Core Insights - Insmed's shares have increased by 78% over the past six months, driven by strong momentum from its late-stage pipeline and robust sales from marketed drugs, enhancing investor confidence [1] Group 1: Product Approvals and Market Potential - The FDA approved brensocatib, branded as 'Brinsupri', in August 2025, making it the first approved therapy for non-cystic fibrosis bronchiectasis (NCFB) [2] - Brinsupri's approval positions Insmed to access a multi-billion-dollar market and marks the company's second marketed product, generating $28.1 million in revenues in Q3 2025 due to strong patient uptake [3] - Insmed's shares surged following the approval of Brinsupri, reflecting its strong revenue potential [7] Group 2: Financial Performance - Over the past year, Insmed's shares have surged by 149.2%, significantly outperforming the industry growth of 17.5% [4] - Arikayce, Insmed's established product, generated $314.5 million in sales in the first nine months of 2025, reflecting a 21% year-over-year increase, which alleviates near-term cash flow concerns [5] - Following the third-quarter release, Insmed raised its full-year guidance for Arikayce revenues to a range of $420 million to $430 million, up from $405 million to $425 million [8] Group 3: Pipeline Developments - Insmed faced a setback with the phase IIb BiRCh study of brensocatib in chronic rhinosinusitis without nasal polyps, which failed to meet key efficacy goals, leading to the discontinuation of this indication [9] - Despite this, Insmed is strengthening its pipeline with the addition of INS1148 for interstitial lung disease and asthma, and is evaluating brensocatib in the phase II CEDAR study for hidradenitis suppurativa, with data expected in the first half of 2026 [10] - Insmed is also progressing treprostinil palmitil inhalation powder into late-stage studies for pulmonary hypertension indications [12]

NEW YORK, Dec. 30, 2025 (GLOBE NEWSWIRE) -- Pomerantz LLP is investigating claims on behalf of investors of Insmed Incorporated (“Insmed” or the “Company”) (NASDAQ: INSM).  Such investors are advised to contact Danielle Peyton at newaction@pomlaw.com or 646-581-9980, ext. 7980. The investigation concerns whether Insmed and certain of its officers and/or directors have engaged in securities fraud or other unlawful business practices.  [Click here for information about joining the class action] On December 17 ...

Core Viewpoint - The Schall Law Firm is investigating potential securities law violations by Insmed Incorporated following the announcement of disappointing clinical trial results for its drug brensocatib, which led to a significant drop in the company's stock price [1][2]. Group 1: Investigation Details - The investigation is centered on whether Insmed made false or misleading statements or failed to disclose important information to investors [2]. - Insmed's Phase 2b BiRCh study for brensocatib in chronic rhinosinusitis without nasal polyps did not meet its primary or secondary efficacy endpoints, resulting in the decision to discontinue the drug's development [2]. Group 2: Market Reaction - Following the announcement of the trial results, Insmed's shares experienced a decline of nearly 16.1% the next day [2].

Insmed Incorporated (NASDAQ:INSM) stock plunged on Thursday. • Insmed stock is showing notable weakness. What’s behind INSM decline?The company released data from the Phase 2b BiRCh study of brensocatib in patients with chronic rhinosinusitis without nasal polyps (CRSsNP).The trial did not meet its primary or secondary efficacy endpoints in either the 10 mg or 40 mg treatment arms.Brensocatib was well tolerated, with no new safety signals identified, including in the 40 mg arm, which is the highest dose Ins ...

U.S. stocks traded higher midway through trading, with the Nasdaq Composite gaining more than 200 points on Thursday.The Dow traded up 0.44% to 48,097.08 while the NASDAQ jumped 1.08% to 22,938.56. The S&P 500 also rose, gaining, 0.76% to 6,772.76.Check This Out: Wall Street’s Most Accurate Analysts Give Their Take On 3 Materials Stocks Delivering High-Dividend YieldsLeading and Lagging SectorsConsumer discretionary shares rose by 2% on Thursday.In trading on Thursday, energy stocks fell by 0.5%.Top Headlin ...

This story was originally published on BioPharma Dive. To receive daily news and insights, subscribe to our free daily BioPharma Dive newsletter. Dive Brief: A streak of positive news that pushed Insmed into the ranks of the most valuable biotechnology companies ended this week with the announcement of a failed clinical trial. The company’s share price dropped almost 17% to about $165 early Thursday, following the announcement late Wednesday. The stock, which was worth around $25 a year and a half ago ...

—Phase 2b BiRCh Study of Brensocatib in CRSsNP Did Not Meet Primary or Secondary Efficacy Endpoints; Safety Consistent with Previous Studies; Insmed Discontinues CRSsNP Program— —Company Acquires Phase 2 Ready Monoclonal Antibody for Potential Respiratory and Immunological & Inflammatory Indications— BRIDGEWATER, N.J., Dec. 17, 2025 /PRNewswire/ -- Insmed Incorporated (Nasdaq:INSM), a people-first global biopharmaceutical company striving to deliver first- and best-in-class therapies to transform the lives ...

