Insmed Provides Business Update at 44th Annual J.P. Morgan Healthcare Conference

Rhea-AI Summary

Insmed (Nasdaq: INSM) reported preliminary unaudited full-year 2025 net product revenues of $606.4M (up 67% vs. 2024), driven by ARIKAYCE $433.8M and BRINSUPRI $172.7M. BRINSUPRI generated approximately $144.6M in its first full quarter. The company received European approval for BRINSUPRI and plans EU, UK, and Japan launches in 2026. Insmed expects 2026 ARIKAYCE revenue of $450M–$470M, announced key Phase 3 and Phase 2 readout timelines for ENCORE (Mar/Apr 2026) and CEDAR (Q2 2026), initiated PALM-ILD in Q4 2025, and acquired INS1148 in Dec 2025.

Positive

• Preliminary total 2025 revenues of $606.4M (+67% YoY)
• ARIKAYCE 2025 global revenues of $433.8M, +19% vs. 2024
• BRINSUPRI first full-quarter revenues of approximately $144.6M
• European Commission approval for BRINSUPRI; EU launch planned H1 2026
• Initiated Phase 3 PALM-ILD for TPIP in Q4 2025 and multiple TPIP Phase 3 trials planned in 2026

Negative

• Preliminary results are unaudited and "subject to adjustment"; actual results could be materially different
• BRINSUPRI recorded $0 international revenue in 2025, indicating geographic rollout not yet realized
• Topline readouts (ENCORE, CEDAR) are pending in 2026 and are material catalysts with binary outcomes

News Market Reaction – INSM

+3.35%

15 alerts

+3.35% News Effect

+8.7% Peak in 59 min

+$1.18B Valuation Impact

$36.31B Market Cap

0.0x Rel. Volume

On the day this news was published, INSM gained 3.35%, reflecting a moderate positive market reaction. Argus tracked a peak move of +8.7% during that session. Our momentum scanner triggered 15 alerts that day, indicating notable trading interest and price volatility. This price movement added approximately $1.18B to the company's valuation, bringing the market cap to $36.31B at that time.

Data tracked by StockTitan Argus on the day of publication.

Key Figures

BRINSUPRI quarterly revenue: $144.6M BRINSUPRI 2025 revenue: $172.7M ARIKAYCE 2025 revenue: $433.8M +5 more

8 metrics

BRINSUPRI quarterly revenue $144.6M Unaudited first full quarter of BRINSUPRI launch in 2025

BRINSUPRI 2025 revenue $172.7M Unaudited full-year 2025 BRINSUPRI total revenues

ARIKAYCE 2025 revenue $433.8M Unaudited global ARIKAYCE revenues, full-year 2025

ARIKAYCE 2026 guidance $450–$470M Expected full-year 2026 global ARIKAYCE revenues

Total 2025 revenues $606.4M Preliminary full-year 2025 total revenues, +67% vs 2024

BRINSUPRI prescribers 4,000 medical professionals Approximate count as of year-end 2025

New BRINSUPRI patients 9,000 patients Approximate new therapy starts in Q4 2025

Total 2024 revenues $363.7M Full-year 2024 total revenues from table

Market Reality Check

Price: $164.91 Vol: Volume 2,608,161 vs 20-da...

normal vol

$164.91 Last Close

Volume Volume 2,608,161 vs 20-day average 3,717,415 (relative volume 0.7x) ahead of this update. normal

Technical Price 170.27 is trading above 200-day MA at 127.6, indicating a pre-news uptrend.

Peers on Argus

INSM fell 3.26% with several biotech peers also down: ONC -3.75%, ARGX -3.76%, G...

INSM fell 3.26% with several biotech peers also down: ONC -3.75%, ARGX -3.76%, GMAB -0.85%, REGN -0.6%, BNTX -0.33%, suggesting a sector-leaning move rather than a purely idiosyncratic reaction.

