Part of pari medical holding gmbh
Clinical Trials
22
16 active
Approvals
6
Total approvals
Agencies
3
Regulatory bodies
Founded
N/A
Active, not recruiting
16
72.7%
Completed
4
18.2%
Terminated
2
9.1%
- Insmed's BRINSUPRI achieved approximately $144.6 million in unaudited revenues for its first full quarter of launch, with approximately 4,000 medical professionals prescribing the therapy. - ARIKAYCE exceeded guidance with approximately $433.8 million in global revenues for 2025, with 2026 revenues projected between $450-470 million. - The company initiated Phase 3 PALM-ILD study for TPIP in pulmonary hypertension and plans additional Phase 3 studies across multiple indications in 2026. - Key clinical readouts are anticipated including Phase 3 ENCORE data for ARIKAYCE in March-April 2026 and Phase 2b CEDAR results for brensocatib in Q2 2026.
- The European Patent Office intends to grant Savara a patent for MOLBREEVI's liquid formulation, providing protection until March 2041 for this investigational autoimmune PAP therapy. - Savara was also recently granted a European patent covering the drug-device combination of MOLBREEVI with PARI's eFlow nebulizer system, extending protection through March 2043. - The company expects to resubmit its BLA to the FDA this month and plans to submit MAA applications in the EU and UK by the end of Q1 2026. - MOLBREEVI has received multiple regulatory designations including FDA Fast Track and Breakthrough Therapy status for treating autoimmune pulmonary alveolar proteinosis.
- Savara's Phase 3 IMPALA-2 trial demonstrated that inhaled molgramostim significantly improved lung function by 9.8% at 24 weeks compared to 3.8% with placebo in autoimmune pulmonary alveolar proteinosis patients. - The treatment showed sustained benefits through 48 weeks with 11.6% improvement in gas transfer, while also enhancing quality of life and exercise capacity in the largest clinical trial conducted in this rare disease. - Results from the 43-site global study will be published in the New England Journal of Medicine, marking a potential breakthrough for patients with this chronic rare lung condition.
