breaking Abstract: Microbiologic Outcomes and Recurrence in Patients With Newly Diagnosed Mycobacterium avium Complex Lung Disease (MACLD) in the Phase 3b ENCORE Trial Poster Session PA908, Sunday, Sept. 6, 8:00 a.m. CEST to 9:30 a.m. CEST (2:00 a.m. ET to 3:30 a.m. ET)
COMPERA 2.0 Risk Assessment of Treprostinil Palmitil Inhalation Powder (TPIP) for Pulmonary Arterial Hypertension (PAH): A Post Hoc Analysis of a Phase 2 Study Poster Session PA1839, Sunday, Sept. 6, 12:30 p.m. CEST to 2:00 p.m. CEST (6:30 a.m. ET to 8:00 a.m. ET)
Brensocatib in Patients With Non-Cystic Fibrosis Bronchiectasis (NCFB) and History of Nontuberculous Mycobacteria (NTM) Infection: A Post Hoc Analysis of the ASPEN Trial Poster Session PA1840, Sunday, Sept. 6, 12:30 p.m. CEST to 2:00 p.m. CEST (6:30 a.m. ET to 8:00 a.m. ET)
Quantifying the Psychosocial Impact of Exacerbations in Bronchiectasis: A European Patient-Centered Study Poster Session PA2883, Monday, Sept. 7, 8:00 a.m. CEST to 9:00 a.m. CEST (2:00 a.m. ET to 3:00 a.m. ET)
Treatment Patterns and Healthcare Resource Utilization Associated With Bronchiectasis and Pulmonary Exacerbations in Spain 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 NCFB. The therapy is approved in the United States as BRINSUPRI (brensocatib 10 mg and 25 mg tablets) and indicated for the treatment of non-cystic fibrosis bronchiectasis (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 (brensocatib 25 mg tablets) is approved for the treatment of patients with non-cystic fibrosis bronchiectasis (NCFB) in adult 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. 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; failure to maintain U.S., European or Japanese approval for ARIKAYCE or U.S. or European approval for 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. and Europe; 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:
Sara Bonstein
Chief Financial Officer
[email protected]
Insmed zvýšil celoroční výhled tržeb pro Brinsupri na 1,25–1,40 miliardy USD z minimálně 1 miliardy USD. Silný start léku posiluje růstový příběh firmy.
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.
Insmed oznámil, že japonské ministerstvo zdravotnictví schválilo BRINSUPRI pro léčbu ne-cystické fibrózy bronchiektázie u dospělých a pacientů od 12 let. Je to první a jediná schválená léčba tohoto onemocnění v Japonsku.
—First-in-Disease and First-in-Class Therapy Approved in Japan for Patients With Non-Cystic Fibrosis Bronchiectasis (NCFB), a Progressive Disease That Can Lead to Permanent Lung Damage—
, /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 Japan's Ministry of Health, Labour and Welfare (MHLW) has approved BRINSUPRI® (brensocatib 25-mg tablet), an oral, once-daily treatment for non-cystic fibrosis bronchiectasis (NCFB) in adults and pediatric patients 12 years and older. BRINSUPRI, the first and only MHLW-approved treatment for NCFB, finally gives patients with NCFB and clinicians who treat the disease an option to manage this chronic and progressive disease that can lead to permanent lung damage and lung function decline. With this approval, BRINSUPRI is now approved for use in the U.S., Europe, and Japan.
"Today's approval of BRINSUPRI represents a profound milestone for people living with bronchiectasis in Japan," said Martina Flammer, M.D., MBA, Chief Medical Officer of Insmed. "Patients have long faced a relentless cycle of exacerbations and declining lung function, with available care largely limited to symptom management. This approval reflects the contributions of patients and researchers who made this clinical evidence possible, as well as Insmed's enduring commitment to developing therapies that address significant unmet needs in respiratory diseases, including bronchiectasis care."
The approval of BRINSUPRI by the MHLW for the treatment of patients living with NCFB is based on results from the Phase 3 ASPEN study, which demonstrated that brensocatib significantly reduced pulmonary exacerbations compared with placebo over the 52-week treatment period and met multiple key secondary endpoints, including significantly prolonging the time to first exacerbation and significantly increasing the proportion of patients remaining exacerbation-free over the treatment period. Patients treated with brensocatib 25 mg also demonstrated significantly lower lung function decline at week 52, as measured by post bronchodilator forced expiratory volume in 1 second (FEV1), a standard measure of lung function. Brensocatib was generally well tolerated in the study. The most common treatment-emergent adverse events (TEAEs) occurring in at least 5.0% of patients were COVID-19, nasopharyngitis, cough, and headache.
"In patients living with bronchiectasis, recurrent exacerbations represent a substantial disease burden, making daily life harder to manage and affecting long-term clinical outcomes," said Makoto Nakamura, Senior Vice President, General Manager, Japan for Insmed. "By targeting key drivers of chronic airway inflammation, BRINSUPRI offers a new treatment option for appropriate patients in Japan. We are proud of this important milestone and look forward to continuing to support the bronchiectasis community as we advance innovation in this disease area."
