Insmed
🇺🇸United States
- Country
- 🇺🇸United States
- Ownership
- -
- Employees
- 912
- Market Cap
- $13.2B
- Introduction
Insmed, Inc. is a global biopharmaceutical company, which engages in the development and commercialization of therapies for patients with rare diseases. Its focuses on Brensocatib, and Treprostinil Palmitil Inhalation Powder (TPIP) pipeline. The company was founded in 1988 and is headquartered in Bridgewater, NJ.
Non-Cystic Fibrosis Bronchiectasis Market Expected to Reach USD 7.5 Billion by 2035, Driven by Novel Therapies
• The Non-Cystic Fibrosis Bronchiectasis (NCFB) market is projected to grow from USD 1.7 billion in 2024 to USD 7.5 billion by 2035, representing a robust CAGR of 14.62%.
• Advancements in diagnostic technologies, including high-resolution computed tomography, molecular tests, and AI-based imaging, are significantly improving early detection and treatment planning for NCFB patients.
• Several promising therapies are in late-stage development, including Insmed's brensocatib, which recently had its NDA accepted by the FDA after showing significant reduction in pulmonary exacerbations in Phase 3 trials.
CAR T-cell Therapy Pipeline Surges with 180+ Companies Advancing Novel Cancer Treatments
• The CAR T-cell therapy pipeline has experienced significant growth, with over 180 companies actively developing more than 200 innovative cell therapy candidates across various stages of clinical development.
• Recent breakthroughs include Hemogenyx's first human administration of HG-CT-1 for acute myeloid leukemia and NICE's approval of lisocabtagene maraleucel for large B-cell lymphoma treatment.
• Strategic industry developments are accelerating progress, with companies like CARsgen Therapeutics forming alliances to advance allogeneic CAR-T products and multiple firms reporting successful trial milestones.
EMA Evaluates Fast-Track Status for Three Novel Therapeutics from Scholar, Insmed, and Soleno
• The European Medicines Agency is reviewing accelerated assessment requests for three innovative drugs - apitegromab, brensocatib, and diazoxide choline - based on their potential major public health impact.
• Scholar Rock's apitegromab, Insmed's brensocatib, and Soleno's diazoxide choline are being evaluated for their therapeutic innovation potential in addressing significant unmet medical needs.
• The fast-track designation, if granted, would expedite the regulatory review process for these promising therapeutics, potentially bringing them to patients more quickly.
AN2 Therapeutics Shifts Phase 3 MAC Lung Disease Trial to Quality of Life Endpoint
• AN2 Therapeutics has selected Quality of Life-Bronchiectasis (QOL-B) respiratory domain as the new primary efficacy endpoint for their Phase 3 EBO-301 trial in treatment-refractory MAC lung disease.
• The company plans to accelerate data unblinding in Q2 2025, following promising Phase 2 results where epetraborole showed statistical superiority versus placebo in QOL-B measurements.
• This strategic shift aligns with FDA's 2023 guidance emphasizing patient-reported outcomes as primary endpoints in NTM drug development trials.
Pipeline for Pulmonary Arterial Hypertension Treatment Expands with 55+ Companies Developing Novel Therapies
• DelveInsight's latest report reveals over 55 companies actively developing 55+ pipeline drugs for Pulmonary Arterial Hypertension treatment, indicating robust research activity in this therapeutic area.
• Breakthrough therapies like Sotatercept by Acceleron Pharma and LIQ861 by Liquidia Technologies are advancing through clinical trials, offering new hope for PAH patients.
• Multiple clinical trials are underway in early 2025, including studies by Actelion, Keros Therapeutics, Insmed Incorporated, and Merck Sharp & Dohme, focusing on novel treatment approaches.
FDA Grants Priority Review to Brensocatib for Non-Cystic Fibrosis Bronchiectasis Treatment
• The FDA has accepted Insmed's New Drug Application for brensocatib, setting a PDUFA target action date of August 12 under Priority Review designation.
• Brensocatib could become the first approved treatment for bronchiectasis and pioneer a new class of medicines called dipeptidyl peptidase 1 inhibitors.
• The breakthrough therapy targets neutrophil-mediated diseases, addressing a significant unmet medical need in non-cystic fibrosis bronchiectasis treatment.