Historical Context

5 past events · Latest: Jan 02 (Neutral)

Pattern 5 events

Date	Event	Sentiment	Move	Catalyst
Jan 02	Conference presentation	Neutral	+1.8%	Announcement of upcoming J.P. Morgan Healthcare Conference presentation and webcast details.
Dec 17	Clinical update	Negative	-1.1%	Phase 2b BiRCh brensocatib study in CRSsNP failed endpoints; program discontinued.
Dec 09	Scientific congress data	Positive	-1.2%	Multiple ERS 2025 presentations including positive TPIP PAH and brensocatib ASPEN subgroup data.
Dec 04	Equity compensation	Neutral	-0.8%	Inducement RSUs and options granted to new employees under Nasdaq listing rule.
Nov 18	EU drug approval	Positive	+2.1%	European Commission approval of BRINSUPRI for NCFB patients 12 and older in EU.

Pattern Detected

Recent news reactions mostly aligned with the underlying news tone, with one notable divergence on positive scientific data.

Recent Company History

Over the last several months, Insmed has reported regulatory progress, scientific visibility, and some clinical setbacks. On Nov 18, 2025, BRINSUPRI gained European Commission approval for NCFB, which coincided with a positive price move. Earlier, Q3 2025 results showed growing ARIKAYCE and BRINSUPRI revenues alongside higher operating losses. A December 2025 update highlighted a failed brensocatib CRSsNP study and acquisition of INS1148. Today’s comprehensive business update and 2025 revenue breakouts extend this narrative of commercial expansion alongside an advancing, diversified pipeline.

Market Pulse Summary

This announcement outlines substantial 2025 revenue expansion, with total unaudited revenues of $606...

Analysis

This announcement outlines substantial 2025 revenue expansion, with total unaudited revenues of $606.4M, including ARIKAYCE at $433.8M and BRINSUPRI at $172.7M. It also details 2026 ARIKAYCE guidance of $450–$470M and a dense slate of Phase 2 and 3 milestones across respiratory, immunology, and gene therapy programs. Investors may track upcoming trial readouts, regional BRINSUPRI launches, and expense trends alongside this growth trajectory.

Key Terms

non-cystic fibrosis bronchiectasis (NCFB), supplementary new drug application (sNDA), pulmonary arterial hypertension (PAH), idiopathic pulmonary fibrosis (IPF), +4 more

8 terms

non-cystic fibrosis bronchiectasis (NCFB) medical

"approved BRINSUPRI (brensocatib 25 mg tablets) for the treatment of non-cystic fibrosis bronchiectasis (NCFB)"

A chronic lung condition where airways become permanently widened and scarred, causing persistent cough, excess mucus and frequent chest infections; it is the form of bronchiectasis not caused by cystic fibrosis. Investors care because it creates long-term demand for therapies, diagnostics and healthcare services—like a building that needs ongoing repairs, the condition drives repeat treatment, hospitalization and potential market opportunities for drugs and medical devices.

supplementary new drug application (sNDA) regulatory

"plans to submit a supplementary new drug application (sNDA) to the U.S. Food and Drug Administration"

A supplementary new drug application (sNDA) is a formal request to a drug regulator to approve a change to an already approved medicine, such as a new use, strength, formulation, or labeling. Think of it like asking for a permit to change a product so it can serve more customers or be used in a different way. Investors care because approved changes can expand sales, extend a drug’s commercial life, and alter revenue and risk profiles.

pulmonary arterial hypertension (PAH) medical

"Phase 3 study of TPIP in patients with pulmonary arterial hypertension (PAH) in early 2026"

Pulmonary arterial hypertension (PAH) is a progressive condition where the blood vessels that carry blood from the heart to the lungs become narrowed or stiff, causing high pressure and extra strain on the heart. For investors it matters because PAH creates long-term demand for medical care and specialized drugs; advances, trial results, or regulatory approvals can meaningfully change treatment costs, hospital use, and the commercial prospects for therapies — like fixing a clogged hose to relieve an overworked pump.