Core Insights - Insmed has experienced a landmark year with a first FDA approval for a disease and strong launch data in pulmonary arterial hypertension (PAH) [1] - The next 18 months are expected to be even more eventful with successful trial readouts and new product approvals [2] Company Developments - The ASPEN trial readout was successful, leading to the approval of brensocatib for bronchiectasis treatment [2] - The company is focusing on three key programs: ARIKAYCE, which is approved for refractory MAC lung disease, and is expected to expand its market opportunity significantly from 30,000 patients to over 250,000 with the upcoming ENCORE trial readout [2]

Financial Data and Key Metrics Changes - In Q3 2025, BRINSUPRI achieved $28 million in net sales, reflecting a strong early launch performance [32] - ARIKAYCE posted its largest quarter of revenue ever, up 22% year-over-year, with U.S. growth of 11% and international growth exceeding 50% [39][40] - The company raised its full-year global ARIKAYCE net revenue guidance to $420 million-$430 million, up from $405 million-$425 million previously [41] Business Line Data and Key Metrics Changes - BRINSUPRI's launch saw approximately 2,550 new patients starting treatment and about 1,700 physicians prescribing it within the first six weeks [32] - ARIKAYCE continues to perform strongly, with double-digit growth across all geographic regions [39] Market Data and Key Metrics Changes - The early days of BRINSUPRI's launch have shown broad prescribing patterns, with physicians testing the medicine on a small number of patients before wider adoption [33] - The U.S. market access for BRINSUPRI has been encouraging, with most prescriptions approved for coverage without formal contracts [36] Company Strategy and Development Direction - The company aims to position BRINSUPRI alongside leading respiratory launches like DUPIXENT and OFEV, targeting significant commercial opportunities [9] - Insmed is focused on executing multiple late-stage and commercial programs, including brensocatib and ARIKAYCE, while expanding its pipeline of earlier-stage programs [10][12] Management's Comments on Operating Environment and Future Outlook - Management expressed cautious optimism regarding the BRINSUPRI launch, emphasizing the need for more data from the first full quarter to assess long-term trends [51] - The company is well-capitalized with approximately $1.7 billion in cash, allowing it to support the launch of BRINSUPRI and other portfolio programs [41][43] Other Important Information - The company received a positive opinion from Europe's CHMP for brensocatib, anticipating a potential EU launch in early 2026 [12][13] - Insmed was awarded the number one ranking on Science Magazine's Top Employers list for the fifth consecutive year, highlighting its strong company culture [31] Q&A Session Summary Question: Early feedback on physician experience with BRINSUPRI - Management noted positive feedback from physicians, with enthusiasm for the medicine and manageable reimbursement processes during the early launch phase [47][49] Question: Thresholds for payer coverage and prior authorization - The company aims for clear and non-burdensome criteria for approval, focusing on patients with two or more exacerbations and confirmed diagnoses [54][56] Question: Dynamics of patient journey and DTC impact - There is clear enthusiasm from patients, with social media activity reflecting excitement about the new medicine [66] Question: Investment needed for European launch - The strategy involves cautious investment in Europe, ensuring reimbursement aligns before significant additional investments [70] Question: Phase III design considerations for TPIP - Management is confident in overcoming orphan drug exclusivity and plans to leverage insights from previous studies to inform the design of upcoming trials [75][78]

Commercial Performance - BRINSUPRI received U S approval and was launched, with approximately 2,550 patients starting treatment and about 1,700 physicians writing at least one prescription[8, 55] - BRINSUPRI's initial sales benefited from inventory stocking, accounting for roughly 40% of Q3 sales[58] - Worldwide ARIKAYCE revenue reached $114.3 million, a 22.3% increase compared to the same period last year[60] - U S ARIKAYCE revenue was $74.0 million, a 10.6% increase year-over-year, while international ARIKAYCE revenue was $40.3 million, a 51.8% increase[60] Financial Highlights - The company anticipates ARIKAYCE revenue for the full year 2025 to be between $420 million and $430 million, representing a 15% to 18% increase compared to 2024[64, 65] - As of September 30, 2025, the company held approximately $1.7 billion in cash, cash equivalents, and marketable securities[68] - Total revenues for the three months ended September 30, 2025, were $142.3 million, compared to $93.4 million for the same period in 2024[69] Clinical Development - International filings for brensocatib are progressing on track, with a potential EMA decision in the next several months that could expand the total addressable market by approximately 600,000 patients[13, 16] - Topline readout for the BiRCh trial is expected by early January 2026[17] - Enrollment for the CEDAR trial was completed ahead of schedule, with topline readout now expected in the first half of 2026[21, 23] - The ENCORE study is progressing on schedule toward a readout in the first half of 2026, potentially expanding ARIKAYCE's label to address an additional 100,000+ patients in both the U S and Japan[31, 32]