PARI Pharma GmbH

Savara to Present Phase 3 IMPALA-2 Trial Data on Molgramostim for Rare Lung Disease at Multiple International Conferences

2 months ago

• Savara will showcase new data from its pivotal Phase 3 IMPALA-2 trial of molgramostim for autoimmune pulmonary alveolar proteinosis (aPAP) at the American Thoracic Society International Conference in May 2025. • Two poster presentations will highlight how molgramostim reduces surfactant burden, decreases whole lung lavage procedures, and improves respiratory health-related quality of life in aPAP patients. • The company will host an Industry Theater featuring world-renowned experts Dr. Bruce Trapnell and Dr. Cormac McCarthy to discuss advances in aPAP diagnosis and management.

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.

Molgramostim Shows Sustained Benefits in Phase 3 Trial for Autoimmune Pulmonary Alveolar Proteinosis

8 months ago

• Molgramostim demonstrated a statistically significant improvement in lung diffusing capacity (DLCO%) at Week 24, which was sustained through Week 48 in aPAP patients. • The IMPALA-2 trial showed molgramostim significantly improved disease severity scores and ground glass opacification, indicative of reduced surfactant burden. • Responder analysis revealed higher proportions of patients achieving clinically meaningful improvements in DLCO% and respiratory questionnaire scores with molgramostim. • Savara plans to submit a Biologics License Application (BLA) for molgramostim in the first half of 2025, seeking approval for aPAP treatment.