Insmed's TPIP and Brensocatib Programs Show Promise in Rare Pulmonary Diseases
Leerink Partners maintains a Buy rating on Insmed with an $85 price target, highlighting significant potential in pulmonary arterial hypertension treatment with TPIP and brensocatib for non-cystic fibrosis bronchiectasis. The company's strategic position in addressing unmet needs in rare pulmonary diseases has sparked acquisition speculation.
Insmed's Gene Therapy Receives IND Clearance, Aiming to Transform DMD Treatment
• Insmed's novel gene therapy candidate for Duchenne Muscular Dystrophy (DMD) has received IND clearance, paving the way for clinical trials.
• The gene therapy aims to address the underlying genetic cause of DMD by delivering a functional dystrophin gene.
• Insmed's approach could offer a significant advancement over current DMD treatments, which primarily manage symptoms.
• Clinical trials are anticipated to evaluate the safety and efficacy of the gene therapy in DMD patients.
Insmed's Brensocatib NDA Accepted by FDA with Priority Review; Anticipated Launch in Q3 2025
• The FDA has accepted Insmed's New Drug Application for brensocatib in bronchiectasis, granting Priority Review with a PDUFA target action date of August 12, 2025.
• Insmed anticipates launching brensocatib in the U.S. in the third quarter of 2025, pending FDA approval, with regulatory submissions planned for the EU, UK, and Japan in 2025.
• ARIKAYCE global revenue grew 19% in 2024, and Insmed projects 2025 revenues between $405 million and $425 million, representing double-digit growth.
• A Phase 3 study of TPIP in pulmonary hypertension associated with interstitial lung disease is planned for the second half of 2025.
Elevidys Gene Therapy Shows Sustained Benefits in Duchenne Muscular Dystrophy Patients
• Sarepta Therapeutics' Elevidys demonstrates sustained benefits and disease stabilization in ambulatory Duchenne muscular dystrophy (DMD) patients, according to Phase 3 EMBARK trial results.
• Crossover-treated patients showed a 2.34-point improvement on the North Star Ambulatory Assessment (NSAA) compared to matched external controls after 52 weeks of Elevidys treatment.
• Patients treated with Elevidys in Part 1 of EMBARK maintained clinically meaningful improvements in NSAA, Time to Rise (TTR), and 10-meter walk/run (10MWR) at two years.
• Muscle biopsies showed consistent micro-dystrophin expression, and MRI scans indicated minimal muscle pathology progression, reinforcing Elevidys's long-term efficacy and safety.
Mereo BioPharma's Setrusumab Phase 3 Trial Progresses; Alvelestat Receives Positive EMA Opinion
• Mereo BioPharma's setrusumab Phase 3 Orbit study for osteogenesis imperfecta is ongoing, with a second interim analysis expected in mid-2025.
• Alvelestat, for Alpha-1 Antitrypsin Deficiency-associated Lung Disease, received a positive EMA opinion on its European Orphan Designation application.
• The European Commission is expected to make a final decision on Alvelestat's Orphan Designation in the first quarter of 2025.
• Mereo BioPharma's current cash and cash equivalents are expected to fund operations into 2027, covering key milestones.
Tonix Pharmaceuticals Bolsters Leadership as TNX-102 SL Awaits FDA Decision for Fibromyalgia
• Tonix Pharmaceuticals has appointed Bradley Raudabaugh as VP of Marketing and Errol Gould as VP of Medical Affairs to support the potential launch of TNX-102 SL.
• The FDA is expected to decide on the acceptance of the New Drug Application (NDA) for TNX-102 SL in December 2024, with a potential approval decision in 2025.
• TNX-102 SL, if approved, would be the first new drug for fibromyalgia in over 15 years, offering a novel analgesic approach for patients.
• The company also has a contract with the U.S. DoD for up to $34 million to develop TNX-4200, a small molecule broad-spectrum antiviral agent.
NCFB Pipeline Shows Promise with Over 15 Companies Developing New Therapies
• The non-cystic fibrosis bronchiectasis (NCFB) market is experiencing growth due to rising prevalence and increased awareness, leading to early diagnosis and treatment.
• Over 15 companies are actively developing more than 15 NCFB drugs, aiming to improve the treatment landscape for this chronic lung condition.
• Key players like Insmed, AstraZeneca, and Verona Pharma are advancing promising therapies such as brensocatib, benralizumab and ensifentrine through clinical trials.
• Recent clinical trial milestones, including Phase III results for brensocatib and Phase II enrollment for AP-PA02, signal progress in addressing unmet needs in NCFB treatment.
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