idiopathic pulmonary fibrosis (IPF) medical

"additional Phase 3 studies of TPIP in progressive pulmonary fibrosis (PPF) and idiopathic pulmonary fibrosis (IPF)"

A chronic lung disease in which the tissue of the lungs gradually becomes scarred and stiff, making it harder to breathe and get enough oxygen. For investors, IPF matters because it drives demand for treatments, shapes the commercial opportunity and clinical trial risk for drug developers, and can influence a company’s regulatory milestones and long‑term revenue potential; think of it as a market shaped by urgent medical need and high development risk.

investigational new drug (IND) regulatory

"INS1033 ... with an IND filing expected in 2026"

An investigational new drug (IND) is a drug or biologic that is being tested but has not yet been approved for general use; it is the application and formal status that allows a company to begin human clinical trials under regulator oversight. Investors care because an IND marks the transition from lab work to human testing — like getting a permit to run real-world experiments — which creates important milestones, costs, timelines and regulatory risk that drive a development-stage company's value.

Duchenne muscular dystrophy (DMD) medical

"INS1201, an intrathecally-delivered gene therapy for patients with Duchenne muscular dystrophy (DMD)"

Duchenne muscular dystrophy (DMD) is a severe, inherited disorder caused by a faulty gene that leaves muscle cells unable to maintain their structure, leading to progressive muscle weakness and loss of mobility, often beginning in childhood. Investors care because DMD is a high unmet-need condition that drives demand for new therapies; successful drugs can command premium pricing and regulatory incentives, while clinical trial failures or safety issues can sharply affect companies and their stock value.

Amyotrophic Lateral Sclerosis (ALS) medical

"INS1202 ... gene therapy for patients with Amyotrophic Lateral Sclerosis (ALS)"

Amyotrophic lateral sclerosis (ALS) is a progressive neurological disease that damages nerve cells responsible for controlling voluntary muscles, leading to muscle weakness, loss of movement, and eventually paralysis. It matters to investors because health-related research, treatments, and biotech companies working on ALS can influence stock markets and create opportunities or risks within the healthcare sector.

monoclonal antibody medical

"INS1148, a Phase 2-ready monoclonal antibody targeting a specific isoform"

A monoclonal antibody is a laboratory-made protein designed to recognize and attach to a specific target in the body, such as a disease-causing substance or cell. It functions like a highly precise lock-and-key tool, helping to treat or detect illnesses. For investors, companies developing monoclonal antibodies can represent promising opportunities in the healthcare sector, especially as these treatments often address unmet medical needs.

AI-generated analysis. Not financial advice.

— BRINSUPRI^® (brensocatib) Unaudited Total Revenues of Approximately $144.6 Million for First Full Quarter of Launch; Approximately $172.7 Million for Full-Year 2025—

—ARIKAYCE^® (amikacin liposome inhalation suspension) Exceeds the Upper End of Guidance Range for Full-Year 2025 with Unaudited Global Revenues of Approximately $433.8 Million—

—Full-Year 2026 Global ARIKAYCE Revenues Expected to be Between $450 Million and $470 Million—

—Topline Data from Phase 3 ENCORE Study of ARIKAYCE in Patients with Newly Diagnosed or Recurrent MAC Lung Disease Now Anticipated in March or April of 2026—

— Topline Data from Phase 2b CEDAR Study of Brensocatib in Patients with HS Now Anticipated in the Second Quarter of 2026—

— Phase 3 PALM-ILD Study of TPIP in PH-ILD Initiated in the Fourth Quarter of 2025; Additional Phase 3 Studies Planned for PAH, PPF, and IPF in 2026—

BRIDGEWATER, N.J., Jan. 9, 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 provided an update on the Company's commercial and clinical programs and its outlook for 2026. These updates will be discussed as part of the Company's presentation at the 44^th Annual J.P. Morgan Healthcare Conference in San Francisco on Monday, January 12, 2026, at 3:00 p.m. PT (6:00 p.m. ET).

