Brensocatib

Non-Cystic Fibrosis Bronchiectasis Market Expected to Reach USD 7.5 Billion by 2035, Driven by Novel Therapies

2 months ago

• 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.

EMA Evaluates Fast-Track Status for Three Novel Therapeutics from Scholar, Insmed, and Soleno

3 months ago

• 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.

FDA Grants Priority Review to Brensocatib for Non-Cystic Fibrosis Bronchiectasis Treatment

3 months ago

• 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.

United Therapeutics' UKidney Xenotransplant Trial Receives FDA Clearance

4 months ago

• United Therapeutics received FDA clearance for its IND application to begin clinical trials for UKidney, a gene-edited pig kidney, marking a significant step in xenotransplantation. • The phase 1/2/3 trial will enroll ESRD patients, including those ineligible for traditional transplants and those unlikely to receive a kidney within five years. • UKidney features 10 gene edits to enhance compatibility and reduce rejection, offering a potential alternative to dialysis for patients with limited options. • The trial's primary endpoints include patient and UKidney survival rates, changes in glomerular filtration rate, and quality of life improvements over a 24-week period.

Insmed's TPIP and Brensocatib Programs Show Promise in Rare Pulmonary Diseases

4 months ago

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 Brensocatib NDA Accepted by FDA with Priority Review; Anticipated Launch in Q3 2025

4 months ago

• 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.

NCFB Pipeline Shows Promise with Over 15 Companies Developing New Therapies

6 months ago

• 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.

Caligan Partners Takes Stake in Verona Pharma, Citing Ohtuvayre's Potential

6 months ago

• Caligan Partners LP has acquired a stake in Verona Pharma, recognizing the potential value of its drug Ohtuvayre (ensifentrine) for COPD treatment. • Ohtuvayre, a dual inhibitor of PDE3 and PDE4, has shown promising Phase III data with significant lung function improvement and reduced exacerbations. • Caligan anticipates substantial revenue potential for Ohtuvayre, especially with possible expansion into non-cystic fibrosis bronchiectasis (NCFB) treatment. • Caligan's investment is based on Verona's potential to capture a significant share of the COPD market and the possibility of a lucrative acquisition.

Insmed's Brensocatib Nears NDA Filing with Strong Financial Backing

7 months ago

• Insmed anticipates filing a New Drug Application (NDA) for brensocatib in Q4 2024, with a potential launch in mid-2025, targeting bronchiectasis treatment. • The company's Q3 2024 financial results show an 18% year-over-year revenue increase, driven by ARIKAYCE sales, and a solid $1.5 billion in cash reserves. • Clinical trials for brensocatib are progressing in chronic rhinosinusitis and hidradenitis suppurativa, with results expected by late 2025, expanding its potential. • Insmed is advancing TPIP development for pulmonary hypertension, with Phase 3 trials planned for late 2024, aiming for optimized manufacturing and dosing.

Brensocatib Shows Consistent Efficacy in Bronchiectasis Subgroups: Phase 3 ASPEN Data

7 months ago

• Subgroup analyses from the Phase 3 ASPEN trial demonstrate that brensocatib shows a consistent positive impact on pulmonary exacerbation rates across most pre-specified subgroups. • Brensocatib 25 mg slowed lung function decline, measured by FEV1, across all pre-specified subgroups in bronchiectasis patients, underscoring its potential impact. • Brensocatib was well-tolerated in the study, with treatment-emergent adverse events consistent with previous findings, supporting its safety profile. • Insmed plans to file a New Drug Application with the FDA for brensocatib in Q4 2024, with potential launches in the U.S., Europe, and Japan.

Insmed's Treprostinil Palmitil Shows Promise for Rare Pulmonary Disorders with Projected $66M Revenue by 2037

8 months ago

• Insmed's innovative dry powder inhalation therapy, Treprostinil Palmitil, targets multiple rare pulmonary disorders including PAH and PH-ILD through a novel sustained-release nanoparticle formulation. • The drug candidate, targeting the prostacyclin receptor, is projected to generate annual revenues of $66 million by 2037 in the US market according to GlobalData's analysis. • Insmed demonstrates strong market presence with 24.4% revenue growth in FY2023, reaching $305.2 million, while continuing development of their rare disease therapeutic pipeline.

Drug Development Updates