Global biopharmaceutical company developing and commercializing therapies for patients with serious and rare diseases, headquartered in Bridgewater, New Jersey, with operations in the United States, Europe, and Japan.
相关临床试验
158
92 进行中
药物批准
3
批准总数
监管机构
1
监管机构数
成立时间
1988
进行中（未招募）
90
57.0%
Available
1
0.6%
已完成
42
26.6%
尚未招募
2
1.3%
招募中
18
11.4%
终止
3
1.9%
Unknown
1
0.6%
撤回
1
0.6%
- The FDA accepted Insmed's supplemental New Drug Application for ARIKAYCE in Mycobacterium avium complex lung disease and granted Priority Review with a PDUFA target action date of January 28, 2027. - The application seeks full approval based on the Phase 3b ENCORE study, which met its primary endpoint and multiplicity-controlled secondary culture conversion endpoints in 425 adults. - Full approval would fulfill the post-marketing requirement tied to ARIKAYCE's 2018 accelerated approval and could extend the label to patients earlier in their disease course. - Insmed plans to discuss the ENCORE data with Japan's PMDA in the fourth quarter of 2026 to support a potential label expansion in Japan.
- Japan's Ministry of Health, Labour and Welfare (MHLW) 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 is the first and only MHLW-approved therapy for NCFB, and with this approval it is now available in the U.S., Europe, and Japan. - Approval was based on the Phase 3 ASPEN study, which showed brensocatib significantly reduced pulmonary exacerbations versus placebo and slowed lung function decline over 52 weeks. - BRINSUPRI is a reversible inhibitor of dipeptidyl peptidase 1 (DPP1) that targets neutrophil serine proteases driving chronic airway inflammation in NCFB.
- Insmed Incorporated's first-quarter Brinsupri sales exceeded consensus estimates but fell short of more bullish investor expectations, triggering stock underperformance. - Second-quarter 2026 prescription trends have been strong and point to sales closer to the high end of consensus expectations, according to Carillon Eagle Mid Cap Growth Fund. - ClearBridge Investments acknowledged concerns around Brinsupri's launch pace but remains confident in the drug's meaningful long-term peak sales potential. - Insmed shares posted a one-month return of -10.60% as of late July 2026, with hedge fund holdings declining from 75 to 67 portfolios quarter-over-quarter.
- Once-daily treprostinil palmitil inhalation powder (TPIP) demonstrated sustained improvement across all secondary efficacy endpoints at 12 months in the ongoing open-label extension study, including 6MWD, NT-proBNP, WHO Functional Class, and REVEAL Lite 2.0 score. - Patients who crossed over from placebo achieved similar clinical outcomes to those continuing TPIP, with both groups showing approximately 60% reduction in NT-proBNP and mean 6MWD improvements exceeding 54 meters. - Approximately 65% of all patients achieved Refined Low Risk status by REVEAL Lite 2.0, associated with less than 5% estimated mortality risk at three years. - TPIP was safe and well-tolerated at doses up to 1,280 µg once daily with no newly identified safety signals; the most common adverse events were headache, cough, and nasopharyngitis.
- EMBARC and Insmed intend to collaborate on a three-year, open-label, single-arm interventional study evaluating brensocatib 25 mg in approximately 3,000 bronchiectasis patients across six European countries. - The study builds on ASPEN trial data showing brensocatib reduced exacerbation frequency, slowed lung function decline, and produced structural airway changes. - Researchers aim to determine whether earlier, upstream use of brensocatib can fundamentally alter the disease trajectory rather than merely slow progression. - Bronchiectasis affects approximately 600,000 people across Europe and millions globally, representing a significant unmet need in chronic respiratory care.
- Insmed has appointed Samuele Butera as Senior Vice President, General Manager, Global Respiratory, effective June 23, 2026, reporting directly to CEO Will Lewis. - Butera brings over two decades of commercial leadership experience, including leading the global launch of KYMRIAH, the first CAR-T therapy, at Novartis and the launch of OPSYNVI at Johnson & Johnson. - In his new role, Butera will oversee the ongoing launch of BRINSUPRI, the potential label expansion of ARIKAYCE, and the advancement of Insmed's TPIP development program. - The appointment signals Insmed's strategic focus on strengthening commercial execution across its respiratory portfolio, which includes two approved therapies for chronic lung diseases.
- Incyte received Buy ratings from multiple analysts including Stifel Nicolaus with a $123 price target and Argus Research with a $115 target, reflecting confidence in the pharmaceutical company's prospects. - The company reported strong Q1 2024 financial results with quarterly revenue of $1.27 billion and net profit of $303.33 million, representing significant growth from the prior year period. - Despite positive analyst sentiment, corporate insider activity shows negative sentiment with 99 insiders increasing share sales, including President Pablo Cagnoni's $1.8 million stock sale. - Analyst consensus maintains a Moderate Buy rating with an average price target of $108.06, suggesting 13.43% upside potential from current trading levels.
- Insmed's Phase 2b CEDAR study evaluating brensocatib in moderate to severe hidradenitis suppurativa failed to meet primary and secondary efficacy endpoints. - The 214-patient randomized trial showed brensocatib performed worse than placebo, with inflammatory count reductions of 45.5% and 40.3% versus 57.1% for placebo. - Despite the efficacy failure, brensocatib maintained a consistent safety profile with no new safety signals identified at doses up to 40 mg. - Insmed has discontinued the brensocatib development program for hidradenitis suppurativa treatment following these disappointing results.
- Insmed's Phase 2b CEDAR study of brensocatib in moderate to severe hidradenitis suppurativa failed to meet primary and secondary efficacy endpoints at both 10 mg and 40 mg doses. - The study showed paradoxical results with placebo achieving 57.1% reduction in abscess and inflammatory nodule count compared to 45.5% and 40.3% for the 10 mg and 40 mg brensocatib arms, respectively. - Despite the efficacy failure, brensocatib demonstrated good safety with no new safety signals identified, leading Insmed to discontinue the entire HS development program. - The trial enrolled 214 patients across 72 global sites in a randomized, double-blind, placebo-controlled design over 16 weeks.
- Melodia Therapeutics received a U.S. patent covering MLD-151, a structurally novel DPP1 inhibitor designed to treat neutrophil-driven inflammatory diseases. - The compound features a distinct chemotype differentiated from existing DPP1 inhibitors like brensocatib, potentially offering optimized potency, selectivity, and tissue distribution. - MLD-151 is advancing toward IND submission with plans for Phase 1/Phase 2a clinical studies targeting diseases driven by excessive neutrophil activation. - The patent strengthens Melodia's intellectual property position in the competitive DPP1 inhibitor landscape and supports the company's best-in-class development strategy.