"2025 was a landmark year for the patients we serve, our company, and our people, during which we demonstrated what's possible when breakthrough science meets steadfast execution. Our strong BRINSUPRI launch and encouraging TPIP readout in PAH reinforced both the clinical potential of our growing portfolio and the remarkable discipline of our teams," said Will Lewis, Chair and Chief Executive Officer of Insmed. "As monumental as this past year was, the road ahead is poised to be even more exciting. With numerous upcoming clinical and commercial catalysts across our designated therapeutic areas — Respiratory, Immunology & Inflammation, and Neuro & Other Rare — we believe that the next 18 months could accelerate our trajectory even further and bring us closer to helping more patients living with serious diseases."

Preliminary Full-Year 2025 Global Net Product Revenues (Unaudited)

The following table summarizes Insmed's preliminary unaudited financial revenues expected for full-year 2025 and revenue growth across all commercial regions:

INSMED INCORPORATED Revenue by Region (in millions)
Preliminary Full-Year 2025 (Unaudited) and 2024 Net Product Revenues by Region
(in millions)		2025		2024		Growth
ARIKAYCE
U.S.		$                 280.3		$                 254.8		10 %
International		153.5		108.9		41 %
Total		$                 433.8		$                 363.7		19 %
BRINSUPRI
U.S.		$                 172.7		$                         -		N/A
International		-		-		N/A
Total		$                 172.7		$                         -		N/A
Total Revenues
U.S.		$                 453.0		$                 254.8		78 %
International		153.5		108.9		41 %
Total		$                 606.4		$                 363.7		67 %

 

These preliminary unaudited results are subject to adjustment. Insmed will report its final and complete fourth-quarter and full-year 2025 financial results in February 2026. The actual results could be materially different from these preliminary unaudited financial results.

As of year-end 2025, approximately 4,000 medical professionals had prescribed BRINSUPRI, with approximately 9,000 new patients starting therapy during the fourth quarter of 2025 alone.

Progress and Anticipated Milestones by Therapeutic Area:

Respiratory

BRINSUPRI

• In November 2025, the European Commission approved BRINSUPRI (brensocatib 25 mg tablets) for the treatment of non-cystic fibrosis bronchiectasis (NCFB) in patients 12 years of age and older with two or more exacerbations in the prior 12 months. Insmed plans to launch BRINSUPRI in the European Union (EU) in the first half of 2026.
• Insmed anticipates commercial launches in the United Kingdom and Japan in 2026, pending approval in each territory.

ARIKAYCE

• Insmed anticipates 2026 global ARIKAYCE revenues to be between $450 million and $470 million.
• The Company anticipates the topline readout of the Phase 3 ENCORE trial in March or April of 2026 in patients with newly diagnosed or recurrent Mycobacterium avium complex (MAC) lung disease who have not started antibiotics.
• Pending successful results from the ENCORE trial, Insmed plans to submit a supplementary new drug application (sNDA) to the U.S. Food and Drug Administration (FDA) for ARIKAYCE in all patients with MAC lung disease in the U.S. in the second half of 2026.

TPIP

• Insmed initiated PALM-ILD, a Phase 3 study of treprostinil palmitil inhalation powder (TPIP) in patients with pulmonary hypertension associated with interstitial lung disease (PH-ILD), in the fourth quarter of 2025.
• Insmed plans to initiate a Phase 3 study of TPIP in patients with pulmonary arterial hypertension (PAH) in early 2026.
• The Company expects to report data from the open-label extension (OLE) of its Phase 2b study of TPIP in PAH in the second half of 2026.
• The Company anticipates initiating additional Phase 3 studies of TPIP in progressive pulmonary fibrosis (PPF) and idiopathic pulmonary fibrosis (IPF) in the second half of 2026.