About Bronchiectasis
Non-cystic fibrosis bronchiectasis (NCFB) is a chronic, progressive, and inflammatory lung disease that causes the airways to become permanently widened due to a cycle of infection, inflammation, lung tissue damage, and mucociliary dysfunction. Patients with NCFB often experience repeated exacerbations, requiring antibiotic therapy and/or hospitalizations. Symptoms include chronic cough, excessive sputum production, shortness of breath, fatigue, and repeated respiratory infections, which can worsen the underlying disease.
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 NCFB. The therapy is approved in the United States as BRINSUPRI (brensocatib 10 mg and 25 mg tablets) and indicated for the treatment of non-cystic fibrosis bronchiectasis (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 (brensocatib 25 mg tablets) is approved for the treatment of patients with non-cystic fibrosis bronchiectasis (NCFB) in adult and pediatric patients 12 years and older.
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 — 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 successfully commercialize BRINSUPRI in the U.S., Europe or Japan, or to maintain U.S., European or Japanese approval for BRINSUPRI; uncertainties in the degree of market acceptance of BRINSUPRI by physicians, patients, third-party payors and others in the health care community; inaccuracies in the Company's estimates of the size of the potential markets for BRINSUPRI 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; the Company's inability to obtain adequate reimbursement from government or third-party payors for BRINSUPRI or acceptable prices for BRINSUPRI; development of unexpected safety or efficacy concerns related to BRINSUPRI, including the risk that data generated in further clinical trials of brensocatib may not be consistent with the results of the ASPEN study, which may result in changes to the product label and may adversely affect sales, or result in withdrawal of BRINSUPRI from the market; failure by us to comply with agreements related to brensocatib, including our license agreement with AstraZeneca AB; risk that health care legislation or other government action materially adversely affects the Company's business; and failure of third parties on which the Company is dependent to manufacture sufficient quantities of brensocatib for commercial needs, or to comply with the Company's agreements or laws and regulations that impact the Company's business or agreements with the Company.
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]
Insmed Incorporated (INSM) Q2 2026 Earnings Call August 6, 2026 8:00 AM EDT
Company Participants
Bryan Dunn - Vice President of Investor Relations
William Lewis - President, CEO & Chairman
Sara Bonstein - Chief Financial Officer
Martina Flammer - Chief Medical Officer
Conference Call Participants
Jessica Fye - JPMorgan Chase & Co, Research Division
Joseph Schwartz - Leerink Partners LLC, Research Division
Vamil Divan - Guggenheim Securities, LLC, Research Division
Jason Zemansky - BofA Securities, Research Division
Olivia Brayer - Cantor Fitzgerald & Co., Research Division
Ritu Baral - TD Cowen, Research Division
Gavin Clark-Gartner - Evercore ISI Institutional Equities, Research Division
Leonid Timashev - RBC Capital Markets, Research Division
Faisal Khurshid - Jefferies LLC, Research Division
Matthew Phipps - William Blair & Company L.L.C., Research Division
Benjamin Burnett - Wells Fargo Securities, LLC, Research Division
Maxwell Skor - Morgan Stanley, Research Division
Brandon Frith - Wolfe Research, LLC
Stephen Willey - Stifel, Nicolaus & Company, Incorporated, Research Division
Qize Ding - Rothschild & Co Redburn, Research Division
Danielle Brill Bongero - Truist Securities, Inc., Research Division
Presentation
Operator
Thank you for standing by, and welcome to the Insmed Second Quarter 2026 Financial Results Conference Call. [Operator Instructions]
I'd now like to turn the call over to Bryan Dunn, Head of Investor Relations. You may begin.
Bryan Dunn
Vice President of Investor Relations
Thank you, Rob, and good day, everyone. Welcome to Insmed's Second Quarter 2026 Earnings Conference Call. Before we get started, please note that today's call will include forward-looking statements. These statements represent our judgment as of today and inherently involve risks and uncertainties that may cause actual results to differ materially from the projections discussed.
Please refer to our most recent filings with the Securities and Exchange Commission for a full description of these risk factors. The information we will discuss on today's call is meant for the benefit of the investment community. It is
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.
—Total Company Revenues of $425.5 Million for the Second Quarter of 2026— —BRINSUPRI ® (brensocatib) Revenues of $309.2 Million for the Second Quarter of 2026, Reflecting 49% Growth Over the First Quarter of 2026— —ARIKAYCE ® (amikacin liposome inhalation suspension) Revenues of $116.3 Million for the Second Quarter of 2026, Reflecting 8% Growth Over the Second Quarter of 2025— —Company Raises 2026 BRINSUPRI Revenue Guidance to $1.25 Billion to $1.40 Billion— —Company Reiterates 2026 ARIKAYCE Revenue Guidance of $450 Million to $470 Million— —Company Raises Peak Revenue Estimate for its Three Lead Programs to More than $14 Billion Total— —Peak Revenue Estimate Consists of More than $7 Billion for BRINSUPRI, More than $6 Billion for TPIP, and More than $1 Billion for ARIKAYCE— BRIDGEWATER, N.J., Aug. 6, 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 reported financial results for the second quarter ended June 30, 2026, and provided a business update.
Insmed oznámila, že 12měsíční data z otevřené studie TPIP u pacientů s PAH ukázala trvalé zlepšení účinnosti a žádné nové bezpečnostní signály. Léčba byla obecně dobře snášena.
–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.