INS1148

• In December 2025, Insmed acquired INS1148, a Phase 2-ready monoclonal antibody targeting a specific isoform of Stem Cell Factor 248 (SCF248). The Company plans to advance Phase 2 development programs for INS1148 initially in interstitial lung disease and moderate-to-severe asthma.

Immunology and Inflammation

Brensocatib

• In October 2025, Insmed completed enrollment in the Phase 2b CEDAR study of brensocatib in patients with hidradenitis suppurativa (HS). Insmed anticipates reporting topline data from CEDAR in the second quarter of 2026.

INS1033

• Insmed's second dipeptidyl peptidase 1 (DPP1) inhibitor, INS1033, is currently advancing toward the clinic in rheumatoid arthritis (RA) and inflammatory bowel disease (IBD), with an IND filing expected in 2026.

Neuro & Other Rare

INS1201

• Insmed is currently enrolling cohorts 2 and 3 in the Phase 1 ASCEND clinical study of INS1201, an intrathecally-delivered gene therapy for patients with Duchenne muscular dystrophy (DMD).

INS1202

• In December 2025, the Company opened the first clinical site for the Phase 1 ARMOR study of INS1202, an intrathecally-delivered gene therapy for patients with Amyotrophic Lateral Sclerosis (ALS).

INS1203

• Insmed's third gene therapy candidate, INS1203, targeting Stargardt disease, is currently advancing toward the clinic, with an IND filing expected in 2026.

Pre-Clinical Programs

• Insmed's research efforts include more than 30 identified pre-clinical programs in development, all of which have the potential to become first-in-class or best-in-class therapies for the indications being pursued.
• The Company anticipates submitting an average of one to two INDs per year from its pre-clinical research programs.
• Insmed continues to anticipate that the totality of its pre-clinical research programs will comprise less than 20% of overall expenditures.

Presentation at the 44^th Annual J.P. Morgan Healthcare Conference

Will Lewis, Chair and Chief Executive Officer of Insmed, will present at the 44^th Annual J.P. Morgan Healthcare Conference on Monday, January 12, 2026, at 3:00 p.m. PT (6:00 p.m. ET). A live audio webcast of the presentation will be available on the Investor Relations section of the Company's website at www.insmed.com. A replay will also be archived for a period of 30 days following the conclusion of the live event.

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). BRINSUPRI (brensocatib 10 mg and 25 mg tablets) is indicated in the United States for the treatment of non-cystic fibrosis bronchiectasis (NCFB) in adult and pediatric patients 12 years of age or older. In the European Union, BRINSUPRI (brensocatib 25 mg tablets) is approved for the treatment of NCFB in patients 12 years of age and older with two or more exacerbations in the prior 12 months.

Brensocatib is designed to inhibit the activation of enzymes (neutrophil serine proteases) in neutrophils that are key drivers of chronic airway inflammation in NCFB. Brensocatib is also being evaluated for its potential role in hidradenitis suppurativa, another neutrophil-mediated disease. 

About TPIP 

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

About INS1148

INS1148 is an investigational monoclonal antibody that Insmed is developing as a potential first-in-class therapy to address respiratory and immunological and inflammatory diseases with high unmet need. Through its novel mechanism of action, INS1148 has the potential to preferentially target a specific isoform of Stem Cell Factor 248 (SCF248), which prevents only the inflammatory cascade downstream of c-Kit signaling, while leaving its critical homeostatic and tissue healing pathways intact. INS1148 is an investigational drug product that has not been approved for any indication in any jurisdiction.

About INS1201

INS1201 is an investigational micro-dystrophin adeno-associated virus gene replacement therapy that Insmed is developing as a potential treatment for patients with Duchenne muscular dystrophy (DMD). Administered intrathecally, this approach has the potential to target both skeletal and cardiac muscles at lower doses. INS1201 is an investigational drug product that has not been approved for any indication in any jurisdiction.

About INS1202

INS1202 is an investigational micro-dystrophin adeno-associated virus gene replacement therapy that Insmed is developing as a potential treatment for patients with Amyotrophic lateral sclerosis (ALS). Administered intrathecally, this approach has the potential to target both skeletal and cardiac muscles at lower doses. INS1202 is an investigational drug product that has not been approved for any indication in any jurisdiction.

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

U.S. INDICATION 

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

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

Limitation of Use:

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

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

Please see Full Prescribing Information. 

BRINSUPRI^® (brensocatib) U.S. INDICATION AND IMPORTANT SAFETY INFORMATION

Indication in the U.S.

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

Important Safety Information in the U.S.

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

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

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

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

Less Common Adverse Reactions 

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

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

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

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

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

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

Please see full US Prescribing Information. 

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

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

Forward-looking Statements 

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

The forward-looking statements in this press release are based upon the Company's current expectations and beliefs, and involve known and unknown risks, uncertainties and other factors, which may cause the Company's actual results, performance and achievements and the timing of certain events to differ materially from the results, performance, achievements or timings discussed, projected, anticipated or indicated in any forward-looking statements. Such risks, uncertainties and other factors include, among others, the following: failure to continue to successfully commercialize ARIKAYCE in the U.S., Europe or Japan or failure to successfully commercialize BRINSUPRI in the U.S. or Europe, or to maintain U.S., European or Japanese approval for ARIKAYCE or U.S. or E.U. approval for BRINSUPRI; our inability to obtain full approval of ARIKAYCE from the FDA, including the risk that we will not successfully or in a timely manner complete the confirmatory post-marketing clinical trial required for full approval of ARIKAYCE, or our failure to obtain regulatory approval to expand ARIKAYCE's indication to a broader patient population; failure to obtain, or delays in obtaining, regulatory approvals for our product candidates in the U.S., Europe or Japan, for ARIKAYCE outside the U.S., Europe or Japan, including separate regulatory approval for Lamira^® in each market and for each usage, or for brensocatib in NCFB in the U.K. or 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 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; the 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 or to permit the use of ARIKAYCE in the broader population of patients with MAC lung disease, among other things; 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 government healthcare legislation or other government action materially increases our costs and damages our financial condition; 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; the 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, 2024 and any subsequent Company filings with the Securities and Exchange Commission (SEC).

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

Contact:

Investors:

Bryan Dunn
Vice President, Investor Relations
(646) 812-4030
investor.relations@insmed.com

Media:

Claire Mulhearn
Vice President, Corporate Communications
(862) 842-6819
media@insmed.com

 

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SOURCE Insmed Incorporated

FAQ

What were Insmed (INSM) preliminary full-year 2025 revenues and growth?

Insmed reported preliminary unaudited 2025 net product revenues of $606.4M, a 67% increase versus 2024.

How much did ARIKAYCE (INSM) earn globally in 2025 and what is 2026 guidance?

ARIKAYCE generated approximately $433.8M in 2025; Insmed expects 2026 global ARIKAYCE revenues of $450M–$470M.

When will Insmed (INSM) report topline ENCORE and CEDAR readouts?

Topline ENCORE Phase 3 data for ARIKAYCE is anticipated in March or April 2026; CEDAR Phase 2b brensocatib topline is expected in Q2 2026.

What commercial progress did BRINSUPRI (brensocatib) make for Insmed (INSM) in 2025?

BRINSUPRI recorded about $172.7M in full-year 2025 revenue, with ~$144.6M in its first full quarter and EU approval granted in Nov 2025.

What clinical and corporate milestones did Insmed (INSM) announce for 2026?

Insmed initiated TPIP Phase 3 PALM-ILD in Q4 2025, plans additional TPIP Phase 3 trials in 2026, acquired INS1148 in Dec 2025, and targets multiple INDs and readouts across 2026.